A new study abstract released today in Norway demonstrates support for switching patients from an branded biologic to a biosimilar for treatment. The Nor-Switch study, which will be presented at the United European Gastroenterology Annual Congress Week (UEGW), examined patients that either continued treatment with the branded biologic infliximab (Remicade), or switched to a biosimilar, infliximab (CT-P13 Remsima).
As a result, study data found “no significant difference in effect, adverse effects or antibody formation” in subjects, lending support to biosimilar switching for an approved condition and chipping away at a significant barrier to biosimilar market uptake. By demonstrating support for biosimilar switching, this study underscores the safety and efficacy of a biosimilar when compared with a biologic, and encourages greater use of the biosimilar, ensuring patients have greater access to essential lower cost therapies.
Sandoval to lead process development, manufacturing and quality operations for leading-edge biosimilar developer
Pfenex Inc., announced that Steven. S. Sandoval Sr. has joined the company as Chief Manufacturing Operations Officer, focused on leadership of process development, clinical and commercial manufacturing and quality operations.
Sandoval joins Pfenex with over 25 years of commercial biopharmaceutical engineering and operations experience, specializing in commercial operations, facility design and licensure of large scale biopharmaceutical commercial manufacturing facilities. He has extensive knowledge of cGMP biopharmaceutical engineering as well as significant first-hand experience preparing for and interfacing with the FDA and other global regulatory agencies during pre-licensure and biennial inspections of commercial cGMP biopharmaceutical manufacturing facilities.
Prior to joining Pfenex, Sandoval was a member of Amgen’s site executive management leadership team responsible for the aggressive growth at the Puerto Rico manufacturing site, where he led the engineering team in taking a large scale $600MM biopharmaceutical multiproduct manufacturing facility from conceptual design to licensure in two and half years.
“Steven’s wealth of experience will have a direct impact on Pfenex at a crucial inflection point as we advance our portfolio of products toward commercialization,” said Bert Liang, President & CEO, Pfenex Inc. “We are thrilled to welcome Steven to our growing and dynamic team.”
Pfenex applauds Senators Patrick Leahy (D-VT), Chuck Grassley (R-IA), Amy Klobuchar (D-MN), and Mike Lee (R-UT) for their efforts introducing the Creating and Restoring Equal Access to Equivalent Samples Act (CREATES Act). The Act supports access to reference product for biosimilar development, thereby expediting patient access to valuable medicines.
Biosimilar developers must obtain samples of the reference product in order to conduct the necessary scientific tests to gain U.S. Food and Drug Administration (FDA) approval. Branded drug manufacturers often enact barriers to biosimilar developer access to reference product, such as by refusing to sell product to them, or impeding participation in FDA-required safety protocols. The CREATES Act would prevent such transgressions by authorizing a judge to award damages for preventing access to a reference product, and it would allow court-supervised negotiations between branded drug companies and biosimilar developers.
We look forward to lawmaker discussion around this important legislation as an important step toward expanding patient access to life-changing medications.
In March of 2016, a provision was added to the FDA and NIH Workforce Authorities Modernization Act (S. 2700), that would exempt biological medicines from the requirement to adhere to U.S. Pharmacopeial (USP) standards for quality. The provision appears to be unrelated to the content of the larger bill, and it seems to have been added at the last minute and without sufficient stakeholder input during Health, Education, Labor and Pensions (HELP) committee markup.
Pfenex is aligned with the Generic Pharmaceutical Association, USP, the American Pharmacists Association, and other stakeholders that, if passed, this provision could remove important global drug quality and safety standards that have been in place since 1906. These longstanding and publicly-recognized standards are used in more than 140 countries around the world, helping to ensure patient, provider, and pharmacist confidence in the safety, and quality, of medications. For drug developers, USP standards provide a set of global, nonproprietary benchmarks for drug purity, potency, identity, and quality to which manufacturing specifications must adhere.
The standards encourage competition in the marketplace which can facilitate increased patient access to life-changing therapies. We urge legislators and the U.S. Food and Drug Administration (FDA) to reject this provision so that providers and patients can continue to have access to biological medicines of the highest quality.
Pfenex is pleased that the U.S. Food and Drug Administration (FDA) approved the second biosimilar in the U.S., Celltrion’s Inflectra™. Until today, this treatment—infliximab, which is used to treat rheumatoid arthritis and other inflammatory diseases--existed only as a branded biologic. The approval of a biosimilar product has the potential to provide thousands of patients across the nation with access to a more affordable and equally-effective alternative.
Further, the acknowledgement by the FDA that the data package provided by Celltrion was sufficient to address the scientific considerations for extrapolation across indications demonstrates the effectiveness of the biosimilars pathway as set forth in the Biologic Price Competition and Innovation Act. We applaud the FDA for taking this step and look forward to additional guidance to further facilitate the development of a robust biosimilars market in the U.S., with the potential to significantly reduce healthcare costs and increase patient access to life-changing treatments.
Pfenex is pleased the U.S. Food and Drug Administration (FDA) has fulfilled its commitment to publish draft guidance related to biosimilar product labeling. The draft guidance is an incremental step toward the development of a robust biosimilars market in the U.S. However, there are potential areas for improvement to ensure patients and providers understand that the biosimilar product is as safe and effective as the reference drug.
The draft FDA guidance recommends that, in the biosimilar product label, applicants incorporate relevant data and information from the reference product labeling with appropriate product-specific modifications, without further need for biosimilar specific product description. This guidance directly aligns with the FDA’s articulations on biosimilar development. A clinical study supporting the licensure of the biosimilar product generally would serve to support a demonstration of no clinically meaningful differences between the proposed biosimilar product and the reference product for the approved indications. As such, Pfenex believes these guidance recommendations support the formation of a robust biosimilars marketplace.
The draft guidance also proposes a “statement of biosimilarity” to distinguish a biological product as biosimilar to a reference product in the “Highlights” section of the label. Pfenex is concerned that calling out a product as biosimilar to another in this way could confuse patients and providers as to whether they are receiving the treatment prescribed. Without sufficient patient and provider education around biosimilar safety and efficacy, this statement of biosimilarity could undermine confidence in the biosimilar product, which could hinder market development, and uptake. As biosimilars have no clinically meaningful differences from the reference product, the footnote would only serve to diminish, rather than clarify, the FDA’s notation that the pathway to approval does not impact the safety and efficacy of a given product.
Finally, the draft guidance does not provide recommendations for the labeling of interchangeable biosimilar products, explaining that interchangeability guidance is forthcoming. We eagerly await this much-needed guidance which is a key component to providing biosimilar manufacturers with a clear framework for presenting biosimilar packages to the Agency for review.
Pfenex applauds the FDA’s Arthritis Advisory Committee for recommending approval of Celltrion Inc.’s infliximab biosimilar, CT-P13, with full extrapolation to all indications. Infliximab currently exists in the US only as the branded biologic Remicade, and the addition of another treatment on the market could provide thousands of patients across the nation with access to a more affordable, and equally-effective alternative. Other geographies such as Europe—which already has more than 20 approvals—are reaping the benefits of the significantly improved patient access and healthcare savings that biosimilars provide. The recommended approval of CT-P13 from the FDA’s Arthritis Advisory Committee is a step toward creating a robust biosimilars market in the United States, which could significantly reduce our healthcare costs, while increasing patient access to life-changing therapeutics. We applaud the Committee for taking this step to bring the second biosimilar to the U.S. market and hope that, with additional guidance from the FDA, the biosimilars market will continue to grow.
Last week, The House Energy & Commerce Committee’s Subcommittee on Health held a hearing examining the Biologics Price Competition and Innovation Act (BPCIA)’s implementation in our healthcare system – an important issue that affects many Americans. The hearing featured insight from Janet Woodcock, the director of the Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER), and Sean Cavanaugh, the Deputy Administrator and Director of the Center for Medicare and Medicaid Services (CMS)’s Center for Medicare.
Enacted in 2010, the BPCIA was designed to be an abbreviated pathway for biosimilar approval in the U.S. In support of this, the Biosimilars User Fee Act (BsUFA) was enacted in 2012 to expedite the review of biosimilars. However, even with these pathways in place, there has only been one biosimilar approved for patient use in the U.S. in the past five years. At this pace, it is safe to say that our biosimilar market is growing far too slowly. We need sound policies established by FDA and CMS that encourage widespread adoption to allow increased patient access to lifesaving treatments at lower costs.
Prescription drug prices continue to rise faster than inflation to the point where they are unaffordable for many U.S. patients. Now more than ever, biosimilars need to be part of the solution. Defined by the FDA as having “no clinically meaningful” differences from their reference products, biosimilars are safe, effective, and affordable alternatives to costly biologic drugs. They have been used in geographies outside the U.S. for years—Europe has used them for more than a decade, has more than 20 biosimilar drugs approved, and is enjoying significantly improved patient access and healthcare savings as a result. Enacting policies that facilitate their entry into the U.S. market would relieve the burden that is placed on our current healthcare costs by increasing competition while providing thousands of patients with access to life-saving therapies.
We agree with the Subcommittee’s sentiments from Thursday’s hearing that the FDA needs to publish additional guidance to ensure that the 60 biosimilar applications currently in its pipeline see timely approval, particularly with regard to naming, labeling, and interchangeability. The FDA should learn from Europe’s more than a decade of experience and assign the same INN to biosimilars as to their reference product. A robust biosimilars market supported by clear, comprehensive FDA guidance in the U.S. could lessen the burden of our healthcare costs while simultaneously providing thousands of patients access to life-saving treatments.
We also share the Subcommittee’s sentiment about CMS’ current reimbursement policy for biosimilars, and encourage them to review it in such a way that it doesn’t stifle the emerging market. More specifically, we believe each biosimilar product should have an individual Healthcare Common Procedure Coding System (HCPCS) code, which is in accordance with the Biologics Price Competition and Innovation Act.
We hope the FDA and CMS use the feedback gathered from this hearing to enact policies that best ensure biosimilar uptake, and we applaud the Subcommittee for holding a productive, thoughtful hearing on the subject.
Share your thoughts on last week’s hearing with us on Twitter at @Pfenex.
Pfenex’s full statement on Thursday’s hearing is below:
Pfenex applauds the House Energy & Commerce Committee’s Subcommittee on Health for holding a hearing to ensure the implementation of the Biologics Price Competition and Innovation Act (BPCIA). As discussed in the hearing, the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) must create policies that support a strong biosimilar market in the U.S.
Since the implementation of the BPCIA in 2010, there has only been one biosimilar approved in the U.S. As prescription drug prices continue to rise—a recent survey of 3,000 prescription drugs finding numerous branded drugs have more than quadrupled in cost since 2014—biosimilars are needed now more than ever. They are more affordable than and equally as effective as biologic drugs; they have the potential to save our healthcare system billions of dollars, and they increase patient access to life-saving therapies. Additionally, biosimilars allow more resources to be devoted to new drug innovations. Pfenex applauds the Committee members for using Thursday’s hearing as a forum to encourage the FDA to release much-needed guidance on interchangeability. Such guidance is critical to encouraging new entrants into the biosimilar market and is expected to create a robust, competitive industry for biosimilars in the U.S. It is imperative that all parties work together to address these key policy questions and enact sound policies that encourage widespread adoption. We hope the FDA and CMS use the feedback received to enact such policies in the coming year.
At Pfenex, we’re focused on the development of biosimilars, drugs similar to generics, but different in the sense that they are produced from a living organism. Despite this difference, there are similarities and trends we see in the generics market that we can anticipate for biosimilars – notably the tremendous impact that generics have had on lowering cost and increasing patient access.
High drug costs are nothing new. In fact, the prices of brand-name drugs have almost doubled since 2008, according to a 2014 Express Script Drug Trends report. Conversely, generic drugs continue to see prices fall, with the second quarter of 2015 seeing a price decline for nearly 44 percent of generics, as reported by an August 2015 Drug Channels blog post. These trends speak for themselves - generic drugs are part of an effective long-term solution to the rising costs of healthcare.
This week, the Generic Pharmaceutical Association (GPhA) released its 7th Annual Generic Drug Savings in the United Sates report, compiled by the Institute for Healthcare Informatics (IMS), which revealed that the use of generics has saved the United States’ healthcare system a record-breaking $254 billion in 2014, bringing total savings over the past decade to an impressive $1.68 trillion.
These savings can be further realized with the maturation of the US biosimilars market. According to the FDA, biosimilars have no clinically meaningful difference from their reference product. A robust biosimilar market would give American patients greater access to biologic products that can be life-changing for many people with chronic conditions. It is also worth noting that in countries with such markets, biosimilars have historically cost 20 to 30 percent less than their reference products, a trend that is likely to replicate once the US biosimilars market reaches its full potential.
But, as with most markets, in order to maintain low prices, there needs to be an increase in competition. It’s important that policymakers encourage a regulatory environment that ensures a market that enables competition between biosimilars and the branded counterpart. It is not enough to create competition between biosimilars alone.
In order to recognize the full potential of biosimilars in the US, including lower prices and increased access, it is critical that the FDA and other regulatory bodies implement policies to increase competition, while urging regulators to consider policies, such as a naming system and interchangeability guidelines, that will create a thriving, competitive biosimilars market.
Pfenex applauds the Centers for Medicare and Medicaid Services (CMS) for its efforts to create a clear reimbursement framework for biosimilars through the issuance of the 2016 physician payment rule, which provides guidance on reimbursement for biosimilars under Medicare Part B.
However, we are not supportive of the decision to group all biosimilars to a single reference product under the same Healthcare Common Procedure Coding System (HCPCS) code, with the reference product maintaining a separate code. We remain concerned that the current proposal will hinder biosimilar uptake and discourage innovation by not establishing a reimbursement model for biosimilars based on a product’s unique average sales price (ASP).
As defined by the U.S. Food and Drug Administration (FDA), biosimilars are proven to have no clinically meaningful difference in safety, purity, and potency from a reference product. Because biosimilars are comparatively developed to a given reference product, rather than other biosimilars, it is illogical to tie reimbursement to other molecular entities to which the biosimilar was not initially compared. As such, we believe each product should have an individual HCPCS code, which is in accordance with the Biologics Price Competition and Innovation Act (BPCIA). Such a policy will better ensure innovation and drive market entry, ultimately allowing the U.S. to realize the full promise of biosimilars. We encourage lawmakers and regulators to enact policies that ensure the U.S. is an environment conducive to therapeutic innovation and adoption.
Presidential hopefuls and current elected officials alike have recently revealed various plans to address the issue of increasing drug prices. Some favor greater government involvement; others promote patent reform; others favor changes to the Affordable Care Act. There are certainly a great number of theoretical ways to effectively reduce drug prices, but, time and time again, we have seen one consistent practice drive down prices across the board: competition, from both innovator drugs and generics.
This idea was the focus of a recent op-ed in The Wall Street Journal titled “The Answer to High Drug Prices Is More Drugs, Faster,” penned by Dr. Tom Coburn, former senator from Oklahoma and an adviser to Project FDA at the Manhattan Institute, and Michael Howard, senior fellow and director of health policy at the Institute. In the goal of providing the best and most innovative drugs to patients, competition is key – for both innovator drugs and their follow-on counterparts.
Biosimilars, in particular, are key for this competition. Biosimilars are lower-cost alternatives of biologic drugs, which include many of the specialty, high-cost drugs used today to treat chronic diseases like cancer and diabetes. The biosimilar market is the U.S. is still in its infancy, with only one approved biosimilar on market today. Looking at a mature biosimilar market, however, like those in Europe and Australia, shows the immense benefits a robust biosimilars market has on driving down drug prices and increasing access. In fact, in Europe, discounts of biosimilars are around 30 percent on average. And, with such significant savings on drug costs in the healthcare system, more investment can go into the development of new, innovative therapies.
In order to reap these cost-reduction benefits, the U.S. needs a competitive biosimilars market – and, to create that, regulatory agencies like the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) need to issue policies that support the development and uptake of biosimilars. In this effort, we urge the FDA to support the use of the same INNs for biosimilars and the products they reference, and for the CMS to create rules that allow the same HCPCS code for biosimilars and their reference products. Both of these actions will allow doctors to prescribe these safe and effective therapies with ease, increasing their use and encouraging more companies to enter the biosimilars market – thus, increasing competition and driving prices down further.
Competition is key to reducing high drug costs – and biosimilars, in particular, will play a critical role in the U.S. to lower the cost of specialty biologic drugs. Let’s embrace this powerful tool for increasing patient access and promoting innovation by putting in place policies that provide a clear development pathway for companies and promote biosimilar uptake among physicians and patients.
Pfenex applauds Sens. Pat Roberts (R-Kan.) and Tom Carper (D-Del.) for their leadership, along with a group of 20 bipartisan U.S. Senators, in urging Acting CMS Administrator Andrew Slavitt to call on the agency to withhold its biosimilar reimbursement policy until the FDA has finalized its regulations regarding biosimilars. As Sens. Roberts and Carper detail in the letter sent yesterday, it is premature for CMS to issue a final rule on the coding and reimbursement of biosimilars before the FDA has released further regulations on biosimilars, most notably on the issues of naming and interchangeability.
The biosimilars market in the U.S. is still in its infancy. It is critical that CMS and FDA to work together to put forward sound policies that support this growing industry, and increase physician and prescriber adoption of biosimilars, ultimately allowing greater patient access to these safe, vitally important therapies. We commend the leadership of this bipartisan group of Senators and urge CMS to act prudently and withhold a final rule on biosimilar reimbursement until there further guidance from the FDA is available.
Pfenex congratulates Sandoz on the launch of the first FDA-approved biosimilar, Zarxio. The launch of this biosimilar, a first-of-its-kind in the United States, is a critical win for patients and the U.S. healthcare system. Today, patients throughout the country have access to a safe, more affordable alternative innovative therapy – access other geographies have enjoyed for nearly a decade.
Now, it is imperative that regulatory agencies work together to create policies that foster the continued growth of the US biosimilars marketplace, ensuring greater access to safe and affordable biosimilars for patients and cost savings for the healthcare system. Specifically, policies that streamline reimbursement and create clear guidelines for naming and interchangeability are critical to developing a positive environment for biosimilars adoption.
Pfenex is committed to working closely with all stakeholders to educate patients, providers, physicians and lawmakers on the safety and importance of these innovative therapies.
Pfenex applauds the Food and Drug Administration (FDA) in providing for comment the proposed rule and guidance for the naming of biologics and biosimilar products. While we agree with the FDA that the assignment of a random four letter code to each biologic and biosimilar product could potentially “avoid inaccurate perceptions of the safety and effectiveness of biological products based on their licensure pathway”, it remains the position of Pfenex that biosimilars should be given the same International Nonproprietary Name (INN) as the reference biologic product both to achieve the articulated goal of the FDA, and to support the use of biosimilars in the United States, mimicking successful and safe naming conventions used for years in other geographies such as the EU. The additional suffix proposed will needlessly complicate the prescribing system and create confusion between physicians and pharmacists.
As the market for biosimilars continues to grow in the U.S., it is imperative that the FDA and other regulatory bodies enact rules to increase access to therapies such as biosimilars for patients. We thus urge the FDA to support a system of same INNs for biosimilars and the reference product to increase patient access, as well as encourage competition within the market, ensure patient safety and avoid confusion among providers and dispensers.
Drug access for millions of patients could be hampered under the intellectual property terms proposed by the Trans-Pacific Partnership (TPP). The TPP, a proposed trade agreement between 12 countries, will influence 40 percent of the world’s global trade when finalized and, in each of the signing countries, elements such as intellectual property regulations will become law for the duration of the agreement. In its current form, the TPP would provide expanded patent protection for some of the most expensive drugs being produced, meaning these drugs would not face competition from other producers.
More specifically, the proposed terms in the TPP would expand the United States’ drug patent protection of 12 years to all TPP partners. This patent exclusivity means that during this time, no other drug producer can create a product to compete with that medication. While periods of patent exclusivity exist in other TPP countries, none are as long as the U.S.’ of 12 years, meaning this provision of the TPP would lengthen patent protection for biologics and specialty drugs in all 11 of these countries. Ultimately, this expansion will prevent expensive branded drugs from facing market competition, ensuring prices remain high and the drugs stay out of reach for many patients with chronic or life-threatening diseases.
The U.S. and Japan have been the strongest supporters of these intellectual property regulations, but it has faced its fair share of criticism from patient advocates. Proponents of the current form of the TPP claim that because biologics require significant investment and long development periods, they require lengthy exclusivity periods. Without them, they claim innovation would be stifled. However, we have seen that the effects of these long exclusivity periods far exceed “recouping research costs.”
In 2010, Medicare Part B spent more than $8 billion on the biologics that make up eight of its top ten most costly drug regimens, and drug prices keep increasing. From 2013 to 2014, prescription drug spending in the U.S. soared from 2.5 percent to 12.6 percent, according to a recent report from the Centers for Medicare & Medicaid Services (CMS). Competition for costly biologic drugs is needed to ease the burden on global healthcare systems and patients.
The stakes are incredibly high for millions of people seeking care. The biologic market has proven itself to be robust, innovative, and profitable, but now patient access needs to be a priority for governments. The TPP will impact countries without healthy payer systems, and excessive exclusivity periods will effectively prohibit patient access to specialty medications that could save their lives or relieve chronic conditions. Because of the profound impact the requirements will have on millions of people for years to come, we urge world leaders proceed with caution and consider the far-reaching impacts of this agreement.
Pfenex applauds Reps. Susan Brooks and Anna Eshoo for their bipartisan leadership on strengthening our national biodefense programs through the introduction of H.R. 3299. The Strengthening Public Health Emergency Response Act of 2015 offers two key provisions that will play a major role in supporting the U.S.’ biodefense and biosecurity efforts, ultimately ensuring the safety of the American people.
Pfenex supports the Priority Review Voucher (PRV) provision in H.R. 3299, as we have long held that Congress should provide PRVs to encourage the development of medical countermeasures (MCMs) for the 13 deadly pathogens identified by the Department of Homeland Security as national security threats. We are also supportive of the bill’s provision to amend the Biomedical Advanced Research and Development Authority (BARDA) contracting process. This legislation would allow BARDA to manage its own MCM development and procurement contracts, as it has in the past, and ensure BARDA can successfully carry out its unique national security mission within the Department of Health and Human Services.
We look forward to the successful passage of H.R. 3299 through Congress as an important step to strengthening our biodefense programs, thereby supporting the safety of the American public.
For the last two months, biologics companies have been closely watching the case of Amgen v. Sandoz. This case represents a critical turning point in the U.S. biosimilars development landscape. It is no surprise, then, that Tuesday’s decision by the Federal Circuit Court in this landmark case was met with a strong response from the industry. In its ruling, the Court held that:
Why is this case so important to biologics and biosimilars producers? Most importantly, Amgen v. Sandoz provides important clarity for both biosimilar and originator companies regarding the BPCIA approval pathway and allows an expeditious avenue for resolving patent disputes. To examine this more closely, let’s take a look at each part of the decision and what it means for the future of biosimilars in the U.S.:
The first part of the decision offered a big win for biosimilars sponsors, allowing them an important choice: whether to devote resources to appeasing the complex, multi-step ‘patent dance’ or opt out of the process. But – while the first part of the ruling was a clear win for biosimilars producers – there are reasons to be wary of part two of the decision. The 180-day notification period means the biosimilar cannot be launched until six months have passed following FDA approval. But, while this directive gives pause, it’s important to note that many biosimilars are likely to be driven through patent expiry rather than data expiry. Biosimilar producers have the opportunity to plan this six month period to coincide with these expirations, which would mean that the biosimilar could potentially hit the market sooner, resulting in potentially less impact on patients.
Pfenex is primed to bring biosimilar therapies to the market. Our unique expression platform allows us to develop molecules efficiently and accurately. Because of this, we can rapidly develop proteins and products- meaning that even with the delay period, we will bring less-expensive drug alternatives to patients in a timely manner. You can learn more about the Pfenex Protein Production Platform and how this unique technology drives our pipeline here.
Overall, we are pleased with the decision and believe that as regulation and litigation continue to clarify the BPCIA, the system will become more standardized. Biosimilars producers and reference product manufacturers will be able to work through the development and approval process more smoothly–ultimately allowing even more patients access to these life-changing medications.
For more, read our full statement on the ruling.
We applaud the decision of the Federal Circuit Court to uphold the Northern District of California court ruling that the patent exchange provisions ("patent dance") as outlined under the Biologics Price Competition and Innovation Act (BCPIA) is optional; however we are cautious with the approach of the courts to section two of the ruling, which notes the 180 day notification of launch of the biosimilar cannot be before FDA approval of market authorization.
Biosimilars play a critical role in increasing access to much needed, life-impacting treatments, as seen through the tremendous success of these drugs in Europe and Australia. Once allowed to reach full potential in the U.S., these drugs stand to reduce the burden of healthcare costs and increase access for patients with debilitating diseases. In order to be most successful, it is crucial that government policies create a market that fosters healthy competition between product manufacturers. Through this ruling, while the court has provided a welcome clarification of the usage of the patent exchange provision between the biosimilar and the reference product manufacturer, it has allowed reference product producers an additional six months of diminished competition following a biosimilars approval, thus minimizing both the cost savings and patient access which biosimilar products provide.
Pfenex, as a pure play biosimilars producer, is positively positioned to advance biosimilars proliferation throughout the market. Our unique Protein Expression Technology has the potential to create biosimilars with a fingerprint-like identity to a reference product as determined through robust bioanalytics, allowing us to rapidly develop and create high-quality biosimilars products. With eight biosimilars candidates currently in the pipeline, we are excited at the potential market growth of the these life-changing drugs; however, we urge regulators and legislators to consider the impacts of this ruling on payers, patients and the healthcare system as a whole. Pfenex looks forward to continuing to work closely with stakeholders to create a streamlined path forward for these products that increases patient access and creates a robust global marketplace.
What are Biosimilars?
Biosimilars are comparable to generic drugs, expect that they are based on biologics—drugs produced from a living organism—rather than pharmaceuticals, which are made from synthetic chemicals. These relatively new drug therapies are extremely powerful. Both biosimilars and the biologics upon which they are based treat some of the most common but complex and life-threatening diseases, such as diabetes, arthritis, cancer—with incredible results.
Why Do We Need Biosimilars?
Because biologics are very, very expensive—costing patients as much as $100,000 a year. Biosimilars, which are based on these biologics and are just as safe and effective, cost 20 to 30 percent less than original (or “reference”) biologics. These cost savings allow patients expanded access to these complex drugs, here in the United States and across the world. By improving access to biologics through biosimilars, we ensure all patients can take advantage of these life-changing treatments.
But biosimilars don’t just save individuals and families money—they save whole healthcare systems money as well. For example, savings generated by biosimilars from 2007 through 2020 could be as much as €33 billion in eight European Union countries alone. The introduction of biosimilars in the U.S. could save the American healthcare system up to $250 billion by 2024, and the U.S. federal government more than $12 billion in their first ten years on the market.
Are Biosimilars Safe and Effective?
Yes. For years, biosimilars have been safely used by patients in Europe, Australia, and other countries. In the U.S., biosimilars are only approved by the Food and Drug Administration (FDA) when they are proven to have no clinically meaningful differences in terms of safety, purity, and potency when compared to the original biologic product. Biosimilars must undergo rigorous testing and are only approved when they are proven to deliver the same benefits to patients as the original.
The Pfenex Difference
Pfenex’s robust, industry-leading bioanalytical approach to biosimilars development ensures our products have the potential to achieve a fingerprint-like copy of the original biologic. Put bluntly—nobody in the biosimilars marketplace can match Pfenex for accuracy or effectiveness.
See below to take a look at our current product pipeline. And click here for more information about our products and how we develop them.
The Pfenex Expression Technology platform is unique, and effectively positions our company to serve a wide range of unmet needs via rapid, reliable protein production and product development.
At Pfenex, we believe that there is minimal or no advantage to simply repeating an innovator’s decades-old protein expression and bioprocess strategy. Instead, our platform combines an extensive toolbox of expression components with a robotically-enabled, high-throughput parallel strain screening technology.
Matched with our world class bioanalytical approach, our platform gives us the ability to produce fingerprint-like copies of original biologics—at unprecedented speeds and for a fraction of the costs of our competitors.
We are leveraging the Pfenex Expression Technology platform to build a comprehensive portfolio of biosimilar protein molecules, as well as create a national reserve of vaccines in a cost-effective and efficient manner that is unparalleled by our competitors.
Pfenex currently has nine biosimilar molecules in development. Our lead product candidate is PF582, a biosimilar candidate to Lucentis, a treatment of retinal diseases, which achieved more than $4 billion is global sales in 2013.
Our next most advanced product candidate is PF530, a biosimilar candidate to Betaseron (interferon beta-1b), a treatment for multiple sclerosis that achieved global sales of $1.4 billion in 2013.
The Pfenex development pipeline includes five other biosimilar product candidates, as well as vaccine, generic, and next generation biologic candidates. All were developed on our unique development platform and via our unparalleled bioanalytical approach.
Why We Are Different
Pfenex is unique in our industry. We are a company that combines a proven protein production technology and bioanalytical expertise with a core focus on bringing biosimilars to market. Quite simply, we develop and produce the highest quality products available. Our patients rely on our products, and doctors trust their safety and efficacy. Through these efforts, we are expanding access to life-changing biologics to people who otherwise couldn’t afford or access them.