Newsroom

  • Pfenex Statement on FDA Release of Draft Interchangeability Guidance

    We commend the FDA on the release of draft guidance for establishing interchangeability between a biosimilar and a reference product, an important step in creating a robust market for biosimilars in the United States and ensuring greater patient access to medicines.

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  • Pfenex Statement in Response to Final FDA Guidance on Nonproprietary Naming of Biological Products

    Pfenex supports the issuance by the FDA of final guidance for naming of biologic products as a demonstration of positive momentum in creating a regulatory framework for biosimilar products in the United States, however we note the exclusion of guidance for naming of interchangeable biologic products.

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  • Bringing Biosimilars to Market

    Pfenex is a leading-edge biologics company driven by the desire to provide access to safe, effective, affordable products to market. CEO Bert Liang opens up about how he has transformed the company and become an award winning CEO.

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  • BsUFA Delays Biosimilar Guides, But FDA Says Interchangeability On Track

    An FDA official told Inside Health Policy Thursday (Oct. 27) the agency still plans to unveil the draft interchangeability guidance for biosimilars in 2016, even though the agreement for second iteration of biosimilar user fees says the guide will be delayed until 2017. The BsUFA II agreement, expected to be sent to Congress by the end of the year, stretches out timelines for guidances on key issues, including interchangeability and naming, prompting outcry from generic drug industry, health care professionals...

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  • Breaking Down Barriers to Patient Access

    Imagine you are diagnosed with a difficult to treat chronic condition such as rheumatoid arthritis or Crohn’s disease. You’re prescribed a biologic drug, which effectively manages your symptoms, however creates a strain on your bank account. You quickly join countless Americans faced with making some difficult choices at a particularly vulnerable time — paying for essential treatment options, or foregoing such options due to the hardships it would cause.

    Unfortunately, this challenge is common to many patients prescribed a biologic medicine. Biologic use is widespread — seven of the top 10 selling pharmaceuticals in 2015 were biologics. These therapies are effective and crucial; however, they are often costly. The price of the average biologic is more than 22 times that of a traditional pharmaceutical drug, due to significantly higher development costs. Current estimates find biologics at 40 percent of total prescription drug spending, anticipated to rise to over 50 percent by 2018. The sustainability of such spending for these important medicines is questionable.  However, there is an answer.

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  • FDA says trust and education critical for biosimilars

    The US Food and Drug Administration (FDA) has highlighted trust and education as critical factors in ensuring patient access to biosimilars.

    In a keynote address at the Generic Pharmaceutical Association’s (GPhA) annual Biosimilars Council Conference, Dr Janet Woodcock, Director of the FDA Center for Drug Evaluation and Research (CDER) emphasized the importance of education and the need for patients, providers, pharmacists and others to trust in the science that enables FDA to approve biosimilars as safe, effective alternatives to costly brand-name biologicals.

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  • Bio-synonyms: describing biosimilars without saying ‘copycats’ or ‘knock-offs’

    Terms such as ‘copycats’ and ‘knock-offs’ are inaccurate and misleading, say drug makers. We ask therefore how industry and the media should refer to biosimilar products?

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  • Pfenex Inc. Announces Formation of Scientific Advisory Board

    SAN DIEGO, October 19, 2016 — Pfenex Inc., a clinical-stage biotechnology company engaged in the development of biosimilar therapeutics and high-value, difficult to manufacture proteins, today announced the development of a Scientific Advisory Board (SAB) to provide expert guidance and insight as the company advances towards product commercialization. Members of the SAB will assist the company as it navigates process development and moves closer to product commercialization.

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  • The State of the Biosimilars Industry

    Pfenex Inc. CEO, Dr. Bert Liang, discusses the state of the biosimilars industry with Pharmaceutical Processing. There is momentum in the space as the U.S. Food and Drug Administration (FDA) has published a number of biosimilar guidances and two biosimilars have been approved. FDA said at a June event there are 60 biosimilar products in development and nine applications have been submitted for biosimilar approval. Naming, coding, and interchangeability are some of the key policy issues taking shape, and education is paramount to driving uptake, according to Dr. Liang.

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  • Will the approval of Inflectra be a biosimilar adoption tipping point?

    The approval of Inflectra™ (infliximab) in April was a tipping point for biosimilars in the U.S. Inflectra was the first complex monoclonal antibody biosimilar to be approved in in the U.S., a sign that regulators are comfortable with the biosimilar approval path, Pfenex Inc. CEO Bert Liang told BioPharma Dive. Knowledge of and experience with biosimilars in other parts of the world is impacting the U.S. market, and that there is a growing sense of momentum and increased demand in the space.

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  • A Perspective on the Medicare Part B Drug Experiment

    The Center for Medicare & Medicaid Innovation (CMMI), a part of the Centers for Medicare and Medicaid Services (CMS), recently issued a proposal of a mandatory experiment designed to evaluate mechanisms to reduce expenditures on prescription drugs reimbursed through Medicare Part B. This proposal would dramatically affect all those within the Medicare ecosystem, and has generated significant controversy since its unveiling. With consideration of both points of view, as a former practicing physician and scientist, and having been involved in the healthcare industry for over 20 years including leading teams developing a number of products which have addressed unmet medical needs, the implications of this mandatory “experiment” is deeply concerning, which could have significant implications on patient care.

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  • Pfenex Chief Business Officer Patrick Lucy to Present Corporate Overview at BIO2016

    Pfenex Chief Business Officer, Patrick Lucy, will present an overview of Pfenex and its product pipeline, including biosimilar candidates to BETASERON® (interferon beta-1b) for the treatment of Multiple Sclerosis and NEULASTA® (peg-filgrastim) for the treatment of neutropenia; as well as therapeutic equivalent to FORTEO® (teriparatide) for the treatment of osteoporosis; and next-generation recombinant Protective Antigen anthrax vaccine. Learn how the Company’s proprietary expression technology—the Pfenex Expression Technology®—enables it to create expression strains to make non-glycosylated proteins at high quality, and low costs.

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  • The Biosimilars Council: Why Trade Organizations Are Key for Biosimilars

    As the biosimilar market in the U.S. develops, a growing number of biopharma companies are stepping forward to shape the policies that will impact the market’s growth. Many of these companies, whether they be big pharma, generics and biotech companies, and/or pure-play biosimilar companies, are becoming members of a number of trade organizations that have been cropping up over the past year. We sat down with Dr. Bert Liang, chairman of the council and CEO of biosimilar company Pfenex, to discuss the Generic Pharmaceutical Association Biosimilar Council as one of these groups, and a support system for the burgeoning market in the U.S.

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  • Pfenex Chief Medical Officer Hubert Chen to Share Clinical Expertise at Biosimilars & Biobetters Congress

    Dr. Hubert Chen, M.D., Chief Medical Officer of biosimilars company Pfenex, will present a case-study example illustrating best practices in clinical development for a biosimilar candidate to Interferon beta-1b for the treatment of multiple sclerosis.

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  • Is FDA Biosimilar Regulatory Process Defeating Purpose of BPCIA?

    According to Dr. Bert Liang, CEO of the biosimilar company Pfenex, the establishment of the Biologics Price Competition and Innovation Act (BPCIA), at least conceptually, has been more efficient than Hatch-Waxman. However, when it comes to developing the policies that will shape the biosimilar market and ultimately impact its success, Liang says that there is a lot of reinventing the wheel.

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  • Addressing the FDA’s 2016 Agenda: Biosimilars Must be a Top Priority

    These are eventful times for U.S. healthcare. Two of the most of the most significant developments over the last year were U.S. Food and Drug Administration’s (FDA’s) approval of the first biosimilar in the U.S. and, more recently, the Arthritis Advisory Committee recommending approval of Celltrion’s CT-P13. By finalizing guidances in areas such as biosimilar interchangeability, and by facilitating timeliness in biosimilar review and approval, the FDA has the opportunity to significantly impact our nation’s healthcare.

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  • Pfenex CEO and Biosimilars Council Chair Dr. Bert Liang to Host Panel Discussion on Key Biosimilar Issues at GPhA Annual Meeting

    Panel discussion at Generic Pharmaceutical Association Annual Meeting with biosimilar, pharmaceutical, and healthcare industry leaders to explore the numerous key policy issues in play that will directly impact the uptake of biosimilars in the U.S.

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  • Biologics Naming: WHO Final Plan, FDA Draft Guidance Incompatible

    US regulators could try to harmonize its nonproprietary naming approach with World Health Organization's biological qualifier system or stick with its suffix-based proposal; while having different names across the globe for a single product is not ideal, it's also not an insurmountable problem, experts say. Bert Liang, CEO of Pfenex, shared with The Pink Sheet why the WHO and the FDA’s naming proposals both have concerning elements for biosimilar uptake.

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  • CMS biosimilar coverage is at odds with its own biologics policy

    In a move that could hamstring the U.S. biosimilars market before it has a chance to fully open its doors, the Centers for Medicare & Medicaid Services (CMS) is sticking to a Part B biosimilars payment policy that would create a bifurcated biologics scheme when older proteins such as insulin and growth hormone are brought under the Biologics Price Competition and Innovation Act (BPCIA) in 2020, Pfenex Inc. CEO Bert Liang told BioWorld Today.

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  • Preparing for biothreats: Bills S. 2055 and H.R. 3299

    Historically, Congress has funded the Biomedical Research and Development Authority (BARDA) to facilitate the development of MCMs, partnering with industry. Congress also authorized a 10-year appropriation of $5.6 billion (Project Bioshield) to purchase such MCMs to protect the American public from biologic attacks.

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