Pfenex, Biosimilars, and Better Health

The pace of development in the biopharmaceutical industry is nothing short of staggering. Pfenex is proud to play a leading role in delivering the safest and most effective biosimilar in the marketplace. But what are biosimilars, and why do we need them? Below, we take a look at the answers to these questions.

 

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.

Therapeutics

PRECLINICAL/
BIOANALYTICAL
CHARACTERIZATION
COMPARATIVE
CLINICAL
STUDY
TOTAL SALES OF
BRANDED REFERENCE DRUGS (2015)
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PF582

Ranibizumab biosimilar

(Lucentis)

$3.6B*

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PF582 Biologic Lucentis® marketed by Hoffmann-La Roche and Novartis AG
Global 2015 sales: $3.6 billion*
Used for the treatment of retinal diseases
Released Phase 1b/2a study results in Q3 2016

PF530

Interferon beta-1b biosimilar

(Betaseron)

$0.9B*

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PF530 Biologic Betaseron® marketed by Bayer
Global 2015 sales: $0.9 billion*
Used to treat relapsing multiple sclerosis
Most advanced Betaseron biosimilar in development
Released Phase 1 data in Q1 2016

PF529

Pegfilgrastim biosimilar

(Neulasta)

$4.7B*

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PF529 Biologic Neulasta marketed by Amgen
Global 2015 sales: $4.7 billion*
Used to reduce infections during chemotherapy
Anticipate regulatory feedback by end of 2016

PF688

Certolizumab-pegol biosimilar

(Cimzia)

$1.2B*

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PF688 Biologic Cimzia® marketed by UCB
Global 2015 sales: $1.2 billion*
Used for the treatment of Crohn's disease and rheumatoid arthritis

PF708

Teriparatide therapeutic equivalent candidate

(Forteo)

$1.4B*

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PF708 Innovator drug Forteo® marketed by Eli Lilly
Global 2015 sales: $1.4 billion*
Used for the treatment of high fracture risk osteoporosis
Top-line data from bioequivalence study reported in 2Q16.
Initiation of Immunogenicity/PK study by end of 2016

PF690

Peg-aspargase candidate

(Oncaspar)

$121MM**

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PF690 Biologic Oncaspar marketed by Sigma-Tau
Global 2015 sales: $121MM**
Used for the treatment of Acute Lymphoblastic Leukemia
$11.9
Billion
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Multiple

HemOnc
Products

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Multiple HemOnc Products
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PF444

Human Growth Hormone biosimilar

(Genotropin)

$3.5B***

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PF444 Biologic Genotropin marketed by Pfizer
Global 2015 sales: $3.5 billion***
Used to treat certain growth disorders

PF694

Peg-interferon alpha-2a biosimilar

(Pegasys)

$403MM**

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PF694 Biologic Pegasys marketed by Hoffmann-La Roche
Global 2015 sales: $403 million**
Used for the treatment of chronic hepatitis C
$3.9
Billion

*Based upon publicly available 2015 sales data for the branded pharmaceutical company.
**Approximate 2015 aggregate global branded sales of third-party greference drug per IMS data accessed May 4, 2016.
***Approximate 2015 aggregate global branded sales of third-party growth hormone products per IMS data accessed May 4, 2016.

Last Updated: 9/7/16