Our Biosimilars

Our Products

Our Products

Pfenex’s protein production platform and bioanalytical approach to developing biosimilars enables the potential for a fingerprint-like identity to a reference product limiting the need for extensive and costly clinical trials. Utilizing our core technology, Pfenex Expression Technology for recombinant protein production, we are able to rapidly develop and produce high-quality therapeutics.

The Pfenex product pipeline currently contains eight biosimilars and one therapeutic equivalent candidate. The 2014 global biologics market represented over $230 billion in product sales with virtually the entire market comprised of branded innovator products. We believe the emerging biosimilar market will be fueled by the large number of blockbuster products facing patent expiry in the next several years, abbreviated regulatory pathways for the approval of biosimilars, and a mandate for lower drug costs by governments and private payers.

Our lead biosimilar candidate is PF582, a biosimilar candidate to Lucentis (ranibizumab). Lucentis, marketed by F. Hoffmann-La Roche and Novartis AG, for the treatment of retinal diseases, achieved approximately $3.6 billion in 2015 global sales.

Our wholly owned candidates include PF530, a biosimilar candidate to Betaseron (interferon beta-1b) marketed by Bayer AG for the treatment of multiple sclerosis that achieved global sales of $0.9 billion in 2015. We are also developing PF708, a therapeutic equivalent to Forteo (teriparatide), for the treatment of high-risk fracture patients. In addition, PF529, a biosimilar candidate to Neulasta (pegfilgrastim), and PF688, a biosimilar candidate to Cimzia (certolizumab-pegol) are also in development.

We also have a product partnership with Strides Acrolab, a specialty pharma company located in Bangalore, India. This includes PF444, a biosimilar candidate to human growth hormone, PF694, a biosimilar candidate to Pegasys (peginterferon alpha-2a), and PF690, a biosimilar candidate to Oncaspar (pegaspargase).

See our complete pipeline of biosimilar candidates below.

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

Jazz_Logo_2-color_Stacked_RGB

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