Biosimilars

Biosimilars

Pfenex Inc. is utilizing its Pfenex Expression Technology to build a comprehensive portfolio of biosimilar protein molecules. Minimal or no advantages are gained by simply repeating an innovator’s protein expression and bioprocess strategy that may have been developed more than 20 years ago. Pfenex applies its parallel processing, toolbox approach to bacterial strain development to arrive at a highly advantaged expression strain and bioprocess. Capitalizing on the cost effectiveness of Pfenex's technology-based processes and the proven ability to rapidly identify a robust production strain, Pfenex is becoming a global leader in biosimilar development.

 

Pfenex currently has nine biosimilar molecules in development. Pfenex’s lead product 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 $4.3 billion is global sales in 2013. The company’s next most advanced product candidate is PF530, a biosimilar candidate to Betaseron (interferon beta-1b) marketed by Bayer AG for the treatment of multiple sclerosis that achieved global sales of $1.4 billion in 2013. In addition, the Pfenex development pipeline includes five other biosimilar product candidates, as well as vaccine, generic and next generation biologic candidates.

 

PF530 is included in a development agreement with Strides Arcolab, a leading pharmaceutical company based in India. In addition to PF530, the Strides Arcolab agreement includes PEGylated interferon beta-1b, PEGylated interferon alpha-2a, PEGylated filgrastim, human growth hormone, and PEGylated aspargase.