The companies will develop, manufacture and commercialize an initial pipeline of six biosimilar products for the global market. They identified their first target as a biosimilar of multiple sclerosis treatment Betaseron (interferon beta-1b), which they expect to be in human clinical trials by Q4 2013.

Pfenex will assume primary responsibility for development of an optimized production strain, process and analytical package for each product, while Agila Biotech will be responsible for preclinical and phase I development, as well as manufacturing, according to good manufacturing practice requirements. The joint venture will then progress the products through phase III and into commercialization. Manufacture of the collaboration products will be carried out at Agila Biotech’s state-of-the-art manufacturing facility being built with Bio-XCell in Malaysia.

Manufacturing the biosimilars in Malaysia was seen to not only be cheaper, but also provide a gateway for high quality, cost-effective biologicals into Asia and the Organisation of Islamic Cooperation (OIC) region, which are currently underserved.

This is not the first biosimilars collaboration that Pfenex has entered into. Back in 2010 the company made an agreement with Ranbaxy Laboratories to develop an undisclosed biosimilar using the company’s Pfenex Expression Technology platform, a pseudomonas-based recombinant protein expression technology.

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