Pfenex and Agila Biotech entered into a joint venture to develop, manufacture, and commercialize an initial pipeline of six biosimilar products for the global market. The agreement combines Pfenex’ expertise in strain engineering and process development with Agila Biotech’s strengths in biologics manufacturing and clinical development. The lead product for the joint venture is Interferon beta-1b, a biosimilar to Betaseron®, indicated for relapsing-remitting and secondary-progressive forms of multiple sclerosis. Human clinical trials are expected to begin by Q4 2013.
Pfenex is going to 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 cGMP manufacturing. The joint venture intends to progress the products through Phase III and into commercialization. Manufacture of the collaboration products will be carried out at Agila Biotech’s manufacturing facility being built with Bio-XCell at Nusajaya, Johor, Malaysia.
“One of the global challenges for the future of healthcare is to develop and produce products within the confines of a constrained cost environment,” said Bertrand Liang, M.D., Ph.D., CEO at Pfenex. “Biosimilars are and will play an increasingly important role in patient disease management. This venture between Pfenex and Agila Biotech will allow us to leverage our infrastructure for the development of safe, reliable, and cost-effective therapies for patients to address unmet medical needs all over the world.”
“Successful forays into the biologics space for companies like Agila Biotech would hinge not only on building an infrastructure and strong technical foundation, but also on creative partnerships such as the one that Agila Biotech has entered into with Pfenex. This will allow us to not only leverage time and cost advantage of developing products in India and Malaysia, but also serve as a gateway to a vast region in South Asia, South-East Asia, and the OIC region currently underserved as a result of the lack of high-quality, cost-effective biologics,” said Anand Iyer, CEO at Agila Biotech.
Markets and Markets estimates that the global biosimilars market will total $19.4 billion by next year.