Six biosimilars for 70 emerging markets

CRANBURY, N.J.—Oncobiologics Inc. and Washington, D.C.-basedViropro have signed a biosimilar collaboration agreement under which Viroprowill have the rights to manufacture six monoclonal antibody products beingdeveloped by Oncobiologics for commercialization in more than 70 emergingmarket countries, excluding China. Viropro will have exclusivecommercialization rights to the six biosimilars for Malaysia.

In addition, the companies will co-manage Viropro's Penang,Malaysia-based Alpha Biologics biomanufacturing subsidiary. The two companieswill seek regional partners to drive commercialization. Proximare, a strategicadvisory firm focused on life sciences and healthcare industries, acted asadvisor for the deal. Financial terms were not disclosed.

The six biosimilars are generic versions of Humira, Rituxan,Avastin, Herceptin, Erbitux and one other non-disclosed biotherapeutic. TheOncobiologics website lists only the first four in its current pipeline, andthey are in preclinical testing. Nevertheless, the partnership is planning tolaunch its first product by late 2014. According to company figures, the fivenamed biologics are the most popular therapies in the world for theirrespective cancer and immune disease indications, representing annual globalrevenue of more than $40 billion with more than $6 billion in the emergingcountries covered by the agreement. The companies project that Viropro's commercialand manufacturing royalties have the potential to grow to an annual revenue"run rate" of $60 million to $150 million for Viropro within 10 years.

"The Oncobiologics biosimilars program is a perfectcomplement to Viropro's biomanufacturing expertise. Their scientific team iscomprised of recognized industry veterans, and we are impressed by the highquality of the science they are achieving," says Viropro President and CEOCynthia Ekberg Tsai. "This partnership brings together high-quality moleculesdeveloped to FDA and EU regulatory standards, integrated with world-classbiomanufacturing, the net result being high-quality products with low cost ofgoods. Together, we are well positioned to provide emerging countries access toaffordable, high-quality biopharmaceutical products for critical indications."

Oncobiologics Founder and CEO Dr. Pankaj Mohan adds, "We arethrilled to have Viropro as an anchor partner. Together we form a fullyintegrated biopharmaceutical alliance to serve the emerging markets. Thecombination of a state-of-the-art biologics manufacturing facility and supportfrom the Malaysian government makes Viropro an ideal partner. This uniquepartnership allows us to bring together technical expertise and qualityoversight from the U.S. with a high-capability, low-cost biologics operation inMalaysia."

Dato' Dr. Mohd Nazlee Kamal, CEO of Malaysian BiotechnologyCorp. (Malaysian BiotechCorp), an agency under the Ministry of Science,Technology and Innovation (MOSTI), comments, "Malaysia's strategy to become abiotech hub for Asia is rapidly gaining traction, and thisViropro/Oncobiologics partnership is a significant step in moving this effortforward. BiotechCorp is proud to be part of this collaboration, and we lookforward to many great developments. This project will attract interest in thebiosimilars manufacturing field and will certainly build the confidence ofglobal biotech companies in Malaysian companies as we strive to develop thebiomedical sector in the country." Malaysian BiotechCorp is responsible forexecuting the objectives of the National Biotechnology Policy.

The new alliance's focus on emerging non-Chinese marketsseems destined to raise eyebrows given that the favorable economics ofbiosimilars in such markets can overweigh regulatory concerns at times.

Genentech, which markets its branded versions of Herceptinand Avastin, has published its list of blunt caveats, for example, saying,"With patient safety as a priority, Genentech believes that switching betweenan innovator biologic and a biosimilar presents a potential safety risk topatients (including immunogenicity and loss of efficacy) and should only bedone following demonstration through clinical studies that switching back andforth between the innovator and the biosimilar causes no greater harm thanusing the innovator alone. Biosimilars should be uniquely identified and shouldbe traceable to ensure patient safety, and each claimed indication for abiosimilar should be established by indication-specific clinical trials unlessthere is a solid scientific rationale to justify extrapolation of the clinicalsafety and efficacy data from one indication to another.

Oncobiologics did not respond to questions about the currentstage of development of the six biosimilars specific to the deal, nor did itelect to characterize the governmental and regulatory environments in the 70emerging market countries mentioned in its news release.