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Six biosimilars for 70 emerging markets
CRANBURY, N.J.—Oncobiologics Inc. and Washington, D.C.-based Viropro have signed a biosimilar collaboration agreement under which Viropro will have the rights to manufacture six monoclonal antibody products being developed by Oncobiologics for commercialization in more than 70 emerging market countries, excluding China. Viropro will have exclusive commercialization 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 companies will seek regional partners to drive commercialization. Proximare, a strategic advisory firm focused on life sciences and healthcare industries, acted as advisor 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. The Oncobiologics website lists only the first four in its current pipeline, and they are in preclinical testing. Nevertheless, the partnership is planning to launch its first product by late 2014. According to company figures, the five named biologics are the most popular therapies in the world for their respective cancer and immune disease indications, representing annual global revenue of more than $40 billion with more than $6 billion in the emerging countries covered by the agreement. The companies project that Viropro's commercial and 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 perfect complement to Viropro's biomanufacturing expertise. Their scientific team is comprised of recognized industry veterans, and we are impressed by the high quality of the science they are achieving," says Viropro President and CEO Cynthia Ekberg Tsai. "This partnership brings together high-quality molecules developed to FDA and EU regulatory standards, integrated with world-class biomanufacturing, the net result being high-quality products with low cost of goods. Together, we are well positioned to provide emerging countries access to affordable, high-quality biopharmaceutical products for critical indications."
Oncobiologics Founder and CEO Dr. Pankaj Mohan adds, "We are thrilled to have Viropro as an anchor partner. Together we form a fully integrated biopharmaceutical alliance to serve the emerging markets. The combination of a state-of-the-art biologics manufacturing facility and support from the Malaysian government makes Viropro an ideal partner. This unique partnership allows us to bring together technical expertise and quality oversight from the U.S. with a high-capability, low-cost biologics operation in Malaysia."
Dato' Dr. Mohd Nazlee Kamal, CEO of Malaysian Biotechnology Corp. (Malaysian BiotechCorp), an agency under the Ministry of Science, Technology and Innovation (MOSTI), comments, "Malaysia's strategy to become a biotech hub for Asia is rapidly gaining traction, and this Viropro/Oncobiologics partnership is a significant step in moving this effort forward. BiotechCorp is proud to be part of this collaboration, and we look forward to many great developments. This project will attract interest in the biosimilars manufacturing field and will certainly build the confidence of global biotech companies in Malaysian companies as we strive to develop the biomedical sector in the country." Malaysian BiotechCorp is responsible for executing the objectives of the National Biotechnology Policy.
The new alliance's focus on emerging non-Chinese markets seems destined to raise eyebrows given that the favorable economics of biosimilars in such markets can overweigh regulatory concerns at times.
Genentech, which markets its branded versions of Herceptin and Avastin, has published its list of blunt caveats, for example, saying, "With patient safety as a priority, Genentech believes that switching between an innovator biologic and a biosimilar presents a potential safety risk to patients (including immunogenicity and loss of efficacy) and should only be done following demonstration through clinical studies that switching back and forth between the innovator and the biosimilar causes no greater harm than using the innovator alone. Biosimilars should be uniquely identified and should be traceable to ensure patient safety, and each claimed indication for a biosimilar should be established by indication-specific clinical trials unless there is a solid scientific rationale to justify extrapolation of the clinical safety and efficacy data from one indication to another.
Oncobiologics did not respond to questions about the current stage of development of the six biosimilars specific to the deal, nor did it elect to characterize the governmental and regulatory environments in the 70 emerging market countries mentioned in its news release.