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.
