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Bio Technology : October 2009
28 Australasian BioTechnology Volume 19 • Number 3 • October 2009 AusBioFEATURE --- AusBiotech 2009 By Vijay Prabhakar, Medical Director, and Dr Pablo Fernandez, Sr VP, Medical Affairs Worldwide, PharmaNet Development Group Global development of biosimilars: opportunities for Asia Pacific The terms 'biosimilar' or 'follow-on biologic' refer to products that are considered to have similar biological properties and therapeutic benefit to an existing biological but are not necessarily identical. The development of biosimilars is more complex than small molecule generics because even though analytical methods for characterisation of biological molecules are being continuously improved, comparing a biosimilar medicine to its innovator counterpart on the basis of these data is still challenging, especially as more complex compounds, such as monoclonal antibodies, become development candidates. It is likely that a program of clinical trials to prove safety and efficacy using clinical endpoints and an adequate number of subjects will continue to be required in most cases. There are significant regulatory and clinical barriers to developing and marketing biosimilars in lucrative markets like the US and Europe where innovator biopharmaceutical companies tend to protect their market-share with complex patents and intellectual property regulations. Even after receiving marketing authorisation, a lack of clarity about product substitution and concerns about immunogenicity could affect the growth of biosimilars. On the other hand, patient forums and health-policy makers advocate market entry of biosimilars to reduce health-care costs and make biosimilars affordable to a larger section of the population. Many patents protecting first-generation biologics are coming to an end in Europe, making the creation of generic versions of these medicines technically possible and the clinical trial community is likely to consider this as an opportunity. Even though developing biosimilars (especially monoclonal antibodies) can require a higher level of skill and investment the profit margins could be higher than traditional generic compounds making them attractive targets for commercialisation. In the long run there is room for both innovators and biosimilars by ultimately expanding the market. Opportunities for Asia Pacific Clinical development of biosimilars provides ample opportunities for biotech companies and clinical service providers in Asia. Thanks to the lower entry barriers, Asian markets have taken a lead in developing biosimilars ahead of the US and Europe. The currently available guidelines in Australia, Taiwan, Malaysia and Japan correspond largely to the European regulatory guidelines for biosimilars. This positions the Asia Pacific region as an attractive destination to develop biosimilars and seek marketing approvals in Asia, Europe and subsequently in the US. By successfully developing biosimilars many Asian companies have demonstrated that regulatory agencies are willing to review their clinical trial applications within established pathways that are comparable to European Union guidelines and investigators are experienced in conducting clinical trials for biosimilars. Table -1 shows the approval status of biosimilars in various leading markets. Of particular interest is the approval of biosimilar monoclonal antibodies in India and Korea, as this class of compounds are still considered too complex for development and are currently subject of intense debate by Western regulatory authorities.[3, 4] Dr Pablo Fernandez Vijay Prabhakar