With the biosimilar regulatory pathway in sight in markets around the world, companies from the biopharma innovators to traditional small molecule generic houses to well-funded start-ups are exploring how they can enter the biosimilar business. A biosimilar strategy can be either defensive or offensive, depending on the company's position. Countries in Asia, particularly India, Singapore, Korea and China, may be attractive locations to build biodevelopment and biomanufacturing capabilities. The panel, Asia as the Biosimilar Launch Pad, discussed the resources and infrastructure already in place in these countries, what some of the companies are already doing, and how these might impact the biologics markets of United States and Western Europe. The panel provided an overview of the current industry infrastructure, investment incentives and regulatory framework, and key participants in India, Singapore, Korea and China. In addition, speakers profiled examples of companies already building their biologics capabilities in these Asian countries. Finally, the panelists discussed the likely impact on the biologics market of Asia, the United States and Western Europe. The chair was Helen Chen, Partner and Head of China Life Sciences, LEK Consulting, LLC. Panelists included:
The panelists highlighted that Asia can be a launch pad for biosimilars because of one, supportive governments. Many of the countries discussed do not yet have regulatory approval pathways for biosimilars. This can slow down the decision process for approving biosimilars. However, panelists did stress that the countries discussed are supportive of an approval scheme and many will follow the WHO guidelines. Korea released a draft guidance on biosimilars for public review in April 2009, to be finalized in June 2009. This guidance will include a definition of biosimilar and clinical data requirements. Two, Asian countries have a large underserved population. And lastly, these countries have a developed clinical infrastructure. One panelist told the audience that to have a product approved in the United States, a sponsor has to know the serious adverse events. He further hypothesized that success will come to companies that develop a biosimilar that incorporates a new delivery technology. Discussion around interchangeability and data exclusivity were minimal.
Katie McCarthy is the Director of Science and Regulatory Affairs at the Biotechnology Industry Organization