Negotiating the Emerging Biosimilars Landscape: Key developments in the regulatory environment
As regulatory obstacles to biosimilars development have become increasingly resolved, a growing number of opportunities have been created for generics companies in the biopharmaceutical market, which according to IMS data was valued at $85.9 billion in 2007. Conservative projections estimate that sales of biopharmaceutical products will exceed $135 billion by 2011.
With some of the earliest biopharmaceuticals having already lost patent protection, the originators of biopharmaceutical products are facing intense competition from generics developers. In response, originators are resorting to a range of defensive tactics, including the reformulation of existing products to improve efficacy, the implementation of more efficient delivery systems and the pursuit of high-level intellectual property (IP) battles.
