In the latest development in the biosimilars market, in September, the European Medicines Agency granted its first approval for a monoclonal antibody biosimilar. IMS Health estimates that biosimilar sales in markets that are highly regulated totaled around $700 million in 2011 and will account for about 2% of the total biotech market by 2016. According to the Biotechnology Information Institute, there are 560 biosimilars in development aimed at replacing 120 existing biologics. Thirty-four biosimilars alone are in development for Rituxan, and thirty are being developed for Herceptin. In Asia, the US and Europe, there are 97, 62 and 50 biosimilar developers, respectively. Many biosimilars are being developed via partnerships, as smaller companies seek to enter more regulated markets by partnering with established companies, or biotech firms are partnering with generic companies to gain expertise. Amgen and Pfizer are among the companies that make both branded biologics and biosimilars. Due to complex regulatory and manufacturing requirements, including the requirement for an exhaustive analysis of the originator product, a biosimilar can take as many as eight years to develop at a cost of $250 million.

Source: Chemical & Engineering News