Thomas Reuters recently updated a white paper they issued back in 2011 on the US biosimilar market. In it they describe the current regulatory policy as they see it and its effect to date on slowing down the introduction of US biosimilars. See Lonza announcement this morning for confirmation of that.
But overall, I see the white paper as being generally bullish on the idea that biosimilars will be successfully launched in the US -- but initial entrants will most certainly be experienced, well-resourced orgainzations. By Reuters reckoning, the top players in the US market will be companies like Sandoz (Novartis' generics arm), Hospira, Teva and Amgen/Actavis partnership. All 4 companies have leading positions within generics markets and lots of experience dealing with FDA and marketing the products. Other companies that could be players in relative short-term -- include the likes of Samsung/Merck, Pfizer, Celltrion and Boehringer Ingelheim.
Of course outside the US markets, especially in the lesser regulated markets, all of the above competitors will be prevalent but may be joined by companies like Reliance, Dr. Reddy's and Biocon/Mylan partners among other strong local competitors in places like China.
Check out the updated report - Download AnOutlookOnUSBiosimilarCompetition-cwp-en
Posted by Bruce Lehr July 25th 2013.