Today’s Top 10 list: follow-on biologics developers/marketers
With legislation possibly creating a regulatory pathway for follow-on biologics (biosimilars, generic biologics, biogenerics, et al.) in the US as early as 2009 (but more probably later), I figured it’s time to break out the for-no-good-reason top-10 list of major players in this coming market and their first likely drugs approved. I guarantee that at least one of these top 10 companies might or might not surprise you. Heed my words, or buy a 2-year old $7600 report on the topic from Datamonitor–your choice.
In no particular order:
- Novartis (Sandoz/Hexal) – GH, Epoetin alfa
- Pfizer
- Teva/Sicor – G-CSF
- Hospira/Mayne – Epoetin alfa
- Dr. Reddy’s – Anti-CD20 (Rituxan), G-CSF
- Matrix Laboratories/Mylan – TBD
- Biocon – G-CSF, Epoetin alfa, Streptokinase
- Ranbaxy/Daiichi Sankyo
- Merck (US) – TBD (Surprised? I was.)
- Cangene – GH, GM-CSF
Note the presence of several India-based companies. Some of these, e.g. Biocon, will likely partner with US distributors rather than attempt to go it alone. Other Indian firms, like Shantha and Bhata will undoubtedly be manufacturers of FOBs for the US market. Also, I would look for other major pharmas to announce their intention to be major players in this space. Smaller US and non-US firms will have signifcant trouble competing heads-on with the major generics and pharmas for bona fide FOBs, given the technical and commercial hurdles facing the category. However, there will be ample opportunity for companies of all sizes to prosper in the biologics improvement space, a category we will hear much more from in the next decade.
