Merck Bioventures, a 2 yr old unit in Merck formed to develop biosimilars, formalized a deal with Parexel for its clinical services to bring biosimilars to market quickly. A Merck Bioventures unit will be formed within Parexel as part of the deal.
Merck has two biosimilars under development now - copies of Amgen's Neupogen and Neulasta for the treatment of neutropenia post-chemotherapy in cancer patients. Merck says it plans to have 5 biosimiar drugs in phase III testing by 2012 that it hopes to be able to market by 2015.
Earlier this year, Merck stopped a biosimilar program for a form of Amgen's AraNesp. Merck's version was a PEGylated EPO molecule. The program was stopped when it became apparent that more extensive safety data was going to be required by the FDA.
Merck further indicated that it doesn't plan to rely on its GlycoFi yeast platform to produce the biosimilars as it once had planned but will rely on more standard mammalian cell systems - likely CHO. A Merck spokesman said they expect the FDA to allow for shortened clinical testing with biosimilars but expected the agency to maintain high standards for safety and efficacy of the follow ons.
You can read more in WSJ, Bio Job Blog, and Fierce Biotech in additon to the GEN link above. In addtion to Merck, we also have Pfizer and Novartis (Sandoz) declared in the biosimilar space -- plus Teva, Hospira and Miles and the list keeps growing.
Posted by Bruce Lehr Jan 13th 2011.