Pfizer Ramps Up Its Biosimilars Business
This article was originally published in The Pink Sheet Daily
Strategy includes launching 10 monoclonal antibodies by 2016 at the earliest
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Merck is gearing up to test the new regulatory pathway for biosimilar drugs in the U.S. and is hoping to be the first drug maker to move a biologic through the abbreviated process, Merck BioVentures President Michael Kamarck said in an interview June 28
In-licensing and development of so-called "bio-betters" will play critical roles in Pfizer's move, announced June 14, into the rare diseases space. The Rare Diseases Research Unit, to be overseen by Jose Carlos Gutierrez-Ramos, senior VP, Biotherapeutics Research and Development, will be part of Pfizer's worldwide R&D unit devoted to discovering novel medicines for orphan diseases, those affecting fewer than 200,000 patients. Initially it will target hemophilia and muscular dystrophy, both caused by genetic mutations
Pfizer's licensing deal with Protalix for global rights to the enzyme replacement therapy taliglucerase for the treatment of Gaucher disease, announced Dec. 1, signals the drug giant's interest in the orphan drug space. It also plays into the company's biosimilar strategy, given that taliglucerase will likely be positioned as a lower-cost alternative to Genzyme's Cerezyme (imiglucerase)