Europe may be old, but it's way ahead of the New World when it comes to biotech generics. Novartis just got E.U. approval for its third biosimilar drug: Neupogen, a.k.a. filgrastim, a neutropenia treatment often used in chemo patients and bone-marrow transplant recipients.
The Neupogen copy, a protein produced via recombinant DNA technology, is made by Sandoz, Novartis' generics unit. As you know, copycat versions of biotech drugs aren't precisely identical to their original counterparts, but similar enough to work the same way. Sandoz got its first biosimilar approval in 2006, for the human growth hormone Omnitrope (it also happened to be the first-ever biosimilar in the E.U.). Then, in 2007, the company got the nod for its follow-on erythropoetin med, Binocrit/Epoetin alfa Hexal.
The U.S., of course, has yet to put in place a framework for approving copycat versions of biotech meds. Congress aims to create one, but it's caught in the wrangling between branded drugmakers and generics firms. The biotech industry wants 12 years of market exclusivity, but the generics industry prefers the old pharma model of five years' exclusivity plus patent protection. In Europe, biotech meds get 11 years' solo flight, the Associated Press reports.
Anticipating that some sort of pathway will be forged soon, U.S. drugmakers are gearing up to get into the biosimilars biz. Merck announced its intent to tackle the market last year, and just yesterday said it plans to buy a Colorado biosimilars operation to jump-start its efforts.