Biotech Values

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FORBES - Novartis Exec: Golden Age Of Generic Biotech Drugs Is Coming - July 26

The FDA's surprise approval of Novartis' generic version of the blood thinner Lovenox after a four-year review is a signal the FDA may be more willing to approve complex generic products in the coming years, says Jeffrey George, global head of Novartis's Sandoz generic drug unit.

"It underscores that the FDA really does have the institutional courage to approve affordable high quality alternatives to some of the more difficult to make products that are out there. There were a lot of interests lined up against this approval," George said in an interview on July 22. "It bodes well for the approval of more complex generic products in the future."

George says that starting in the years 2015 and 2016 numerous biotech products will start losing patent protection, including monoclonal antibody drugs that are used to treat cancer and autoimmune disease. "Biologic medicine is a $100 billion industry. There is a lot of savings to be had." Two longstanding and obvious targets for generic drug makers are Epogen and Neupogen from Amgen.

While Lovenox, made by Sanofi-Aventis, is not a protein drug, it is a very complex drug made from sugars that is hard to copy. Proving you have an identical copy is difficult. George says that partner Momenta Pharmaceuticals technical abilities in characterizing complex sugar molecules was key to getting the approval. Momenta's technology "is highly differentiated and certainly played a significant role." The two companies also have a partnership on making a generic version of Teva's multiple sclerosis drug.

George said that the timing of the FDA approval, after a four-year review was a surprise as much to him as everybody else."The FDA doesn't give you a sense when this is coming. We found out at the same time as everybody else did--when we got the approval," he says, adding: "To get this on my last day of work before vacation is a nice piece of news.

http://blogs.forbes.com/sciencebiz/