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FDA holds hearings on the path to biosimilars

Monday, November 1st, 2010



Federal drug regulators are set to hear from two factions in the pharmaceutical industry this week.

In coming years, the U.S. Food and Drug Administration will decide what kind of regulatory obstacles drug makers must scale to bring biosimilar therapies to market. This week, the is agency is holding public meetings.

Right now, medical therapies called biologics come only in brand-name form. Different from pharmaceuticals made from chemicals, biologic therapies are grown from living organisms.

Christopher Molineaux leads the life sciences trade group Pennsylvania Bio.

Molineaux: The two sides really are the innovator companies, companies like Johnson and Johnson, GlaxoSmithKline, Merck, Pfizer. Those are companies that innovate and create the original biotech drug, and on the other side of course are the generics companies, companies like Teva, also here in Pennsylvania, that are looking to bring a less expensive version of the product to patients.

Molineaux says the upfront investment in biologics is very costly and it’s unclear if biosimilar products will be significantly cheaper.

Molineaux: The federal health law allows for 12 years of data exclusivity, which really says to the innovator company that they have 12 years of protection to recoup their research and development costs before a generic company can try to come out with a biosimilar product that would compete with the innovator.

Experts say the complicated, and expensive processes that bring biologics to market will be hard to replicate exactly, so federal regulators will surely want to build in safeguards to insure that the biosimilar drugs are effective and safe.


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