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NEW YORK —Biosimilars, biogenerics, follow-on biologics—whatever the designation one prefers for knockoffs of biotech drugs—they will soon become a part of the American healthcare system.
The healthcare-reform bill contained a provision creating an abbreviated regulatory approval pathway for follow-on biologics—albeit one that requires the Food and Drug Administration to wait until the innovator biologic has been on the market for 12 years before approving the follow-on version, rather than the five-year market exclusivity period used for generic pharmaceutical drugs.
Of particular interest is the case of Lovenox (enoxaparin sodium), a form of the blood thinner heparin, and the marketing of a generic version by Sandoz, which manufactures the drug under a partnership with Momenta Pharmaceuticals. Sandoz, the generics division of Swiss drug maker Novartis, won approval from the FDA to market generic Lovenox in July, and Sanofi sued to halt Sandoz, saying the FDA had acted improperly in granting approval, but a federal judge ruled in favor of Sandoz and the FDA. The catch is that though Lovenox received FDA approval in March 1993 as a pharmaceutical, many experts consider it a biologic due to its chemical complexity, and the FDA required testing for potential issues like allergic reactions before it would approve the generic version. For that reason, many experts said, the case of generic Lovenox could have a major influence on the regulatory approval process for follow-on biologics.
But after the market does take shape, it could eventually look increasingly more like the generic drug market, director Michael Malecki of industry research firm Decision Resources told Drug Store News. Malecki expected follow-on biologics’ initial effect on pricing to be small, at least until biosimilar monoclonal antibodies begin reaching the U.S. market, but that the market will take off over the next decade. “Over the next 10 or so years, we will be seeing a lot of marketing on the part of branded and biosimilar companies trying to shape the landscape,” Malecki said. “Biosimilar companies will claim that their products are just as safe and effective as brands, and some brands will try to counter that argument.”
In around 20 years, Malecki said, biosimilars could be as uncontroversial as generic drugs. “At some point in the future, biosimilars will be regarded analogously to small-molecule generics,” he said. “The questions are how long that change will take and what will be the ‘shape of the curve’ between now and then.”
In the meantime, some companies aren’t waiting and are seeking approval for biosimilars under the normal approval process. In February, for example, the FDA accepted Teva Pharmaceutical Industries’ application for XM02, a biosimilar of Amgen’s Neupogen (filgrastim) that it already markets in Europe under the name TevaGrastim. Teva is seeking approval for the drug as a treatment for lowered counts of white blood cells called neutrophils, also known as febrile neutropenia, in patients receiving chemotherapy.