First biosimilar drug set to enter US market: But such cheaper, generic versions of biological drugs face scientific, regulatory and patent hurdles.
[...] The FDA is expected to make a final decision by May. But even as Sandoz prepares to sell its drug in the United States, it is embroiled in a patent fight with Amgen. By US law, Sandoz had to reveal the details of its manufacturing method to Amgen — a provision not present in Europe — so that Amgen could determine whether any of its patents had been violated. Sandoz refused. That is a disheartening precedent, says Paradise. “Here we’ve got the first biosimilar application and we’ve already got the manufacturers not working together.” “We’ve got the first biosimilar application and we’ve already got the manufacturers not working together.”
Such concerns loom large among manufacturers, says Nicholson Price, a patent-law specialist at the University of New Hampshire School of Law in Concord. Drug firms often keep their manufacturing methods confidential, and production of complex drugs gives them ample opportunity to file patents on manufacturing techniques or ways of characterizing molecules. “The second company is attempting to feel its way in the dark to what the first company has done,” says Price. “I suspect there are other biosimilars that are being deterred either by specific patents or just the worry that there may be patents lurking out there that they don’t know about.” [...]
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biotechnology fda health law policy intellectual property pharmaceuticals regulation