Companies like Pfizer, Teva and Hospira are among the developers trying to get an early jump on the biosimilar drug market. A pathway for biosimilar drugs was approved when the healthcare bill was approved earlier this year, but the FDA has yet to set out clear guidelines for development of the copycat drugs.
But big companies can't resist the call of the potentially lucrative market for generic biologics. Pfizer is set on creating "bio-betters," Hospira is in the process of developing an Epogen biosimilar, and Cipla has inked a number of new deals which will help it build a discount biosimilars franchise. These developers won't have to conduct new trials of their drugs. But they will have to provide data proving that their products are as safe, pure, and effective as the original versions--a requirement that's much more complicated for biologics than it is for pharmaceuticals.
Though the FDA is in the process of laying the groundwork for biosimilar approvals, an FDA spokesperson declined to give Dow Jones specifics about the agency's plans and timing. But as Hospira CSO Sumant Ramachandra notes, those who wait for the FDA's final say on the matter will be behind the ball. "For us to wait may cause us not to be ready when the market opens up...so we need to move now," he explains.
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