Regulatory experts see huge challenges on biosimilar rules

Even as European regulators are laying out new rules to govern the development of a new generation of biosimilars, some experts in the U.S. are wondering how the FDA can begin to manage the construction of such a complex approval pathway--particularly in light of continued sniping from lawmakers as well as industry players.

Speaking on a Brookings Institution panel, consultant Mary Pendergast told the audience that developing an actual match for a biologic over the course of its 12 years of patent protection is a perplexing task, particularly when you consider that the product can be changed during the manufacturing process.

"If you have a pioneer in year 12 that has a product different from the biologic that was tested for a biosimilar in year two or three, at year 12, are they going to be biosimilar or not?" she said, according to a report in The Hill. And how can regulators fashion new regulations when they continue to get conflicting feedback from lawmakers and the industry?

"Members of Congress have already told the FDA what they think they should do, which may or may not be identical to law as written," Pendergast said. "The FDA will be under pressure from the innovator and biosmilar industries one way or another. This is very difficult to the FDA."

- here's the report from The Hill

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