PhRMA has weighed in with its comments to the FDA guidelines on biosimilars. In those, the trade group says that the FDA should not allow biosimilar manufacturers potential flexibility in delivery devices and formulations -- and still regulate it as a biosimilar.
PhRMA speaks out against FDA biosimilar flexibility.
A spokesman for PhRMA said, "Intentionally introducing differences to the molecule or the finished product will increase the level of uncertainty regarding the proposed biosimilar's similarity to the reference product. The statute imposes a scientifically rigorous standard that each product must be highly similar to its reference product. Statutory considerations therefore cousel that FDA guidance should recommend that applicants minimize controllable process and design differences."
Several Big Pharma and BIO have weighed in with similar comments.
Posted by Bruce Lehr Apr 30th 2012
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