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15 August 2014Americas

PhRMA reacts to FDA’s biosimilars guidance

The Pharmaceutical Research and Manufacturers of America (PhRMA) has voiced concerns about the US Food and Drug Administration’s (FDA’s) draft guidance on biosimilars, which it suggests if enacted, could have an impact on the safety of biosimilar products.

In May, the FDA released  Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product, which was intended to help drug makers design their clinical pharmacology studies, which demonstrate how similar a biological product is to its reference product.

It created four categories to help quantify the similarity of two biological products that can be used to determine whether further clinical studies need to be undertaken. The categories are “not similar”, “similar”, “highly similar”, and “highly similar with fingerprint-like similarity”.

In its letter dated August 12, PhRMA called this hierarchy “beyond the scope of the draft guidance”, and said that the relationship between the two latter categories is unclear. It suggested that the FDA remove the four-tiered framework and, if it does not, “substantially revise” it as it finds the definitions of the four categories to be “vague and confusing”.

“In particular, PhRMA suggests that FDA clarify the meaning of the new ‘similar’ category, which could be interpreted by some as being inconsistent with the [Biologic Price Competition and Innovation Act]’s requirement,” it said in the letter.

PhRMA also asks the FDA to clarify when it believes clinical pharmacology data is “sufficient to demonstrate that a proposed biosimilar has no clinically meaningful differences in safety, purity, and potency from the reference product,” as well as the content on safety and immunogenicity studies.

In the guidance, the FDA said that safety and immunogenicity data derived from clinical pharmacology studies may need to be supplemented by additional evaluations, either before or after the product has been approved, but PhRMA says that, in order to protect patient safety, a premarket evaluation of safety and immunogenicity is “essential”.

“The FDA’s standards for accepting clinical pharmacology data can have serious implications for patient safety, as well as the purity and potency of biosimilar products,” PhRMA said.

“PhRMA hopes that FDA will continue to seek stakeholder input openly and transparently as it implements the BPCIA.”


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