Industry Seeks Clarity on FDA’s Biosimilars Q&A Draft Guidance

Drugmakers want the FDA to clarify when data on non-U.S.-licensed biologicals can be used to support a biosimilar application.

The Biologics Price Competition and Innovation Act mandates that biosimilars must be assessed against a single reference product licensed in the U.S., PhRMA and BIO note in comments to the FDA, which means a foreign reference product can’t be used.

But in draft Q&A guidance issued earlier this year, the FDA suggests a sponsor may use data from a clinical study comparing its proposed biosimilar to a non-U.S.-licensed product to support FDA approval in certain circumstances. In such cases, the foreign comparator would be considered an investigational drug and would require an IND for importation and use, the guidance says.

Abbott argues that while the BCPIA allows sponsors to submit information about additional foreign-licensed biological products, it precludes using that information as the reference product. PhRMA agrees, saying foreign data should be used only to corroborate the pivotal data comparing the biosimilar with the FDA-approved reference product.

BIO says that while it supports the use of bridging data, comparative trials involving foreign products made by firms that don’t hold the U.S. license should not be accepted.The three were among 50 industry groups, drugmakers and other stakeholders that commented on the draft.

BIO also says biosimilars makers should have to verify that design differences in a biosimilar’s delivery device or closure system won’t impact its safety and effectiveness, compared with the reference product. For interchangeable biosimilars, the FDA should insist that the delivery device and container closure system are identical, the group adds.

Biosimilars that treat fewer conditions than their reference product should be clearly labeled as such to avoid confusion or misuse, BIO says. PhRMA wants the FDA to ensure that the name on a biosimilar’s labeling and packaging differentiates it from the reference product and other biosimilars.

Industry also wants clarification on when a polypeptide should be considered a protein.

The FDA should define “protein” and “chemically synthesized polypeptide” based on science and manufacturing methods, PhRMA says. Novo Nordisk says the definition of protein should reflect a product’s primary method of manufacture and not its size.

The FDA also needs to explain what will happen if a reference biologic is approved for a new indication after a biosimilar has been approved and how long sponsors should retain samples used in 351(k) applications, BIO says.

PhRMA and Abbott want the FDA to clarify its “first licensure” provision, which grants 12-year exclusivity to supplements and certain subsequent applications, saying a reference to “other related entity” is unclear.

The draft guidance was released in May. View it at — Kellen Owings




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