The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs / Research and Development

Drugmakers Seek Clarifications of FDA’s Interchangeability Guidance

May 26, 2017

More drugmakers have weighed in on the FDA’s draft guidance on biosimilar interchangeability, urging the agency to make clear the designation does not mean a product is superior in terms of safety or efficacy.

Apotex, Boehringer Ingelheim, Sandoz, Merck and Coherus requested clarifications to the draft, which calls for clinical switching studies to assess pharmacokinetics and pharmacodynamics.

The amount of data required to support a demonstration of interchangeability depends on factors such as the biosimilar’s complexity and product-specific immunogenicity risks, the FDA said in its guidance.

Both Boehringer and Sandoz, a division of Novartis, asked the agency to make it clear that interchangeability does not involve a higher standard — but simply additional data on a product label. Boehringer added that real-world evidence could be used to support interchangeability approvals, in addition to switching studies.

Merck called on the agency to more clearly define the guidance’s use of the term “standards.”

Coherus also requested further clarification of the draft, asking for definitions for “switching” and “substitution” — concepts that continue to cause confusion and disagreement within the industry.

Coherus also called on the FDA to continue giving sponsors broad leeway to demonstrate interchangeability on a case-by-case basis. In some situations, traditional PK/PD studies may not generate clinically relevant data, so the FDA should be open to alternative study designs in certain circumstances, the company said.

Johnson & Johnson also requested further clarification, noting that while the guidance explains the need for assessments of performance of critical tasks, it lacks a clear definition of “critical tasks.” The firm’s comment recommends adding a sentence to make clear whether these tasks are those dependent on study design or those that are associated with any administration, such as checking expiration dates.

Last month, drugmakers Pfizer and Genentech warned switching studies could become unfeasible. Recruitment would be difficult if the company is required to complete the study solely in the U.S., Pfizer said — while Genentech cautioned that switching studies may be impractical if there is more than one biosimilar on the market.

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