The FDA has released long-awaited draft guidelines on the interchangeability of biosimilar products with original brands, and the agency’s message is clear: it won’t be easy winning a biosimilar designation, according to an article posted on the FiercePharma website.
The guidance is intended to assist sponsors in demonstrating that a proposed therapeutic product is interchangeable with a reference product for the purpose of submitting a marketing application or supplement.
Since the mid-1990s, the FDA has approved manufacturing changes for biologic products based on data from comparability assessments. A demonstration of comparability between pre- and postchange product supports a determination that the safety and efficacy profile remains the same for the product.
“With respect to interchangeable products, are there considerations in addition to comparability assessments that [the] FDA should consider in regulating postapproval manufacturing changes of interchangeable products?” the document asks.
Analysts noted that the draft guidelines set a “high bar” to win interchangeability, “most notably requiring [that] switching studies include two exposure periods for each product.”
Interchangeability isn’t required for an approval, the analysts pointed out, as knockoff versions now on the market—such as Novartis’ Zarxio—attest, according to the FiercePharma article. Nor will interchangeability be necessary for commercial adoption. Indeed, pharmacy benefits managers’ 2017 formularies have excluded some originator brands in favor of recently approved biosimilars.
“However, the draft guidance suggests we might be waiting longer before seeing an interchangeable biosimilar come to market,” one analyst pointed out.
The FDA is seeking comment on the draft for 60 days before forming its final interchangeability rules.