Biosimilar insulin companies could face a modestly easier path to market

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Ben Comer Senior Manager, Health Research Institute, PwC US December 06, 2019


The FDA wants to lower the bar on clinical requirements necessary for the approval of biosimilar insulin products beginning in March, according to a new draft guidance document published by the agency.

Starting March 23, if the guidance is finalized, biosimilar insulin manufacturers will not be required to conduct additional immunogenicity studies to receive FDA approval if they use a “comparative analytical assessment based on state-of-the-art technology” that demonstrates that a biosimilar is “highly similar” to the reference product.

In its proposal, the FDA cited advances in manufacturing processes and testing as reasons to allow companies to forgo the immunogenicity studies in certain cases for biosimilar insulin. “This is particularly true of insulin products, which, in contrast to other biologics, are relatively small, structurally uncomplicated proteins that are well-understood and well-characterized,” the agency wrote. The FDA also cited years of experience with these products that have not raised meaningful immunogenicity issues.

Biosimilars developed as “interchangeable,” or able to be substituted for a branded product at the pharmacy without a new prescription, can also skip immunogenicity studies under the proposal, provided they meet the same “highly similar” standard.

Still, some manufacturers may still have to conduct an immunogenicity study if there are uncertainties in an application for approval, such as differences in impurities or novel excipients, the guidance notes. The FDA would make that decision on a case-by-case basis.

HRI impact analysis

Reducing the number of clinical studies needed for insulin biosimilar approval under the biologics 351(k) pathway may stimulate more interest in developing biosimilar insulins, since the costs of conducting the clinical studies required for approval will be lower.

Additionally, more manufacturers may pursue an interchangeable biosimilar approval, a pathway that has been considered too onerous for some, in part because of the immunogenicity study requirements.

The FDA’s decision to remove the requirement of a comparative immunogenicity study for biosimilar insulin approvals is in keeping with the European Medicines Agency’s revised guidance from 2015. Aligning application requirements with European regulators could also make it easier, or less costly, to develop biosimilars eligible for approval in multiple markets.

The US lags behind Europe in the use of biosimilars, which can provide a lower-cost option for patients at a time when insulin prices are repeatedly in the news and discussed on the presidential campaign trail. The House of Representatives has passed legislation that would make it easier to access biologic drug patent information, a boon for biosimilar developers, but the legislation has stalled in the Senate.

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Trine K. Tsouderos

HRI Regulatory Center Leader, PwC US

Tel: +1 (312) 241 3824

Ben Comer

Senior Manager, Health Research Institute, PwC US

Crystal Yednak

Senior Manager, Health Research Institute, PwC US

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