FDA draft guidance aims to facilitate biosimilar insulin development
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The FDA on Monday announced new draft guidance designed to help facilitate the development of insulin products for people with type 1 and type 2 diabetes, part of a broader effort to increase market competition, lower costs for patients and payors and increase access and product choice.
According to an agency press release, the draft guidance is intended to help guide efficient product development by clarifying what data and information may or may not be needed to support a demonstration of biosimilarity or interchangeability for a proposed insulin product, as defined in the draft guidance.
“The draft guidance reflects, among other things, the FDA’s decades of experience with insulin products which, along with wide clinical use, has contributed to a robust scientific understanding of these products,” the agency stated in the release. “The draft guidance also reflects consideration of stakeholder feedback provided at the FDA’s May 2019 public hearing on this topic, at which stakeholders were invited to provide input on developing biosimilar and interchangeable insulin products.”
New FDA draft guidance is designed to facilitate development of insulin products for people with diabetes, part of a broader effort to increase market competition, lower costs for patients and payors and increase access and product choice.
There are currently two biosimilar insulins approved in the U.S. — Basaglar (Lilly), a follow-on to insulin glargine (Lantus, Sanofi) approved in 2015, and Admelog (Sanofi), a follow-on to insulin lispro (Humalog, Lilly) approved in 2017.
More efficient development
The FDA recommends in the draft guidance that, under certain circumstances, a comparative clinical immunogenicity study would not be necessary for approval of certain proposed biosimilar and interchangeable insulin products. In general, immunogenicity studies investigate the presence of an immune response to the therapeutic protein and its clinical impact, which can influence whether the therapy will work well and be safe.
“In the circumstances described in the draft guidance, the FDA generally expects the risk of clinical impact from immunogenicity to be minimal for certain proposed biosimilar and interchangeable insulin products,” the agency stated in the release. “As such, while applications for biosimilar and interchangeable insulin products would be expected to include an immunogenicity assessment, that assessment could include a scientific justification of why a comparative clinical study to assess immunogenicity is not necessary for that particular proposed insulin product.”
The recommendations described in the draft guidance may result in a more efficient development program that could ultimately bring biosimilar or interchangeable insulin products to the market more quickly, the agency said.
Applications for proposed biosimilar or interchangeable insulin products need to meet strict statutory standards, and applicants will need to submit data and information sufficient to demonstrate biosimilarity or interchangeability, including, among other things, a comparative clinical pharmacology study adequate chemistry, manufacturing and controls information and a comprehensive and robust comparative analytical assessment.
FDA noted that, for some proposed biosimilar or interchangeable insulin products, a comparative clinical immunogenicity study may still be needed to address residual uncertainty regarding immunogenicity.
“For example, a comparative clinical immunogenicity study may be needed if there are differences in certain impurities or novel excipients, but that would be a case-by-case scientific determination in the context of individual applications,” the FDA wrote.
New pathway
The draft guidance supports key goals in the agency’s Biosimilars Action Plan, which aims to improve the efficiency of the biosimilar and interchangeable product development and approval process and to maximize scientific and regulatory clarity for the biosimilar product development community. As Endocrine Today previously reported, the FDA released guidance documents in December 2018 outlining a new pathway for biologic products to promote competition and lower prices for drugs with historically high list prices, including insulin and human growth hormone. Starting March 23, 2020, the approved marketing applications for a small subset of “biological products” such as insulin and human GH — currently approved as drugs under section 505 of the FDA’s Federal Food, Drug, and Cosmetic Act — will be deemed to be biologics licenses under section 351 of the Public Health Service Act.
“The FDA is working now, in advance of the March 23, 2020 transition, to build a solid regulatory foundation for the review and approval of biosimilar and interchangeable insulin products,” the agency stated in the release.
The FDA will begin accepting comments from the public on the draft guidance on Friday. – by Regina Schaffer
Reference :
FDA. Clinical immunogenicity considerations for biosimilar and interchangeable insulin products. Available at: https://www.fda.gov/media/133014/download.
FDA. Biosimilars action plan. Available at: https://www.fda.gov/media/114574/download.
Disclosures: The authors report no relevant financial disclosures.