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Last Updated : Dec 03, 2019 08:53 PM IST | Source:

USFDA's new draft guidelines on insulin products to help biosimilar makers like Biocon

Once insulins are regulated as biologics or biosimilars, it will become possible for drug companies to seek interchangeable designations for their products.

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The new draft guidelines issued by the USFDA to help facilitate the development of insulin products is expected to give a boost to companies like Biocon who are trying to crack the lucrative US insulin market.

So far, US-approved insulins are approved as “follow-on” drugs under Section 505(b)(2) pathway of the Food, Drug, and Cosmetic Act. But from March 2020 onwards, insulin products will be approved as biologics under the Biologics License Applications (BLA) pathway.

Once insulins are regulated as biologics or biosimilars, it will become possible for drug companies to seek interchangeable designations for their products.


For instance, Basaglar (a biosimilar of Sanofi’s basal insulin Lantus), sold by the Eli Lilly-Boehringer Ingelheim duo, is classified in the US as a “follow-on” drug. This makes it ineligible for interchange with Lantus.

The same Basaglar is approved in Europe under the biosimilar pathway, thus making it eligible for substitution.

This has resulted in higher-priced insulins for diabetes patients in the US, as Sanofi and Novo Nordisk had a stranglehold on the market.

The USFDA, in its draft guidelines, also proposed the waiver of a comparative clinical immunogenicity study, in certain conditions for approval of 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 or not the therapy will work well and be safe.

“This draft guidance is intended to help guide efficient product development by clarifying what data and information may – or may not – be needed to support a demonstration of biosimilarity or interchangeability for a proposed insulin product, as defined in the draft guidance,” USFDA said in a release.

“The FDA is committed to continuing our efforts to help increase market competition among insulin products, which may potentially lower costs for patients and payors and increase access and product choice,” the agency added.

Companies like Biocon, which are engaged in biosimilar development, have welcomed the development.

“We welcome the decision of USFDA and believe it is a step in the right direction,” said Biocon Biologics spokesperson.

“It will help companies like Biocon Biologics to take its high quality affordable Rhi and analogue insulins in its pipeline to the patients in the US faster. Biocon Biologics has been working with various stakeholders to enable this decision in the best interest of patients,” the spokesperson added.

Biocon had filed for the insulin glargine in the US under Section 505(b)(2) pathway.  The approval is still pending. It is still unknown whether the company will have to shift to the BLA pathway, if its insulin glargine doesn't get approval before March 23, 2020.

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First Published on Dec 3, 2019 08:42 pm
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