FDA takes another step to encourage copycat insulin products

The FDA has made another move to allow biosimilars get to market in the US more quickly, this time focused on insulins that currently fall though cracks in its regulatory framework.

At the moment, “chemically synthesised polypeptide” drugs like insulin are excluded from the FDA’s biosimilar or interchangeable product approval pathways, or the framework used for generic drugs as they are classed as biologics.

That means companies looking to develop biosimilars of these off-patent drugs have to file a full marketing application dossier, rather than being able to use the truncated and cheaper pathways available to other drugs.

“In March 2020 most protein products that were approved as drug products (including every insulin currently on the market) will open up to biosimilar and interchangeable competition,” says the FDA, and the current exclusion of polypeptides “could hurt potential competition.”

“Removing this exclusion will help patients because it provides the potential for chemically synthesised follow-on insulins and other protein products to come to market through more efficient abbreviated pathways, regardless of how they are manufactured,” said the agency.

“In addition [it] will help to promote potential innovation in manufacturing methods, which could lead to future efficiencies in manufacturing processes.”

The statement comes at a time when the cost of insulin products is being highlighted by some lawmakers as one area where the pharma industry is exploiting the public, maintaining high prices that can force diabetics to ration their use of the drugs.

It follows new draft guidance published at the end of last month that set out the FDA’s current thinking on the data that should be required for an abbreviated review for an interchangeable insulin product.

That focused in particular on clinical immunogenicity studies that are sometimes needed to make sure that copycat protein drugs made using different manufacturing processes don’t raise the risk of immune reactions.

Prior to the new guidance, the FDA’s position was that immunogenicity studies would be needed as a matter of course, but it is now considering removing that requirement, following the lead of the EMA in Europe which did away with them for biosimilars in guidance published in 2015.

At the moment there are only three approved ‘follow-on’ insulin products in the US, despite the large number of off-patent insulin analogues. Eli Lilly and Boehringer Ingelheim’s Basaglar (insulin glargine) – a version of Sanofi’s Lantus – was the first to reach the market in 2015.

Since then, it has been joined by Merck & Co’s insulin glargine follow-on Lusduna – delayed by litigation and reportedly abandoned by the company last year – as well as Sanofi’s Admelog (insulin lispro), a follow-on version of Lilly’s Humalog brand. Meantime, an insulin glargine product from Mylan has also been held up by a manufacturing issue.

Lilly recently also launched its own generic version of Humalog after being sharply criticised for its pricing policy of the brand.