FDA guidance finally opens door for insulin biosimilars

New draft guidance from the FDA has opened the door for the development of insulin biosimilars, potentially allowing for cheaper near-identical versions of these biologic drugs to be interchanged with the originator.

The new draft guidance is good news for patients in the US looking for cheaper diabetes medications, and for the biosimilar manufacturers who under current rules can’t compete directly with the more expensive branded drugs.

But it’s bad news for companies like Sanofi and Novo Nordisk, who are already under pressure to cut prices of their branded insulins in the US amid wider scrutiny about prescription drug prices.

It also brings the US in line with the European Medicines Agency, which introduced a biosimilar approval pathway first and has already approved biosimilar insulins.

For example, the FDA did not recognise Eli Lilly/Boehringer Ingelheim’s version of Sanofi’s Lantus (insulin glargine) as a biosimilar, approving it instead as a “follow-on” product that was filed as a new drug.

However the same product was approved as a biosimilar in Europe, allowing it to be interchanged with the originator drug.

The new guidance has other provisions that will help biosimilar manufacturers producing insulins - for instance the FDA had previously required clinical studies evaluating any immunogenicity risks from all insulin-based products.

This would have extended to any insulin biolosimilars under previous thinking, but in this updated guidance the FDA has offered a work-around.

If a comparative analytical assessment based on state-of-the-art technology demonstrates that products are ‘highly similar’, the FDA reasoned that in most cases this would remove almost all uncertainty regarding immunogenicity.

Therefore a clinical immunogenicity study would be unnecessary in most situations, save where candidate products contain certain impurities or novel excipients, for example.

Under the new guidance the FDA recommends a filing for a biosimilar or interchangeable insulin product contains adequate chemistry, manufacturing, and control (CMC) information and a comprehensive and robust comparative analytical assessment between the insulin biosimilar and the reference biological.

Filings must also contain a comparative clinical pharmacology study and an immunogenicity assessment justifying why a comparative clinical study to assess immunogenicity is not necessary.

The FDA is consulting on the draft until 27 January 2020.