Everyone knew this day would come and it has been a long time in coming.  Yesterday, the FDA approved the first interchangeable biosimilar for an insulin product.  An interchangeable biosimilar, like an AB-rated generic product, can be substituted at the pharmacy without intervention of the healthcare provider.

According to the FDA announcement, “Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with (can be substituted for), its reference product Lantus (insulin glargine), a long-acting insulin analog.  Semglee (insulin glargine-yfgn) is the first interchangeable biosimilar product approved in the U.S. for the treatment of diabetes.  Approval of these insulin products can provide patients with additional safe, high-quality, and potentially cost-effective options for treating diabetes.”

We all know the potential for biosimilar products is savings for the consumer.  What we have seen is an (unfortunately) slow but increasing uptake of biosimilar usage; however, now, with the approval of an interchangeable biosimilar, it will be the pharmacies and patients that can make the decision on substitution.  Also, the pharmacy benefits managers (PBMs) will hopefully drive the move to lower cost.  The big questions then obviously becomes how much will consumers save by getting the biosimilar product and will the innovators intercede with the PBMs to blunt substitution with rebates?  Only time will tell!

The FDA originally granted approval for this biosimilar product on June 11, 2020 but approved it as interchangeable on July 7, 2021 to Mylan Pharmaceuticals Inc., according to the FDA’s database, but Mylan is now Viatris and Biocon Biologics Ltd.  To see the full FDA announcement, please click here and the MarketWatch story on the approval can be found here.