Semglee was approved under the FDA’s 351(k) pathway, a biologics license application process. It ensures that the bio similarity is based on animal studies, clinical trials, and analytical studies.
The U.S. Food and Drug Administration (FDA) approved Viatris and Biocon Biologics’ Semglee (insulin glargine-yfgn injection), which they’re calling the first interchangeable biosimilar product.
A biosimilar is a generic version of a biologic drug. Unlike a generic, which is typically an exact copycat, biosimilars are similar to the branded drug, which means they typically have to undergo a clinical trial process. Semglee is a biosimilar for the reference drug, Sanofi’s Lantus, long-acting insulin to treat adults with type 2 diabetes and adults and pediatric patients (children six years and older) with type 1 diabetes. It is sold in a pre-filled disposable pen. Semglee is not indicated for diabetic ketoacidosis. It has an identical amino acid sequence to Lantus.
Semglee was approved under the FDA’s 351(k) pathway, which is a biologics license application process. It ensures that the bio similarity is fully based on data associated with animal studies, clinical trials and analytical studies.
“We are extremely proud to achieve the industry’s first approval of an interchangeable biosimilar product in the U.S., which will help broaden access to this important diabetes medicine for patients, physicians, payers and providers,” said Michael Goettler, chief executive officer of Viatris.
The companies expect Semglee to hit the market before the end of the year. They are also eligible for 12 months’ exclusivity before the FDA can approve another biosimilar that is interchangeable with Lantus.
The companies’ insulin glargine has been approved in more than 60 countries and is the third one the FDA approved that comes out of the Viatris-Biocon Biologics collaboration.
The approval allows for “pharmacy-level substitution,” meaning that the pharmacy can make the switch if the prescription is for Lantus, although the laws that oversee that swap vary by state.
Viatris has exclusive commercialization rights in the U.S., Canada, Australia, New Zealand, the European Union and European Free Trade Association countries. Biocon Biologics has exclusive commercialization rights for Japan and specific emerging markets. The two companies have co-exclusive commercialization rights to the rest of the world.
“This is a momentous day for people who rely daily on insulin for the treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce health care costs,” said Janet Woodcock, acting commissioner of the FDA.
In August 2020, Biocon Biologics and Mylan, which is now Viatris, launched Semglee in the U.S. However, it didn’t have interchangeable status at that time because the approval didn’t fall under the biosimilar pathway in the Biologics Price Competition and Innovation Act (BPCIA). They hope the new approval will support its acceptance and use across the health care community, and potentially decrease the cost of insulin.
Rajiv Malik, president of Viatris, stated, “We are very pleased to have once again worked with the FDA to achieve the very historic approval of the first interchangeable biosimilar in the U.S. and are grateful to our partner, Biocon Biologics, for their collaboration in achieving this milestone. Our continued ability to break down barriers to access, bring forth first-to-market products and blaze new trails is a testament to the strength of our scientific, regulatory, operations and legal expertise as well as our focus on patients.”
