Semglee becomes first biosimilar to gain interchangeability designation –A critical milestone

July 29, 20210

In a critical milestone for the biopharma and patient fraternity, US FDA grants the first interchangeability designation to Semglee, biosimilar insulin glargine co-developed and marketed by Biocon and Mylan. Semglee is now both biosimilar to and interchangeable with its reference biologic Lantus (insulin glargine) by Sanofi. It is indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Semglee was approved in June 2020 and was subsequently launched in September 2020 by Biocon and Mylan at a steep 65% discount to Lantus’ list price. At the time of launch, the duo had indicated that they are seeking interchangeability designation for the biosimilar in order to ensure broader access to affordable insulin products.  

The approval comes as a landmark decision for millions of diabetes patients that rely daily on insulin treatment. Interchangeability designation essentially renders the biosimilar substitutable at the pharmacy without a physician’s prescription, just like a generic drug. Hence, it allows patients to opt-for lower-cost, safe and effective versions of insulin and substantially reduces healthcare costs.  

The US FDA’s decision comes at a time when insulin prices have been the centre of debate in patient rights groups and both the Federal Government and the US FDA have undertaken progressive measures in the last one year to improve the access, affordability and introduction of new biosimilar products in the market to encourage competition and better patient access. To this end, the US FDA updated the Purple Book to be more transparent with respect to patent and exclusivity information and the US Senate passed a bill to create educational resources for biosimilar products to promote adoption by physicians and patients. Interchangeability of biosimilars has been under consideration of US FDA for a long-time now and multiple biosimilar developers have already started conducting interchangeability clinical studies for the future pipeline of biosimilars which include Celltrion pushing for Inflectra’s (infliximab biosimilar) interchangeability and Boehringer Ingelheim for its adalimumab biosimilar Cyltezo.  

This development is momentous for biosimilar developers across the world with an established precedence of an interchangeable biosimilar now and confidence by the US FDA in approving interchangeable biosimilars. It is also remarkable to note that the interchangeability approval comes to a biosimilar co-developed by an Indian company Biocon and sets an example of the progress the biopharma industry has made over the decades in both developed and emerging markets.  

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