Mylan And Biocon’s Semglee Insulin Glargine Approved In US
Product Deemed A Biologic By FDA; Launch May Be Imminent
Mylan and Biocon have received FDA approval for their Semglee insulin glargine product, with a path to market seemingly clear after Mylan emerged victorious in several recent patent-litigation challenges. Meanwhile, the firm continues to strive towards an interchangeability designation that would make it a much more valuable opportunity.
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Viatris has revealed its commercial strategy for its Semglee insulin glargine biosimilar in the US after winning a landmark first designation of interchangeability for the product from the FDA that will allow pharmacy-level substitution with a year of exclusivity.
AmerisourceBergen’s senior director of biosimilars, Sean McGowan, believes that momentum is continuing to build for US biosimilars in 2021, especially with key developments involving insulins and interchangeability on the horizon.
With several biologic molecules opened up to true multi-source competition over the course of 2020, the US biosimilars landscape now looks very different from the start of the year.