Biosimilars: US FDA Developing Guidance For First Interchangeable Exclusivity
First Interchangeable Biosimilar Approved Is Entitled To One Year Of Exclusivity
The first biosimilar with interchangeability status compared to its reference will be entitled to one year of exclusivity, a largely overlooked advantage in the early days of the US biosimilar market.
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A draft guidance document opened for comment by the FDA offers additional Q&As on issues around biosimilar applications and interchangeability.
Mylan and Biocon have launched their Semglee version of insulin glargine in the US, revealing pricing details for the Lantus rival. At the same time, the firms have offered an update on their attempts to have Semglee classified as a biosimilar as they seek an interchangeability designation.
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.