Latest From Biocon Ltd.
US FDA heard a predictably wide range of advice on the appropriate standards for approving biosimilar and interchangeable insulin during a public hearing on the topic. What is surprising is how few sponsors decided to speak out.
Approaches suggested at a US FDA public hearing include allowing follow-on insulins to take a direct route to interchangeability without first having to be approved as biosimilars, and automatically declaring biosimilar insulins interchangeable with one or more reference products.
As agency's hearing approaches, a Pink Sheet graphic charts the path for pending and approved applications for insulin, human growth hormone, and certain other protein products when the BPCIA ‘transition provisions’ take effect in March 2020.
Biocon rang in a strong fourth quarter amid signs of a build-up in efforts towards supporting the “independent functioning” of its biosimilars business under subsidiary Biocon Biologics.
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