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Biocon Confident As First Biosimilars Seen Hitting Europe In Early 2018

Executive Summary

India’s leading biologics company Biocon has said it expects its first biosimilar products to be launched in the European market by early 2018 and is bullish on both its plans in the sector and earnings prospects after reporting quarterly net profit soared by a better than expected 52%.

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Will GMP Lapses Stall Biocon-Mylan’s Biosimilars Build-Up?

Compliance deviations flagged by French regulator ANSM at Biocon’s Indian site have raised questions around commercialization timelines in the EU for the firm and partner Mylan’s biosimilars, including trastuzumab. The news comes ahead of an FDA advisory panel review later this week for the product. Biocon, though, appears confident of setting compliance woes right quickly.

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