Biocon Announces Insulin Glargine Biosimilar Has Met Key Phase III Milestones, Is On Track for US and EU Regulatory Filings

Biocon recently announced that its global phase III clinical development program for biosimilar insulin glargine “has crossed key interim milestones,” putting Biocon “on track for regulatory filings in US and EU in FY 17.”

Biocon received regulatory approval in Japan for its biosimilar insulin glargine this past March after completion of local phase III clinical studies by Biocon’s commercial partner in Japan, FUJIFILM Pharma Co. Ltd.   Biocon announced that it expects to launch the product, which is branded in India as “Basalog One,” in Japan during the first quarter of fiscal year 2017.

Biocon also announced that it has “entered into a co-development agreement with its long-standing Mexican partner, Laboratorios PiSA, to target the opportunity for generic recombinant human insulin in the US market.”

Stay tuned for further developments here on the Big Molecule Watch.