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Biocon And Mylan's Fulphila And Insulin Plans On Track

FDA Expected To Inspect Malaysia Insulins Facility In February

 
• By Anju Ghangurde

Biocon and Mylan press ahead with plans to broaden patient access in the US to biosimilar pegfilgrastim and are enthused with the initial uptake for their trastuzumab biosimilar ahead of more upcoming competition. A mid-2020 US launch for partnered insulin glargine is also on course.

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Momentum For Biocon-Mylan Biosimilars Portfolio • Source: Shutterstock

Biocon appears strikingly upbeat about prospects in the US for its biosimilar follow-on to Sanofi’s Lantus (insulin glargine), sticking to a mid-2020 launch timeline for the product, which is partnered with Mylan.

Biocon had been racing to set right compliance issues at its Malaysian site for the product amid previous concerns that its application could get stuck in the transition of insulins from drug to biologic regulation in the US

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