Strides Begins Biosimilar Filings With Teriparatide
Expands COVID-19 Ambitions
Strides files for a biosimilar to Eli Lilly’s Forteo (teriparatide) in the EU, marking the beginning of its journey in the biosimilars segment. Meanwhile, it hopes to enter a manufacturing tie-up with COVID-19 vaccine players in H2 while also planning a launch of favipiravir in markets outside India.
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After a COVID-19-led manufacturing halt at its India facility and a slowdown in US launches hit Strides during the first quarter of FY22, the Indian firm is trying to fight back with an acquisition of assets from Endo and a growth strategy for Stelis Biopharma’s vaccines business, led by Sputnik V.
Strides will consider making RDIF’s Sputnik Light vaccine after filling orders for Sputnik V, which it expects to launch in October. The COVID-19 portfolio is being expanded and the Indian company is set to make a Para IV filing for a diabetes product in December, CEO R Ananthanarayanan tells Scrip.
As GDUFA III negotiations continue, FDA doesn’t seem ready to make additional changes to approval process, but industry argues guidance practices and communications need fixing and that consumers are missing out on potential savings because of it.