COVID-19 Dents Biocon Ahead Of Insulin Opportunity
Pandemic-Related R&D Underway, UAE JV Wound Up
Biocon’s fourth-quarter earnings were impacted by pandemic-related disruptions, especially its biologics arm, but the Indian firm anticipates a “good recovery.” All eyes will be on the anticipated US launch of biosimilar insulin glargine and its interchangeability status, while the company remains confident of delivering a $1bn FY2022 revenue target for biologics.
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Tentative FDA approval for Lupin’s arformoterol tartrate inhalation solution and a potential EC nod for etanercept are seen aiding the company’s prospects in FY2021. Besides, success in a Phase III trial for secnidazole to treat trichomoniasis bodes well, though manufacturing clearances and continuity will also be closely watched.
A US district court has ruled in favor of Mylan in a dispute with Sanofi over a Lantus SoloStar device patent, with the patent protecting the insulin glargine injector pen found to be invalid and not infringed. Mylan, along with partner Biocon, expects to launch its Semglee version mid-year, following FDA approval.
Biocon-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.