The Factory Floor: Biocon Celebrates Malaysian Insulin Plant Clearance
As MedPharm And Lupin Successfully Complete FDA Inspections
Biocon has reported FDA clearance for its Malaysian insulin facility, while Lupin and Xellia have also received plant approvals. Meanwhile, Alembic has seen mixed fortunes, receiving both Form 483 observations and an EIR.
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Biocon is actively expanding its biosimilars manufacturing capacity with an aim to further penetrate EU markets after receiving a GMP approval for a key manufacturing site. The company has ramped up production for trastuzumab and pegfilgrastim, while awaiting approval for bevacizumab.
Tentative FDA approval for Lupin’s arformoterol tartrate inhalation solution and a potential European 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.