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Latest From Biocon, Ltd.
First interchangeable insulin biosimilar gains preferred status on one of the largest national formularies in the US.
Six Form 483 observations of GMP deficiencies have been received from the US FDA by Biocon after the agency inspected the Malaysian manufacturing facility for its insulin aspart biosimilar. However, the Indian firm – which is partnered with Viatris on the product, for which an interchangeability designation is also being sought – insisted that US commercialization plans would not be affected.
As India gets set to resume COVID-19 vaccine diplomacy from October, a new rule which will require Indians visiting UK who are fully vaccinated with AstraZeneca partner Serum Institute’s vaccine to undergo quarantine has sparked a row. Meanwhile, Indian companies await a nod from the WHO for wider acceptance of their COVID-19 vaccines.
Biocon chairperson Kiran Mazumdar-Shaw says that venture capital firms have, with their risk-averse approach, "failed" the biotech sector in India. The executive draws attention to how "bold" venture funds that backed mRNA technology a decade ago were reaping gains today.
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