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.

Serum to hold 15% in Biocon arm Biocon Biologics as part of a broad alliance that expects to leverage the partners' strengths and resources in vaccines and biologics. Pursuing opportunities based on the hot mRNA technology platform appears firmly on the table.