Biocon Refutes Graft Charges After Regulatory Official Booked, Says Due Process Followed
Expert Panel Trial Waiver Endorsement Came In May
Indian investigating agency probes alleged bribe paid to drugs regulator in a case pertaining to the approval process of Biocon Biologics’ insulin aspart. The company strongly denies the allegations, underscoring that all its product approvals are backed by science and clinical data.
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A roundup of key regulatory and policy developments in the Asia-Pacific in the first half of the year reveals broad developments across the region's diverse markets, although there seemed to be a common thread - a renewed focus on infectious diseases amid the lingering impact of the pandemic and the emergence of new threats.
Biocon is progressing trials for biosimilar rivals to Amgen’s Prolia/Xgeva (denosumab) and J&J’s Stelara (ustekinumab), even as it gears for other large opportunities coming its way via the Viatris deal including for blockbusters Humira and Eylea.
Biocon seals milestone deal to acquire Viatris’s biosimilars assets for up to $3.3bn, accelerating its direct commercialization push across key markets and also bringing with it rights to key in-licensed therapies, including biosimilar adalimumab, and an option to acquire the US firm’s rights for biosimilar aflibercept.