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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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.
Indian firms are getting their act together in areas like cell and gene therapy, with Dr Reddy’s aiming big and readying a facility alongside an alliance with a Chinese firm for a CAR-T therapy. The company is also doubling down in contract development and manufacturing, with an eye on opportunities in biologics.