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.

India’s Biocon has issued a response after a local English-language daily reported allegations that the company and one of its officials was involved in bribing the Joint Drugs Controller to waive Phase III clinical trial data for its proposed NovoLog (insulin aspart) biosimilar.

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.

Craig Burton, who replaces the FDLI-bound Christine Simmon, tells the Pink Sheet that fighting rebating practices which harm insulin patients now can pave the way for successful launches of Humira biosimilars next year. Biosimilar markets should not be ‘winner-take-all,’ he says.