Indian biosimilars guidelines go on stream amid implementation concerns

India is set to implement its first set of guidelines on biosimilars next month, lending much-needed clarity to the approval pathway for such products, though concerns persist on whether the country's regulatory machinery is geared to implement these effectively.

The guidelines, which outline the data requirements for the production, characterisation, preclinical and clinical trials for the marketing approval of similar biologics in India, are set to become applicable on...