The US FDA issues Biocon a Form 483 with two observations, including failure to establish proper aseptic practices and lack of follow-up on data discrepancies.
As an increasing number of biosimilar developers target the European market, lesser-known firms may explore alternative commercialisation strategies, says Iqvia executive.
Drug firms that want to trial or sell vaccines in India, or import them into the country, will need to seek CDSCO permission via an online portal from now on.
