Tuesday, 28 June 2016

India Releases New Biosimilars Guidance


India’s Central Drugs Standard Control Organization on Saturday released new guidance for biosimilar developers as new biosimilars come to market there before other regions, and as India's regulators look to develop more specific guidance on postmarketing studies.

The new document is a slight tweak of previous guidance issued in 2012, but includes several important changes that are now up for discussion through 30 April. India's biosimilars market currently includes eight biosimilars, including one for AbbVie's blockbuster Humira (adalimumab) and two biosimilars for Roche's breast cancer treatment Herceptin (trastuzumab), which are not approved in any other countries (though Korea's Food and Drug Administration has approved a different Herceptin biosimilar), according to the industry blog Biosimilarz (the Generics and Biosimilars Initiative lists more than 60 approved biosimilars in India).

For further details see: similars

Posted by Dr. Tim Sandle