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).
Posted by Dr. Tim Sandle
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