Intas has announced that its Accord Healthcare unit has filed in Europe the DMB-3115 biosimilar ustekinumab candidate licensed from Japan’s Meiji Seika Pharma and Korea’s Dong-A.
As the race continues to heat up for biosimilar rivals to Stelara (ustekinumab), Intas Pharmaceuticals has become the latest company to confirm a filing after announcing that its Accord Healthcare subsidiary has filed its version – licensed from Japan’s Meiji Seika Pharma and Korea’s Dong-A – with the European Medicines Agency.
Indicating that the EMA had confirmed its acceptance of the DMB-3115 candidate on 14 July, Intas said this came after...
The US healthcare system saved billions by allowing early market entry for generic and biosimilar medicines through patent settlements. However, long-winded litigations with an expensive price tag and the Senate’s reintroduced pay-for-delay bill are set to make the situation even more dire.
After multiple past attempts, US legislators have once again proposed a bill that would make all biosimilars immediately interchangeable upon approval. Could a fresh political context help it to succeed this time?
After a series of setbacks for its Lucentis (ranibizumab) biosimilar filing in the US, Xbrane Biopharma now has a fresh action date from the FDA – although any approval will be contingent on a successful agency reinspection of its manufacturing sites.
After previously partnering on denosumab, Alvotech and Dr Reddy’s have announced a further alliance to co-develop a biosimilar version of Keytruda (pembrolizumab).
After a series of setbacks for its Lucentis (ranibizumab) biosimilar filing in the US, Xbrane Biopharma now has a fresh action date from the FDA – although any approval will be contingent on a successful agency reinspection of its manufacturing sites.
After previously partnering on denosumab, Alvotech and Dr Reddy’s have announced a further alliance to co-develop a biosimilar version of Keytruda (pembrolizumab).
Marking its first vertically integrated GLP-1 product in India, Biocon said the generic liraglutide was approved under CDSCO’s Rule 101, which recognizes approvals from “established and referenced serious regulatory authorities.”
