Drug Approval | April 28, 2025
Biocon Biologics receives positive CHMP opinions for biosimilar Denosumab in Europe
The positive opinions are based on applications submitted by Biosimilar Collaborations Ireland Limited
The positive opinions are based on applications submitted by Biosimilar Collaborations Ireland Limited
Recommendation based on results of Phase 3 CheckMate -9DW clinical trial demonstrating statistically significant and clinically meaningful improvement in overall survival with Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib in this patient population
Final decision from the European Commission is anticipated within the coming months
Opinion granted based on positive overall survival results from the IND.227/KEYNOTE-483 trial
Doses will be ready to ship to applicable European Union (EU) member states as soon as possible upon European Commission (EC) authorization
New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids
Positive opinion granted for KEYTRUDA plus chemotherapy for the first-line treatment of adult patients with primary advanced or recurrent endometrial carcinoma
Decision on EU marketing authorisation for this population expected by September 2024
Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance
Imfinzi also recommended for patients with mismatch repair deficient disease
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