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Mylan, Biocon to launch Adalimumab Biosimilar in EU biospectrumasia
April 16, 2018
FKB’s product is at an advanced stage of review and could potentially obtain approval in Europe in the second half of 2018.
Biocon gets European nod for its insulin to market globally biospectrumasia
March 29, 2018
Biocon and Mylan received approval from the European Commission and the Australian regulatory body for marketing biosimilar insulin glargine globally
Mylan-Biocon’s breast cancer biosimilar gets ANVISA nod expressbpd
January 02, 2018
Biocon and Mylan’s proposed biosimilar trastuzumab has been approved by Brazilian regulatory agency ANVISA, through their partner Libbs Farmaceutica (Libbs).
Biocon receives EIR from US FDA expressbpd
November 22, 2017
Biotechnology firm Biocon has received the Establishment Inspection Report (EIR) with ’voluntary action indicated’ status from the US FDA on closure of inspection of its aseptic drug product facility.
Biocon bags recognition at Science Careers Top Employers Survey expressbpd
October 25, 2017
The survey was based on an evaluation of 23 characteristics including financial strength, easy adaptation to change, and a research-driven environment
Biocon receives CRL from US FDA over cancer treatment biosimilar expressbpd
October 12, 2017
Biotechnology firm Biocon said the US health regulator has issued complete response letter (CRL) for Mylan’s application for proposed biosimilar Pegfilgrastim, indicated for use in treatment of cancer.
Biocon collaborates with JDRF expressbpd
September 07, 2017
JDRF provides financial support to accelerate breakthrough research in Type 1 Diabetes management
Biocon pulls EU Herceptin biosim app but expects to return to the race next quarter fiercepharma
August 17, 2017
Biocon says it expects to finish plant fixes required by the European Medicines Agency by the end of August and will resubmit its application for a Herceptin biosimilar after that.
Biocon withdraws application for EU approval of two drugs expressbpd
August 17, 2017
EU drugs regulator sought re-inspection of their production facility
FDA unanimously recommends Mylan and Biocon's Herceptin biosimilar pharmafile
July 17, 2017
Mylan and Biocon have revealed that their biosimilar version of Roche and Genentech’s Herceptin (trastuzumab) has received unanimous recommendation from the FDA’s Oncology Drugs Advisory Committee (ODAC) for the treatment of breast cancer.

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