Tag: Biocon

Launch of Ogivri in the U.S. Announced

mylan
Biocon and its partner Mylan on December 2 announced the launch of Ogivri - a biosimilar to Herceptin - in USA. Ogivri was the first biosimilar of Herceptin to be approved by USFDA two years ago, f...

FDA Approved Biocon New Facility at Bengaluru

biocon
The US Food and Drug Administration (FDA) has approved Biocon Ltd's new facility at Bengaluru for the manufacturing of pegfilgrastim biosimilar Fulphila, the company said in a release. Approval for...

Biocon Received FDA Establishment Inspection Report for Biologics Drug Product Facility in Bengaluru...

biocon
Biocon Ltd, an innovation-led global biopharmaceuticals company, announced that it has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for its Biolog...

Evotec and Biocon Entered into Strategic Licensing Agreement for Biosimilar Asset

biocon
Evotec SE and Biocon Limited announced that Biocon Biologics, a wholly owned subsidiary of Biocon Ltd, and Just – Evotec Biologics, wholly owned by Evotec, have entered into a strategic licensing agre...

Biocon and Mylan Launched Semglee® in Australia

biocon
Biocon Ltd and Mylan N.V. announced the launch of Semglee® (insulin glargine solution for injection 100 IU/mL in a 3mL pre-filled pen), the first insulin glargine biosimilar in Australia available on ...

Biocon Signed Agreement with Subsidiary of CMS for Three Generic Formulation Products

biocon
Biocon Ltd, Asia’s premier biopharmaceuticals company, announced that it has signed a License and Supply Agreement with a subsidiary of China Medical System Holdings Ltd. (CMS) for three Generic Formu...

FDA Issued Response Letter for Biocon’s NDA for Insulin Glargine

biocon
U.S. FDA Issues Complete Response Letter for New Drug Application for Insulin Glargine; Commercialization Plans Remain Unchanged. “The U.S. FDA has issued a Complete Response Letter (CRL) for the N...

Biocon Received Certificate of GMP Compliance from EMA

biocon
Biocon Ltd, Asia’s premier biopharmaceuticals company, announced that it’s subsidiary in Malaysia, Biocon Sdn. Bhd., which operates Asia’s largest integrated Insulins facility, received the Certificat...