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Biocon Ltd. Regulatory Filings 2021
61176_rns_2021-02-12_c2727f33-8499-4eba-85e2-aae7fa9af605.pdf
Regulatory Filings
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Biocon Limited 20th KM, Hosur Road Electronic City Bangalore 560 100, India T 91 80 2808 2808 F 91 80 2852 3423
CIN : L24234KA1978PLC003417
www.biocon.com
February 12, 2021
| To | To |
|---|---|
| The Manager | The Manager, |
| BSE Limited | National Stock Exchange of India Limited |
| Department of Corporate Services | Corporate Communication Department |
| Phiroze Jeejeebhoy Towers, | Exchange Plaza, Bandra Kurla Complex |
| Dalal Street, Mumbai – 400 001 | Mumbai – 400 050 |
| Scrip Code - 532523 | Scrip Symbol - Biocon |
Subject: Company Statement
Dear Sir/Madam,
Please find enclosed the Company Statement titled "Biocon Biologics and Viatris Receive European Commission Approval for Kixelle, Biosimilar Insulin Aspart".
The above information will also be available on the website of the Company at www.biocon.com.
Kindly take the same on record and acknowledge.
Thanking You,
Yours faithfully,
For Biocon Limited
_______________
Mayank Verma Company Secretary and Compliance Officer
NOTIFICATION TO STOCK EXCHANGE
COMPANY STATEMENT
Biocon Biologics and Viatris Receive European Commission Approval for Kixelle, Biosimilar Insulin Aspart
Bengaluru, India; February 12, 2021:
"This is to inform that Biocon Biologics Ltd., a subsidiary of Biocon Ltd. (BSE code: 532523, NSE: BIOCON), has announced that Kixelle, a biosimilar Insulin Aspart co-developed with Viatris Inc. (NASDAQ: VTRS), has received marketing authorization approval from the European Commission following the positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. Kixelle, a fast-acting insulin analog indicated for the treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above, has been approved as a 100 units/ml solution for injection in vial and pre-filled pen presentations.
The centralized marketing authorization granted by the EC is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.
"The European Commission's approval of our biosimilar Insulin Aspart is an endorsement of the quality of our product and the data generated during its development. The approval will enable affordable access to a rapid acting insulin analog for people with diabetes in the EU, where our biosimilar Insulin Glargine, a long acting insulin analog, is already addressing patients' needs for an affordable quality treatment option. We are leveraging our science, expertise and global scale manufacturing to expand access to our high quality, affordable biologics, globally."
-- Company Spokesperson, Biocon Biologics.
For more information [email protected] +919972317792