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Biocon Ltd. — Regulatory Filings 2020
Dec 14, 2020
61176_rns_2020-12-14_06345d43-8e93-416a-93ab-8cc00d11e0ef.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
December 14, 2020
| ToThe ManagerBSE LimitedDepartment of Corporate ServicesPhiroze Jeejeebhoy Towers,Dalal Street,Mumbai – 400 001 | ToThe Manager,National Stock Exchange of India LimitedCorporate Communication DepartmentExchange Plaza, Bandra Kurla ComplexMumbai – 400 050 |
|---|---|
| Scrip Code- 532523 | Scrip Symbol- Biocon |
Dear Sir/Madam,
Subject: Biocon Biologics and Mylan Receive CHMP Recommendation for Approval of Biosimilar Insulin Aspart
Please find below the “Company Statement” on the subject matter.
This is to inform you that Biocon Biologics Ltd., (a subsidiary of Biocon Ltd.), and Mylan (a subsidiary of Viatris Inc.) have received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommending approval of the market authorization of Kixelle, a biosimilar Insulin Aspart, which is a rapid acting insulin for the treatment of Type 1 and 2 diabetes.
The CHMP positive opinion will be considered by the European Commission. The European Commission decision on the approval is expected early next year.
Dr. Christiane Hamacher, CEO, Biocon Biologics, said: “We are extremely pleased to receive a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for our biosimilar Insulin Aspart co-developed with Mylan. This is an endorsement of the quality of our product and the data generated during its development. We look forward to a final decision from the European Commission approving Insulin Aspart, which will enable us to expand our offering to people with diabetes to include a rapid acting insulin analog along with a long acting insulin glargine.”
Kindly take the same on record and acknowledge.
Thanking You,
Yours faithfully,
For Biocon Limited
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Mayank Verma Company Secretary and Compliance Officer