Biocon Ltd. — Regulatory Filings 2021

Mar 1, 2021

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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

March 1, 2021

To, The Manager BSE Limited Department of Corporate Services Phiroze Jeejeebhoy Towers, Dalal Street,Mumbai – 400 001	To, The Manager National Stock Exchange of India Limited Corporate Communication Department Exchange Plaza, Bandra Kurla Complex Mumbai – 400 050
Scrip Code – 532523	Scrip Symbol - Biocon

Subject: Press Release titled “Biocon Biologics and Viatris Inc. Receive CHMP Nod for Abevmy®, a Biosimilar to Avastin® (Bevacizumab)”.

Dear Sir/Madam,

Please find enclosed the press release titled “Biocon Biologics and Viatris Inc. Receive CHMP Nod for Abevmy®, a Biosimilar to Avastin® (Bevacizumab)”.

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,

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For Biocon Limited

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___ Mayank Verma Company Secretary and Compliance Officer

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PRESS RELEASE

Biocon Biologics and Viatris Inc. Receive CHMP Nod for Abevmy[®] , a Biosimilar to Avastin[®] (Bevacizumab)

BENGALURU, India– March 1, 2021 –

Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing authorization of their biosimilar Bevacizumab, co-developed with Viatris, to be marketed as Abevmy[®] (injection bevacizumab 100mg and 400mg). Abevmy[®] is a biosimilar to Roche’s Avastin[®] , prescribed for all indications including metastatic colorectal carcinoma, metastatic breast cancer, non-small-cell lung carcinoma, glioblastoma, ovarian, cervical and renal cancer as part of a specific regimen.

The decision of the European Commission (EC) is expected in May 2021, which, when approved, will grant marketing authorization in the 27 European Union (EU) member countries and European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein. For the U.K., the Medicines and Healthcare Products Regulatory Agency’s “reliance procedure” will be followed, and the U.K. marketing authorization can be expected shortly after the EC decision.

Kiran Mazumdar-Shaw, Executive Chairperson, Biocon Biologics , said: “CHMP's decision to recommend approval of our biosimilar Bevacizumab brings us a step closer to enable affordable access to this biologic therapy for cancer patients in the EU along with our partner Viatris. It is an outcome of our commitment to expand access for patients leveraging our science and global scale manufacturing for a range of biosimilars. Through bTrastuzumab and bPegfilgrastim we are already making a difference to the lives of cancer patients in several EU countries. We look forward to a final decision from the European Commission approving biosimilar Bevacizumab, which will add to our efforts in cancer care.”

Abevmy, bBevacizumab, is a recombinant “humanized” monoclonal antibody that selectively binds to human vascular endothelial growth factor (VEGF) and neutralizes its biologic activity. Bevacizumab inhibits the formation of tumor vasculature, thereby inhibiting tumor growth.

About Biocon Biologics Limited

Biocon Biologics Limited, a subsidiary of Biocon Limited is uniquely positioned as a fully integrated ‘pure play’ biosimilars organization in the world. Building on the four pillars of Patients, People,

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Partners and Business, Biocon Biologics is committed to transforming healthcare and transforming lives. Biocon Biologics is leveraging cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. It has a platform of 28 biosimilar molecules across diabetes, oncology, immunology, dermatology, ophthalmology, neurology, rheumatology and inflammatory diseases. Five molecules from Biocon Biologics’ portfolio have been taken from lab to market, of which three have been commercialized in developed markets like United States, EU, Australia, Canada and Japan. With a team of over 4800 people Biocon Biologics aspires to transform healthcare through affordable innovative solutions as well as impact 5 million patients’ lives by FY 22. BioconBiologics on the Web Follow-us on Twitter: @BioconBiologics

About Biocon Limited

Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US and Europe. It also has a pipeline of promising novel assets in immunotherapy under development. Website: www.biocon.com; Follow-us on Twitter: @bioconlimited

Forward-Looking Statements: Biocon

This press release may include statements of future expectations and other forward-looking statements based on management's current expectations and beliefs concerning future developments and their potential effects upon Biocon Limited, Biocon Biologics Limited and its subsidiaries/ associates. These forward-looking statements involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from our expectations include, amongst other: general economic and business conditions in India and overseas, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currency changes, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition in and the conditions of the Indian and global biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. Neither Biocon Limited, nor Biocon Biologics Limited, nor its Directors, nor any of its subsidiaries/associates assume any obligation to update any particular forwardlooking statement contained in this release

Contacts:

Contacts:
BIOCON BIOLOGICS
MEDIA Seema Ahuja Sr. VP & Global Head of Communications & Corporate Brand Biocon Group & Biocon Biologics +91 80 2808 2222 +91 99723 17792 seema.ahuja@biocon.com	INVESTORS Nikunj Mall Head, Investor Relations Biocon Biologics 91 998 777 4078 nikunj.mall@biocon.com