Biocon

Biocon's wholly owned subsidiary Biocon Biologics received marketing approval from Japan's Ministry of Health, Labour and Welfare for a pegfilgrastim biosimilar to Neulasta. Global Regulatory Partners Japan was named marketing authorisation holder, while Sandoz K.K. was to exclusively promote, sell and distribute the product in Japan. The approval added to Biocon's biosimilar portfolio, which accounted for 66% of operating revenue in the first quarter of FY27. Biocon reported FY26 revenue of ₹17,270 crore and launched five biosimilar products during that financial year.

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Aug 18 (Reuters) - Biocon Limited BION.NS:

• BIOCON- ANNOUNCES U.S. FDA APPROVAL FOR YESINTEK SINGLE-DOSE PREFILLED AUTOINJECTOR

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** Shares of Indian biopharmaceutical company Biocon BION.NS rise 2.3% to 434.80 rupees

** Co on Wednesday posted 4.5x net profit y/y; rev from sale of products up 16.5%

** Stock on avg rated "hold" by 16 analysts; median PT is 420 rupees - LSEG-compiled data

** Stock up 10.4% YTD

(Reporting by Abhirami G in Bengaluru)

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Aug 5 (Reuters) - Indian biopharmaceutical company Biocon BION.NS reported a more than fourfold jump in first-quarter net profit on Wednesday on strong revenue growth from its biosimilars segment.

• Consolidated net profit climbed to 1.41 billion rupees ($14.72 million) in the three months ended June 30.

• Revenue from its biopharma segment jumped 17% to 36.15 billion rupees. The segment, which includes biosimilars and generic drugs, accounts for 83% of Biocon's overall revenue.

• Biosimilars are lower-cost versions of complex biological drugs used to treat illnesses such as cancer, rheumatoid arthritis, psoriasis and diabetes.

• A favourable policy environment for biosimilars and expanded manufacturing capabilities in the U.S. will help long-term opportunities across North America, the company's biggest market, said executive chairperson and founder Kiran Mazumdar-Shaw.

• Biocon's services segment recorded a nearly 16% drop in revenue in the quarter.

• Revenue from the sale of products was up by 16.5% from last year, while revenue from the sale of services was down about 15%.

• Expenses grew 8.7%, largely due to an increase in cost of materials consumed.

• Shares of Biocon closed 0.8% higher ahead of the results.

($1 = 95.1175 Indian rupees)

(Reporting by Abhirami G in Bengaluru; Editing by Janane Venkatraman)

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Biocon Limited announced the commercial launch of Yesafili (aflibercept-jbvf), a US FDA-approved interchangeable biosimilar of Regeneron's Eylea 2 mg, in the United States. The product treats wet age-related macular degeneration and other serious eye conditions, and received FDA approval with interchangeable designation in May 2024. US sales of aflibercept reached roughly $5.89 billion in 2023. The launch extends Biocon's global biosimilar portfolio to 12 commercialized products, part of a broader FY26 acceleration that has included launches of Yesintek, Kirsty and other biosimilars.

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Biocon Limited announced the US commercial launch of Yesafili, its biosimilar to Regeneron's Eylea (aflibercept) 2 mg, on August 3. The product is now available in the United States as an FDA-approved interchangeable biosimilar, allowing substitution at the pharmacy level. US sales of aflibercept reached approximately $5.89 billion in 2023, giving the launch a substantial addressable market among the roughly 19.8 million Americans living with age-related macular degeneration. Yesafili was among the five biosimilar launches Biocon counted in fiscal 2026, and the company has now commercialized 12 biosimilar products globally.

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Aug 3 (Reuters) - Biocon Ltd BION.NS:

• BIOCON ANNOUNCES U.S. COMMERCIAL LAUNCH OF YESAFILI™, A BIOSIMILAR TO REGENERON’S EYLEA® 2 MG

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July 16 (Reuters) - Biocon Ltd BION.NS:

• BIOCON - BIOCON MALAYSIA RECEIVES EMA APPROVAL FOR NEW DRUG PRODUCT FILL FINISH UNIT FOR INSULINS

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Mylan Inc. disclosed on Tuesday that it sold its entire 5.64 percent stake in Biocon, selling 9.19 crore shares on the open market on July 14. The sale, worth approximately ₹4,000 crore at prevailing prices, completely exited the American pharmaceutical company from the Indian biopharmaceutical firm. Mylan and Biocon have shared a long-standing partnership in biosimilars, with Mylan previously holding the stake as a strategic investor. The disposal was disclosed under Regulation 29(2) of the SEBI Takeover Regulations. Mylan was not part of Biocon’s promoter group and had held the 5.64 percent stake without any encumbrances. Following the transaction, Mylan no longer holds any equity shares in the company. The exit may prompt investor questions about the future of the biosimilars alliance between the two firms.

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July 14 (Reuters) - Biocon Ltd BION.NS:

• MYLAN INC SELLS 46 MILLION BIOCON SHARES FOR 400 RUPEES/SHARE VIA BLOCK DEALS - BSE DATA

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Updates with company's response in bullet 4

By Yantoultra Ngui

SINGAPORE, July 13 (Reuters) - Mylan Inc, part of a global healthcare company Viatris VTRS.O, plans to sell up to 92 million shares in Indian drugmaker Biocon Ltd BION.NS, worth up to 34.81 billion Indian rupees ($363 million), according to a term sheet seen by Reuters.

• The sale represents up to 5.64% of Biocon's outstanding shares. It is a secondary sale, meaning the shares are being sold by an existing investor and Biocon will not receive the proceeds.

• The offer floor price is 378.50 rupees per share, a 7.9% discount to Biocon's last close of 410.95 rupees on Monday.

• Biocon did not immediately respond to an emailed request seeking comment.

• "We do not comment on market rumors or speculation," Viatris said in response to a Reuters request for comment.

• Citigroup Global Markets India and Jefferies India are joint bookrunners and brokers for the deal.

($1 = 95.6200 Indian rupees)

(Reporting by Yantoultra Ngui
Editing by Tomasz Janowski)

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May 11 (Reuters) - Biocon Ltd BION.NS:

• BIOCON - BIOCON PHARMA RECEIVES HEALTH CANADA APPROVAL FOR MICAFUNGIN FOR INJECTION, USP, 50 MG AND 100 MG

Source text: ID:nnAZN4SVCE2

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** Biocon BION.NS gains 2.68% to 392.50 rupees

** Drugmaker's Q4 consol net income rises ~2.6% y/y on growth led by biosimilars, generics businesses

** Revenue from generics up 13% y/y, biosimilars up 12%

** EBITDA rises 29% y/y

** Net profit before exceptional items rises 64% y/y; reported net profit drops ~63.5% y/y, hit by one-off exceptional charges

** Stock rated "buy" on average; median PT is 425 rupees, per data compiled by LSEG

** YTD, BION down ~1.36%, Nifty Pharma .NIPHARM up ~6%

(Reporting by Bipasha Dey in Bengaluru)

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Adds comments, details and background

By Rishika Sadam

May 5 (Reuters) - Kiran Mazumdar-Shaw, founder and chairperson of Biocon BION.NS, said on Tuesday that she plans a phased leadership transition over the next five years, with her niece Claire Mazumdar expected to eventually take over as chair.

Claire is the founding chief executive of Bicara Therapeutics BCAX.O, an oncology-focused biotech firm incubated with early backing from Mazumdar-Shaw and listed in 2024.

"I am not hanging up my boots anytime soon, but I want Claire to succeed me in a very phased manner," Mazumdar-Shaw told Reuters in a phone interview, adding that the transition would move step by step from director to vice-chair and eventually chair.

Mazumdar-Shaw founded Biocon in 1978 and is known to have started the company in a garage in the southern Indian city of Bengaluru.

Today, it is one of the world's leading biosimilars manufacturers, with a market capitalisation of 585.21 billion rupees ($6.14 billion), according to LSEG-compiled data.

Biocon derives a significant share of its revenue from the U.S. and European markets and has a portfolio of more than 30 biosimilars, 12 of which have been launched commercially, with more in development.

Biosimilars are lower-cost versions of complex biological drugs used to treat illnesses such as cancer, rheumatoid arthritis, psoriasis and diabetes. Biocon was among the earliest companies to develop biosimilar insulin.

"I want to make sure that the family legacy continues as long as we have this large stake (in Biocon)," Mazumdar-Shaw said, adding that her family members have been on the company's board. She holds a 29.92% stake in Biocon, per data from Refinitiv Workspace.

Prior to founding Bicara, 37-year-old Claire led business development and corporate strategy at Rheos Medicines and worked at Third Rock Ventures, focusing on company formation. She holds a PhD in cancer biology from Stanford School of Medicine.

"Claire's very aligned with my thinking (for company's future)," Mazumdar-Shaw said, adding that her niece will continue to play a role at Bicara during the transition.

The succession plan was first reported earlier in the day by Fortune India magazine.

(Reporting by Rishika Sadam, writing by Surbhi Misra; Editing by Nivedita Bhattacharjee and Sherry Jacob-Phillips)

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May 4 (Reuters) - Biocon Ltd BION.NS:

• BIOCON - BOARD TO CONSIDER INVESTMENT IN BIOCON BIOLOGICS VIA PREFERENTIAL EQUITY ALLOTMENT

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April 30 (Reuters) - Biocon Ltd BION.NS:

• BIOCON - U.S. FDA COMPLETES PRE-LICENSE INSPECTION AT BIOCON'S BIOSIMILARS SITE IN BENGALURU

• BIOCON - U.S. FDA ISSUES FORM 483 WITH FIVE OBSERVATIONS AFTER INSPECTION

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April 21 (Reuters) - Biocon Ltd BION.NS:

• RECEIVES HEALTH CANADA APPROVAL FOR BOSAYA AND VEVZUO BIOSIMILARS

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April 8 (Reuters) - Biocon Ltd BION.NS:

• BIOCON - UNIT RECEIVES U.S. FDA APPROVAL FOR DAPAGLIFLOZIN TABLETS, 5 MG AND 10 MG

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April 7 (Reuters) - Biocon Ltd BION.NS:

• BIOCON - ANNOUNCES U.S. COMMERCIAL LAUNCH OF BOSAYA AND AUKELSO, DENOSUMAB BIOSIMILARS

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March 27 (Reuters) - Biocon Ltd BION.NS:

• BIOCON - SIDDHARTH MITTAL TO STEP DOWN AS CEO AND MANAGING DIRECTOR EFFECTIVE MARCH 31, 2026

• BIOCON - APPOINTS SHREEHAS PRADEEP TAMBE AS CEO AND MANAGING DIRECTOR EFFECTIVE APRIL 1, 2026

• BIOCON - MUKESH KAMATH TO STEP DOWN AS INTERIM CHIEF FINANCIAL OFFICER

• BIOCON - APPOINTS KEDAR NARAYAN UPADHYE AS CHIEF FINANCIAL OFFICER EFFECTIVE APRIL 1, 2026

• BIOCON - APPOINTS KEDAR NARAYAN UPADHYE AS CHIEF FINANCIAL OFFICER

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Feb 24 (Reuters) - Biocon Ltd BION.NS:

• BIOCON OBTAINS APPROVAL FOR WEIGHT MANAGEMENT DRUG LIRAGLUTIDE IN THE UNITED STATES

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Repeats story from 13th Feburary with no changes to text

By Rishika Sadam

Feb 16 (Reuters) - Biocon BION.NS is aiming for high-double-digit percentage revenue growth as the Indian pharmaceutical firm prepares to launch generic versions of weight-loss drugs globally even as it remains cautious about an early rollout in the home market, a top company executive told Reuters.

The company is counting on demand for obesity medicines as it expands a pipeline that includes copycat versions of Novo Nordisk's NOVOb.CO Wegovy, whose patent for semaglutide in a few markets expires in 2026.

Indian drugmakers, including Dr Reddy's REDY.NS, Lupin LUPN.NS, Sun Pharmaceutical SUN.NS and at least half a dozen others are racing to bring cheaper copies to markets once the active compound goes off patent.

Bengaluru-based Biocon is targeting a U.S. launch of generic liraglutide in the first quarter of the next financial year, CEO Siddharth Mittal said in an interview on Friday. Liraglutide is also used for obesity treatment.

It aims to launch generic Wegovy in Canada next year, subject to regulatory approval, Mittal said. It is also planning launches over the next few years in India, Brazil, Mexico, Turkey, and parts of the Middle East and Latin America.

The company, however, is cautious about an early start in India due to fierce price competition and local clinical trial requirements, Mittal said.

"There's going to be fierce competition in India," Mittal said, citing low price expectations. He said Biocon is exploring approval in a specific overseas market first, which could help it seek a clinical trial waiver in India under local rules.

In India, Biocon would need to run a late-stage clinical trial before launch. The company is weighing whether that cost would be justified, Mittal said, or whether it should seek a waiver.

The obesity medicines market, according to several forecasts, is expected to reach at least $150 billion globally by the early 2030s, and analysts expect generic versions to be priced at least 60% below the originator products.

Biocon expects high double-digit percentage revenue growth, Mittal said. The company's annual revenue grew 5.4% in fiscal 2025 from a year ago, but it has been growing in early double-digits on a quarter-on-quarter basis.

India is not Biocon's main market. The company derives significant share of revenue from the United States and parts of Europe.

(Reporting by Rishika Sadam; Editing by Tasim Zahid)

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By Rishika Sadam

Feb 13 (Reuters) - Biocon BION.NS is aiming for high-double-digit percentage revenue growth as the Indian pharmaceutical firm prepares to launch generic versions of weight-loss drugs globally even as it remains cautious about an early rollout in the home market, a top company executive told Reuters.

The company is counting on demand for obesity medicines as it expands a pipeline that includes copycat versions of Novo Nordisk's NOVOb.CO Wegovy, whose patent for semaglutide in a few markets expires in 2026.

Indian drugmakers, including Dr Reddy's REDY.NS, Lupin LUPN.NS, Sun Pharmaceutical SUN.NS and at least half a dozen others are racing to bring cheaper copies to markets once the active compound goes off patent.

Bengaluru-based Biocon is targeting a U.S. launch of generic liraglutide in the first quarter of the next financial year, CEO Siddharth Mittal said in an interview on Friday. Liraglutide is also used for obesity treatment.

It aims to launch generic Wegovy in Canada next year, subject to regulatory approval, Mittal said. It is also planning launches over the next few years in India, Brazil, Mexico, Turkey, and parts of the Middle East and Latin America.

The company, however, is cautious about an early start in India due to fierce price competition and local clinical trial requirements, Mittal said.

"There's going to be fierce competition in India," Mittal said, citing low price expectations. He said Biocon is exploring approval in a specific overseas market first, which could help it seek a clinical trial waiver in India under local rules.

In India, Biocon would need to run a late-stage clinical trial before launch. The company is weighing whether that cost would be justified, Mittal said, or whether it should seek a waiver.

The obesity medicines market, according to several forecasts, is expected to reach at least $150 billion globally by the early 2030s, and analysts expect generic versions to be priced at least 60% below the originator products.

Biocon expects high double-digit percentage revenue growth, Mittal said. The company's annual revenue grew 5.4% in fiscal 2025 from a year ago, but it has been growing in early double-digits on a quarter-on-quarter basis.

India is not Biocon's main market. The company derives significant share of revenue from the United States and parts of Europe.

(Reporting by Rishika Sadam; Editing by Tasim Zahid)

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Feb 12 (Reuters) - Biocon Ltd BION.NS:

• Q3 CONSOL NET PROFIT 1.44 BILLION RUPEES

• Q3 CONSOL TOTAL INCOME 42.9 BILLION RUPEES

• ONE-TIME CHARGE OF 2.93 BILLION RUPEES IN Q3

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Feb 7 - Biocon Biologics Ltd BIOC.NS:

• BIOCON - FITCH RATINGS UPS UNIT BIOCON BIOLOGICS OUTLOOK TO POSITIVE FROM STABLE

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Jan 28 (Reuters) - Biocon Ltd BION.NS:

• RECEIVES VAI STATUS FROM US FDA FOR ANDHRA PRADESH FACILITY

• US FDA INSPECTION CONDUCTED BETWEEN NOVEMBER 3 AND 7, 2025

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Jan 21 (Reuters) - Biocon Ltd BION.NS:

• NOW HOLDS 98% OF BIOCON BIOLOGICS' EQUITY SHARE CAPITAL

Source text: ID:nBSE4qZGqt

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Jan 12 (Reuters) - Biocon Ltd BION.NS:

• BIOCON - FLOOR PRICE SET AT 387.74 RUPEES PER EQUITY SHARE

Source text: ID:nBSE1sbYTW

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