BIOCON

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

Further company coverage: BION.NS

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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

Source text: ID:nBSE3FXwyN

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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

Source text: ID:nNSE5Z9qN5

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

• RECEIVES HEALTH CANADA APPROVAL FOR BOSAYA AND VEVZUO BIOSIMILARS

Source text: ID:nBSE2TxjhJ

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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

Source text: ID:nBSE8pdZnk

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

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

Source text: ID:nBSE10Z4f4

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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

Source text: ID:nBSE5rJf10

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

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

Source text: [ID:]

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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

Source text: [ID:]

Further company coverage: BION.NS

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Feb 7 - Biocon Biologics Ltd BIOC.NS:

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

Source text: [ID:]

Further company coverage: BIOC.NS

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

Source text: ID:nNSEbKKsRs

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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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Jan 6 (Reuters) - Biocon Ltd BION.NS:

• BIOCON BIOLOGICS TO EXPAND BIOSIMILAR ONCOLOGY PORTFOLIO

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Jan 2 (Reuters) - Biocon Ltd BION.NS:

• ISSUES COMMERCIAL PAPERS WORTH 2 BILLION RUPEES

Source text: ID:nBSEbBWRB3

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** Biocon's BION.NS acquisition of minority stake in biosimilars unit Biocon Biologics BIOC.NS to make it wholly-owned subsidiary will remove holding company discount, add ~10% to Biocon's valuation, says JM Financial

** Retains "buy", with PT of 476 rupees; on avg, stock rated "buy", median PT is 435 rupees

** ICICI Securities says deal values Biocon Biologics at $5.5 bln, higher than earlier contemplated $4.5 billion

** Adds stake buy will lead to significant dilution - from 54% to 44% for promoters, from 46% to 37% for non-promoters

** Notes positive impact of holding co discount removal to nullify dilution concerns

** BION rises 7.47% this year, as of last close

(Reporting by Abhirami G in Bengaluru)

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** Shares of Biocon BION.NS fall 5.3% to 388 rupees, hitting their lowest in three weeks

** Pharma co to consider investment in Biocon Biologics via purchase of shares from existing shareholders for cash or through issuance of shares of co

** Systematix Institutional Equities analyst Vishal Manchanda says that to buyout minority interest in Biocon Biologics, BION may have to raise 100-150 billion rupees ($1.1 - $1.7 billion), which would mean meaningful dilution for shareholders of the company

** BION set for worst day since August 8

** Avg rating of 16 analysts covering the stock is "buy", their median PT is 433 rupees - data complied by LSEG

** Session's losses trim YTD gains to 6%

(Reporting by Nishit Navin in Bengaluru)

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By Rishika Sadam

Nov 13 (Reuters) - India's Biocon BION.NS expects a 50% drop in costs for developing complex biosimilars as the United States has proposed to ease clinical testing for the drugs that make up more than 60% of its revenue, a top executive said on Wednesday.

Biosimilars are copies of costlier biological drugs used to treat major illnesses such as cancer, rheumatoid arthritis, psoriasis and diabetes. The U.S. Food and Drug Administration last month proposed to simplify drug testing by lowering the requirement for large comparative clinical efficacy trials.

Biocon, which aims to cumulatively launch 20 biosimilars by 2030, is focusing on upcoming launches in the key markets of U.S. and Europe, Shreehas Tambe, CEO of Biocon Biologics, a unit of Biocon, said in an interview.

"You can do more because it's (FDA's draft proposal) going to halve the cost of development ... you can develop them (biosimilars) and bring them to patients faster and make it more affordable."

Biocon, which has seven of its biosimilars in the commercial market in the U.S., is looking to launch two more in the next six months. The company's oncology biosimilar medicines have a fourth of the U.S. market share and will benefit from the lower development cost, Tambe said.

The firm's revenue from biosimilars grew 25% in the latest quarter.

Biocon is also looking to expand its generics segment with the launch of weight-loss drugs to drive future growth, the company had said earlier.

(Reporting by Rishika Sadam; Editing by Harikrishnan Nair)

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

• BIOCON BIOLOGICS AND CIVICA EXPAND PARTNERSHIP AND LAUNCH PRIVATE-LABEL INSULIN GLARGINE TO BROADEN U.S. DIABETES TREATMENT OPTIONS

Source text: ID:nPn8Sc4Msa

Further company coverage: BION.NS

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** Biocon BION.NS falls 1.5% to 348 rupees; set to snap four-session gaining streak

** Biopharmaceutical co's U.S. manufacturing site in New Jersey's Cranbury gets one observation from U.S. FDA post inspection

** Cranbury site inaugurated last month

** Co says it will address observation within stipulated time; observation not expected to have any impact on business operations

** BION down ~5% YTD

(Reporting by Vijay Malkar)

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Rewrites, updates shares, adds analysts' comments

By Ananta Agarwal and Rishika Sadam

Sept 26 (Reuters) - Indian pharmaceutical stocks .NIPHARM fell 2% on Friday after U.S. President Donald Trump announced a 100% tariff on imports of branded and patented drugs, effective Oct. 1.

The U.S. is India's largest market for pharmaceutical exports, accounting for over a third of the total volume, mostly of cheaper generic drugs.

Of the 20 index constituents, 18 traded in the red as of 2:37 p.m. IST.

Analysts described the decline as "sentimental", noting that India's exports to the U.S. are primarily generic medicines, which may not be affected by the tariffs.

Sun Pharmaceutical Industries SUN.NS, India's largest drugmaker by revenue and the heaviest stock on the index, fell about 3%. Sun Pharma markets patented drugs, including Ilumya, a psoriasis treatment approved by the U.S. FDA.

The company also has a contract manufacturing unit through EU partners for specialty drugs, where a 15% tariff applies to EU exports to the U.S., according to Vishal Manchanda, equity analyst at Systematix Group.

"The impact on Sun is not very meaningful," he said. "It may be between 1% to 3% of EBITDA."

Laurus Labs LAUL.NS declined the most among constituents of the index, down about 6%.

"There is a general worry that CDMO (contract drug manufacturing organisations) might be impacted as the U.S. moves manufacturing in-house," Manchanda added.

Biocon, which makes complex biosimilars for cancer treatment and has significant U.S. exposure, is down about 4.6%.

"Uncertainty remains whether complex generics and biosimilars will face future tariffs," ICICI Securities analyst Pankaj Pandey said in a note on Friday.

(Reporting by Ananta Agarwal in Bengaluru; Editing by Nivedita Bhattacharjee and Janane Venkatraman)

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** Shares of Biocon BION.NS rise 2.2% to 362.05 rupees

** Pharmaceuticals co's subsidiary Biocon Biologics gets U.S. Food and Drug Administration approval for Bosaya and Aukelso

** Drugs are biosimilars of Denosumab, made by U.S. pharma firm Amgen AMGN.O

** Bosaya approved for treatment of postmenopausal women with osteoporosis

** Aukelso approved for prevention of skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors

** U.S. FDA also granted provisional interchangeability designation for both drugs

** BION down ~1% YTD

(Reporting by Vijay Malkar)

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Sept 17 (Reuters) - Biocon Ltd BION.NS:

• BIOCON BIOLOGICS RECEIVES U.S. FOOD AND DRUG ADMINISTRATION APPROVAL FOR BOSAYA™ AND AUKELSO™, DENOSUMAB BIOSIMILARS

• BIOCON LTD - FDA GRANTS INTERCHANGEABILITY FOR BOSAYA AND AUKELSO

Source text: ID:nPn7Kkx5ba

Further company coverage: BION.NS

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** Shares of drugmaker Biocon Limited BION.NS rise 2.2% to 364.8 rupees, their biggest intraday pct gain in more than three weeks

** The U.S. FDA completes inspection at Biocon Biologics' Bengaluru facility with five procedural observations

** Co says unit will address all observations; no impact on product supply expected

** Stock rated "buy" on avg; median PT is 400 rupees - data compiled by LSEG

** Stock has lost 0.75%, YTD

(Reporting by Aleef Jahan in Bengaluru)

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

• BIOCON LTD - USFDA COMPLETES INSPECTION AT BIOCON BIOLOGICS FACILITY IN INDIA

• BIOCON LTD - FDA ISSUES FORM 483 WITH FIVE OBSERVATIONS

Source text: ID:nNSE8bySzN

Further company coverage: BION.NS

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