BIOCON

** 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 - UNIT RECEIVES USFDA APPROVAL FOR BOSAYA, AUKELSO, DENOSUMAB BIOSIMILARS

• BIOCON - U.S. FDA GRANTED PROVISIONAL INTERCHANGEABILITY DESIGNATION FOR BOSAYA, AUKELSO

Source text: ID:nnAZN4JBIN3

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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July 23 (Reuters) - Biocon Ltd BION.NS:

• BIOCON - BIOCON BIOLOGICS LAUNCHES NEPEXTO

• BIOCON - UNIT LAUNCHES NEPEXTO IN AUSTRALIA

Source text: ID:nBSEc1tNjS

Further company coverage: BION.NS

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** Shares of Biocon BION.NS rise 2.3% to 396.3 rupees, highest since February

** Unit gets U.S. FDA approval for rapid-acting insulin analog Kirsty, used to treat diabetes

** More than 11.9 mln shares traded, twice the 30-day avg

** Analysts' avg rating on stock is "buy"; median price tag is 295 rupees - data compiled by LSEG

** Stock up 8.5% YTD

(Reporting by Aleef Jahan in Bengaluru)

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July 15 (Reuters) - FDA:

• US FDA APPROVES BIOCON BIOLOGICS BLA FOR KIRSTY

• FDA: KIRSTY (INSULIN ASPART-XJHZ) IS BIOSIMILAR TO NOVOLOG (INSULIN ASPART)

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

• BIOCON BIOLOGICS RECEIVES MHRA UK APPROVAL FOR DENOSUMAB BIOSIMILARS

• BIOCON BIOLOGICS RECEIVES MHRA UK APPROVAL FOR VEVZUO AND EVFRAXY

Source text: ID:nBSE6hQQLL

Further company coverage: BION.NS

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

• BIOCON - EUROPEAN COMMISSION APPROVES BIOCON BIOLOGICS’ DENOSUMAB BIOSIMILARS

• BIOCON - EUROPEAN COMMISSION GRANTED MARKETING AUTHORISATION IN EU FOR VEVZUO, EVFRAXY

Source text: ID:nnAZN435IQR

Further company coverage: BION.NS

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

• BIOCON - BIOCON BIOLOGICS EXPANDS INSULIN ACCESS IN MALAYSIA

Source text: ID:nNSE3PN7yT

Further company coverage: BION.NS

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SHANGHAI, June 27 (Reuters) - Indian drugmaker Biocon BION.NS has abandoned plans to market generic versions of Novo Nordisk’s NOVOb.CO hot-selling diabetes and weight-loss drugs in China due to local competition, a senior executive said.

"We decided not to do it in China, not supply or register the product in China, either finished product or the API, because there is ample capacity and players available in China," Amit Kaptain, head of Biocon's commercial active pharmaceutical ingredients (API) business, told Reuters in Shanghai.

Kaptain had said in 2024 that Biocon was aiming to launch its versions of Novo's diabetes and weight-loss drugs Ozempic and Wegovy in the world’s second-biggest economy after clinical trials.

Biocon's diabetes and weight-loss products would have joined at least 15 other generics or biosimilars in development by Chinese drugmakers, Reuters has reported. Biosimilars are versions of a drug that are highly similar to approved medications.

Chinese drugmakers have rushed to develop generics or biosimilars as the patent for semaglutide, a key ingredient in both Ozempic and Wegovy, ends in early 2026 in China.

The number of adults in China who are overweight is projected to reach 540 million in 2030 and those who are obese 150 million, increases of 2.8 and 7.5 times respectively from the year 2000, according to a 2020 study by Chinese public health researchers.

(Reporting by Andrew Silver; Editing by Miyoung Kim and Tom Hogue)

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June 20 (Reuters) - Biocon Ltd BION.NS:

• RAISES 45 BILLION RUPEES THROUGH QIP

Source text: ID:nBSE1N5x1G

Further company coverage: BION.NS

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** Shares of drug maker Biocon BION.NS rise 2.5% to 350.5 rupees apiece

** HSBC reiterates "buy" on BION, saying that a successful QIP (qualified institutional placement, a fundraising tool) should ease debt burden

** On Monday, BION launched a QIP to raise 45 billion rupees to pay off financial obligations

** Easing debt burden to help BION sharpen its focus on biosimilars scale-up, says HSBC

** Remains positive about the turnaround of BION's biosimilars segment and says the execution of upcoming launches crucial for BION

** Trims target price to 390 rupees from 400 rupees to account for the rising shareholder base after the QIP

** HSBC's new target price implies a 10.6% upside for BION

** The average rating of 15 analysts tracking BION is buy; median target price is 395 rupees, data compiled by LSEG shows

** BION shares are down 6.4% in 2025 so far, mirroring the 8.3% fall in pharma index .NIPHARM, exchange data shows

(Reporting by Bharath Rajeswaran in Bengaluru)

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

• BIOCON BIOLOGICS AND YOSHINDO EXPAND ACCESS TO USTEKINUMAB BIOSIMILAR IN JAPAN

Source text: [ID:]

Further company coverage: BION.NS

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

• IN FY26, WE EXPECT TO SEE A RECOVERY IN API BUSINESS

• FOCUSED ON STRATEGIC EXPANSION OF DIFFERENTIATED GLP-1 PORTFOLIO INTO NEW MARKETS

Source text: ID:nBSE9XfQ98

Further company coverage: BION.NS

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** Biocon BION.NS climbs 4.4% to 332.80 rupees

** Drugmaker's unit Biocon Biologics gets marketing access for its immunotherapy drug Yesintek - Biocon's biosimilar for Janssen Biotech's Stelara - in the U.S.

** The therapy, chemically called ustekinumab, is used for treating patients with chronic plaque psoriasis

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

** Session's gains trim BION's YTD losses to 8.9%

(Reporting by Kashish Tandon in Bengaluru)

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April 23 (Reuters) - Biocon Ltd BION.NS:

• BIOCON LTD - TO RAISE UP TO 45 BILLION RUPEES VIA SECURITIES ISSUANCE

• BIOCON - RAISING OF FUNDS BY WAY OF QUALIFIED INSTITUTIONS PLACEMENT OR ANY OTHER METHOD

Source text: ID:nBSEcbGDKm

Further company coverage: BION.NS

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April 15 (Reuters) - Biocon Ltd BION.NS:

• BIOCON LTD - BIOCON BIOLOGICS SECURES U.S. MARKET ENTRY FOR YESAFILI BIOSIMILAR

• BIOCON LTD - YESAFILI TO LAUNCH IN U.S. IN SECOND HALF OF 2026 OR EARLIER

• BIOCON - BIOCON BIOLOGICS, REGENERON EXECUTED SETTLEMENT AGREEMENT TO DISMISS PENDING APPEAL

Source text: ID:nBSEz8sQy

Further company coverage: BION.NS

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** Shares of biopharma firm Biocon BION.NS climb 3.5% to 320 rupees

** The U.S. FDA approvesco's biosimilar drug, Jobevne, which combats cancer by restricting blood supply to the tumor

** Separately, the U.S. FDA also approvesunit's drug Everolimus, used to treat organ rejection in kidney and liver transplantation

** Biocon is the third-biggest gainer in the Nifty pharma index .NIPHARM, which is up 2.5%, tracking broader markets after the U.S. paused steep reciprocal tariffs

** Stock down 13% so far in 2025 vs a 12.5% drop in the pharma index

(Reporting by Nishit Navin)

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April 10 (Reuters) - Biocon Ltd BION.NS:

• BIOCON LTD - U.S. FDA APPROVES BIOCON BIOLOGICS'S BEVACIZUMAB BIOSIMILAR, JOBEVNE

Source text: ID:nNSE5l9jrj

Further company coverage: BION.NS

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Adds analyst comments in paragraphs 11-12, updates share moves throughout

By Manas Mishra and Ananta Agarwal

April 9 (Reuters) - Global drugmakers' stocks dropped across the board after U.S. President Donald Trump reiterated plans for a "major" tariff on pharmaceutical imports, threatening an interwoven global supply chain, and as his country-specific reciprocal tariffs took effect, leading to more pain in global markets.

Pharmaceutical imports were initially exempt from Trump's first set of reciprocal tariffs last week — but his administration has since indicated that levies on the sector, which in the past has been excluded from such actions, are coming.

The U.S. president has said the tariffs will incentivize drug companies to move operations to the United States. However, analysts and companies have raised concerns about the difficulty in setting up manufacturing in the country.

Shares of major U.S. drugmakers Amgen AMGN.O, AbbVie ABBV.N, Pfizer PFE.N, Merck MRK.N and Eli Lilly LLY.N fell between 3% and 6% in premarket trading.

In Europe, a basket of healthcare stocks .SXDP fell 5% to its lowest since October 2022, leading losses among sectoral indexes on the region-wide STOXX 600 .STOXX, which was down 3.3% at 1013 GMT. The index was heading for its biggest one-day drop since March 2020.

Trump had also threatened the duties on Friday after his first set of "reciprocal" tariffs exempted pharma products. Trump has not said when and by how much he plans to raise levies on pharma imports.

"While the details are scant, we are strongly opposed to tariffs on any pharmaceuticals — these will likely do little to shift manufacturing back to the U.S.," said BMO Capital Markets analyst Evan Seigerman.

"Given the complexity of the pharma supply chain, we do not expect the industry to make any major changes. These current tariffs are being pursued under emergency powers, which at worse will last until the end of the current administration and could end sooner with an act of Congress."

Seigerman also pointed to concerns over recent layoffs at the U.S. Food and Drug Administration, saying the worries were now compounded by the "real talk" of pharma tariffs.

ADDITIONAL COSTS, LONG WAIT FOR PRODUCTION

Europe and the U.S. have interconnected supply chains for medicines. The United States depends on medicines partly produced in Europe that bring in hundreds of billions of dollars in revenue.

Bernstein analyst Courtney Breen wrote in a note that her worst-case scenario assumes tariffs could be steep, leading to about $53 billion in additional costs paid for pharmaceutical imports.

If companies did choose to bring new manufacturing to the United States, Breen expects additional spend of $2 billion for each new "green field" site and a five-year runway to production.

EU medical and pharmaceutical product exports to the U.S. totaled about 90 billion euros ($97 billion) in 2023, according to latest Eurostat data.

Shares of AstraZeneca AZN.L, GSK GSK.L, Roche ROG.S, Sanofi SASY.PA and Novartis NOVN.S fell between 5% and 6.5% in Europe. Meanwhile, Indian pharmaceutical stocks .NIPHARM closed nearly 2% lower, dragging down the benchmark Nifty 50 .NSEI by 0.6%.

IPCA Laboratories IPCA.NS, Glenmark Pharma GLEN.NS and Biocon BION.NS were the top losers by percentage on the pharma index in Mumbai, ending the trading session between 4% and 5.5% lower.

India's pharma exports to the U.S. mostly comprise generics, or cheaper versions of popular drugs. The United States accounts for a third of India's overall pharma exports.

(Reporting by Kashish Tandon, Ananta Agarwal and Manas Mishra in Bengaluru and Anna Pruchnicka in Gdansk; Editing by Savio D'Souza, Mrigank Dhaniwala and Shounak Dasgupta)

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

• APPROVES ISSUANCE OF COMMERCIAL PAPERS UP TO 6 BILLION RUPEES

Source text: ID:nBSE2jScWY

Further company coverage: BION.NS

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April 1 (Reuters) - Biocon Ltd BION.NS:

• BIOCON LTD - TO CONSIDER FUND RAISING THROUGH COMMERCIAL PAPERS ON APRIL 4, 2025

Source text: ID:nBSE5rghRV

Further company coverage: BION.NS

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

• UNIT GETS APPROVAL FROM THE U.S. FDA FOR ITS ANDA NOREPINEPHRINE BITARTRATE INJECTION

Source text: [ID:]

Further company coverage: BION.NS

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