BIOCON

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

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

Source text: [ID:]

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March 20 (Reuters) - Eli Lilly LLY.N on Thursday launched in India its diabetes and weight-loss drug, Mounjaro, which has already clocked in over $20 billion in global sales since its initial U.S. launch in 2022.

India, the world's most populous country, has high obesity rates and the second-highest number of people with type 2 diabetes. Around 11% of Indian adults are expected to become obese by 2035, according to the World Obesity Federation Atlas.

Here are the local and international drugmakers also eyeing the Indian market and looking to introduce rivals to Lilly's drug:

NOVO NORDISK

The Danish drugmaker NOVOb.CO had said it aims to launch its blockbuster weight-loss drug, Wegovy, in India by 2026.

The active ingredient in Wegovy is semaglutide, which is likely to go off-patent in 2026 in India.

Wegovy and Lilly's Mounjaro belong to the same class of treatments called GLP-1 agonists, which soared into popularity globally triggering a shortage of supply. GLP-1 drugs mimic a gut hormone that helps control blood sugar levels and slow digestion, making people feel fuller for longer.

SUN PHARMA

Sun Pharmaceutical SUN.NS, India's largest drugmaker by revenue, is developing its own GLP-1 treatment, utreglutide, for weight loss and type 2 diabetes.

The drugmaker said earlier this month it expects to launch the drug in the next four to five years.

BIOCON

Indian drugmaker Biocon BION.NS is developing its own version of Novo's Wegovy, as the drug is set to lose exclusivity next year in emerging markets such as India, Brazil, Mexico, and Saudi Arabia.

ZYDUS LIFESCIENCES

India's Zydus Lifesciences ZYDU.NS is developing the generic version of Semaglutide and plans on launching the drug after its patent expires in India.

CIPLA

Cipla CIPL.NS, India's third-largest drugmaker by sales, is among the Indian drugmakers making cheaper versions of Novo's Wegovy.

Cipla has also said it is open to partnering with Lilly to market Mounjaro in India.

DR. REDDY'S

India's Dr. Reddy's REDY.NS has said it plans to launch generic versions of Semaglutide in all the markets as Novo's patent expires.

LUPIN

India's Lupin LUPN.NS is another generic drugmaker looking to grab a share of the burgeoning obesity treatment market with its own version of Novo's Wegovy.

NATCO, MANKIND PHARMA, AUROBINDO PHARMA

Media reports say India's Natco Pharma NATP.NS, Mankind Pharma MNKI.NS, Aurobindo Pharma ARBN.NS are also developing cheaper versions of Novo's Wegovy.

Reuters was not able to independently verify the reports.

(Reporting by Mariam Sunny in Bengaluru; Editing by Maju Samuel)

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Corrects deal value in headline, paragraph 1 to $36.5 million, from $50 million

March 10 (Reuters) - India's Syngene International on Monday said it has acquired its first biologics facility in the United States from Emergent Manufacturing Operations Baltimore, a unit of Emergent BioSolutions EBS.N, for $36.5 million.

The contract research firm's acquisition of the facility aligns with broader industry efforts to reduce dependence on China by expanding capabilities in other regions.

The facility, which the contract research firm said is strategically located near key biotech hubs in the Northeast U.S., is expected to be operational for client projects from the second half of 2025.

This acquisition, expected to close in March 2025, will boost Syngene's total single-use bioreactor capacity to 50,000 liters from 20,000 liters, enhancing its capabilities in large molecule discovery, development and manufacturing services.

"In the short term, we expect minor dilution of operating margins as a result of costs to be incurred in this facility," Deepak Jain, Syngene International's chief financial officer, said.

India's contract research development and manufacturing organisation sector has the potential to grow seven-fold to $22 billion-$25 billion by 2035, according to a report by Boston Consulting Group.

(Reporting by Yagnoseni Das in Bengaluru; Editing by Vijay Kishore)

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

• BIOCON BIOLOGICS ANNOUNCES POSITIVE RESULTS FROM PHASE 3 STUDY OF YESINTEK™ BIOSIMILAR TO USTEKINUMAB FOR CHRONIC PLAQUE PSORIASIS

• BIOCON LTD - YESINTEK DEMONSTRATES EQUIVALENT EFFICACY AND SAFETY TO STELARA

Source text: ID:nPn6k3Q9ta

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

• BIOCON BIOLOGICS AND CIVICA, INC. COLLABORATE TO EXPAND INSULIN ASPART ACCESS IN US

Source text: ID:nBSE484mXh

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

• BIOCON - SUBSIDIARY RECEIVED FINAL APPROVALS FOR ITS ANDAS FROM U.S. FDA

• BIOCON - APPROVALS FOR LENALIDOMIDE CAPSULES, DASATINIB TABLETS

• BIOCON - BIOCON PHARM RECEIVED TENTATIVE APPROVAL FOR RIVAROXABAN TABLETS

Source text: ID:nBSE1Z652g

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

• LAUNCHES GLP-1 PEPTIDE LIRAGLUTIDE IN THE U.K.

Source text: ID:nBSE6zTWvJ

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** Shares of Biocon BION.NS rise nearly 2%, set to snap 7-day losing run

** Biopharma co says unit launches YESINTEK, a biosimilar to Stelara, in the U.S. to treat chronic autoimmune diseases

** Analysts avg rating is 'buy'; median PT is 400 rupees vs current price of 327 rupees -LSEG data

** BION shed nearly 11% in 7-day losing streak and is down about 12% YTD

(Reporting by Meenakshi Maidas in Bengaluru)

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

• BIOCON LTD - BIOLOGICS LAUNCHES YESINTEK BIOSIMILAR IN THE U.S.

Source text: ID:nBSEbJSdHv

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Feb 18 (Reuters) - Biocon Ltd BION.NS:

• EUROPEAN COMMISSION APPROVES BIOCON BIOLOGICS’ USTEKINUMAB BIOSIMILAR

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

• EQUILLIUM ANNOUNCES POSITIVE DATA FROM PHASE 2 STUDY EVALUATING ITOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

• EQUILLIUM INC - ITOLIZUMAB GENERALLY WELL TOLERATED IN PHASE 2 STUDY

• EQUILLIUM INC - ITOLIZUMAB ACHIEVES 16.7% ENDOSCOPIC REMISSION IN PHASE 2 STUDY

Source text: ID:nBwbcr7K5a

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Repeats with no change to text or headline

By Rishika Sadam

HYDERABAD, Jan 31 (Reuters) - Indian biopharmaceutical firm Biocon BION.NS is likely to list its key biosimilars business by March 2026 and aims for double-digit share in its core U.S. market for its new launches, a top executive told Reuters on Friday.

The company plans to launch five new biosimilars in the U.S. in the new fiscal year, starting in April, and is aspiring for double-digit market share for them, Biocon Biologics CEO Shreehas Tambe told Reuters in an interview.

Biosimilars are similar and relatively affordable versions of high-priced and complex biologics drugs used to treat illnesses such as cancer and autoimmune diseases.

"We needed to be in charge and control of the business (before taking the company public). I think we're pretty much there... We should be looking at the next 12-15 months to this fiscal, which is March 2026 (for listing)," Tambe said.

The company, which has been pushing its IPO plans for the past year, has been waiting to complete the integration of its acquired biosimilars firm Viatris and refinance debt before it goes public.

The new U.S. launches, in addition to four existing biosimilars, will focus on therapy areas including diabetes, oncology and immunotherapy.

The company's existing biisimilars have a 20% market share, Tambe said.

The U.S. contributes about 40% in revenue to Biocon Biologics, followed by 35% from Europe where the company plans to launch three new biosimilars in the next 18 months.

The firm hopes to benefit from U.S. President Donald Trump's stand on healthcare affordability, Tambe said.

"..there is a bipartisan view on on bringing affordability to healthcare and I think biosimilars have a big role to play in this," he said.

(Reporting by Rishika Sadam; Editing by Sonia Cheema)

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By Rishika Sadam

HYDERABAD, Jan 31 (Reuters) - Indian biopharmaceutical firm Biocon BION.NS is likely to list its key biosimilars business by March 2026 and aims for double-digit share in its core U.S. market for its new launches, a top executive told Reuters on Friday.

The company plans to launch five new biosimilars in the U.S. in the new fiscal year, starting in April, and is aspiring for double-digit market share for them, Biocon Biologics CEO Shreehas Tambe told Reuters in an interview.

Biosimilars are similar and relatively affordable versions of high-priced and complex biologics drugs used to treat illnesses such as cancer and autoimmune diseases.

"We needed to be in charge and control of the business (before taking the company public). I think we're pretty much there... We should be looking at the next 12-15 months to this fiscal, which is March 2026 (for listing)," Tambe said.

The company, which has been pushing its IPO plans for the past year, has been waiting to complete the integration of its acquired biosimilars firm Viatris and refinance debt before it goes public.

The new U.S. launches, in addition to four existing biosimilars, will focus on therapy areas including diabetes, oncology and immunotherapy.

The company's existing biisimilars have a 20% market share, Tambe said.

The U.S. contributes about 40% in revenue to Biocon Biologics, followed by 35% from Europe where the company plans to launch three new biosimilars in the next 18 months.

The firm hopes to benefit from U.S. President Donald Trump's stand on healthcare affordability, Tambe said.

"..there is a bipartisan view on on bringing affordability to healthcare and I think biosimilars have a big role to play in this," he said.

(Reporting by Rishika Sadam; Editing by Sonia Cheema)

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HYDERABAD, Jan 30 (Reuters) - Indian biopharma company Biocon BION.NS reported third-quarter revenue on Thursday that fell about 3% when compared with the year-earlier period, which included revenue from its domestic branded formulation business that has since been divested.

The Bengaluru-based company, which counts the U.S. as its key market, reported revenue from operations of 38.2 billion rupees ($441.39 million) for the quarter, compared with 39.54 billion rupees a year earlier.

Revenue from Biocon's biosimilars business, its largest, fell 7.9% to 22.9 billion rupees. Biosimilars are copies of high-priced drugs used to treat illnesses such as rheumatoid arthritis and cancer.

After adjustments, the company's revenue from operations rose 10% on a like-for-like basis, according to Biocon.

Its generics division, however, has been under pressure due to pricing challenges and a planned facility shutdown, the company said in November.

Revenue from the generics unit fell 2.4%, while revenue from its research services business rose 11%.

Biocon, which expects a recovery in its generics business in the next few quarters, is banking on its portfolio of obesity drugs, which have seen skyrocketing demand in global markets.

The company reported a consolidated net profit of 251 million rupees in the third quarter, compared with 6.6 billion rupees a year earlier when it had recorded gains related to dilution of Biocon's stake in its associate company Bicara and the divestment of its domestic formulation business.

The company's quarterly results were also impacted due to tax expenses, Biocon said.

The company increased its equity shareholding in its biologics unit by 1.5% for 5.6 billion rupees and expects the purchase to be completed by next month.

($1 = 86.5450 Indian rupees)

(Reporting by Rishika Sadam in Hyderabad; Editing by Shounak Dasgupta)

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Jan 29 (Reuters) - Biocon Ltd BION.NS:

• ISSUE OF COMMERCIAL PAPERS OF 5.7 BILLION RUPEES

Source text: ID:nBSE6VMDF8

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

• APPROVES ISSUANCE OF COMMERCIAL PAPERS WORTH 5.70 BILLION RUPEES

• COMMERCIAL PAPERS ISSUANCE ON PRIVATE PLACEMENT BASIS

Source text: ID:nNSEbcHMmj

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BENGALURU, Jan 23 (Reuters) - Diary of India economic, corporate events on Jan. 23

ECONOMIC, CORPORATE .BSE500 EVENTS:

NTS - 'No time scheduled', AMC - 'After market close'

(Compiled by Bengaluru Newsroom)

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Corrects to remove reference to cosmetic surgeries in paragraph 2

By Rishika Sadam

HYDERABAD, India, Jan 20 (Reuters) - India should eliminate tax on drugs for cancer treatment and for chronic and rare diseases, the chairperson of major drugmaker Biocon Ltd BION.NS said ahead of Prime Minister Narendra Modi's budget announcement, expected next month.

Drugs used for treating chronic diseases such as diabetes and cancer should be exempted from tax, Kiran Mazumdar-Shaw told Reuters on Friday.

"In India most of the expenses on medicines are out of pocket - even diagnostic scans are very expensive," she said, urging the government to consider making lifesaving therapies affordable and waiving tax on them.

"All cancer-related drugs are expensive. Any drug used for chronic therapy with a monthly cost of treatment exceeding 5,000 rupees ($60) should also be exempted from tax," Mazumdar-Shaw said.

Calls to government representatives over the weekend seeking comment went unanswered. The government in July exempted three cancer drugs from customs duty and slashed taxes on some of them.

There is usually a 12% tax on medication for chronic diseases, said Rajiv Singhal, general secretary of the All India Organisation of Chemists and Druggists.

"In a price-sensitive market like India, the tax is a burden on the patient. Government should not look at profitability when it comes to medicines which are not a luxury," he said.

To make cancer care more affordable in price-sensitive India, Mazumdar-Shaw said, the government must also cut import duties for high-tech instruments, input materials and consumables used to develop life-saving precision medicines.

"This will make a big difference to patients," she said. India's import tax on medical equipment is as high as 36%.

Mazumdar-Shaw's Immuneel Therapeutics startup is working on providing cell therapy.

India's pharmaceutical industry, which counts the U.S. as one of its largest markets, hopes to take advantage of expected trade tension between China and the administration of Donald Trump, who retakes the White House on Monday.

"I think the Trump administration is unlikely to take a strong anti-China stance because they realise that they are dependent on China for many things," Mazumdar-Shaw said, adding that India stands to gain as countries look to limit their reliance on China after COVID-19.

($1 = 86.5710 Indian rupees)

(Reporting by Rishika Sadam; Editing by William Mallard)

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** Shares of Biocon BION.NS rise 3.3% to 377 rupees; top gainer on Nifty Pharma Index .NIPHARM, which is up 0.44%

** HSBC Global Research upgrades bio-pharma firm's stock to "Buy" from "Reduce"; hikes PT to 430 rupees (~$5) from 290 rupees

** The brokerage says it expects operational turnaround in BION led by key biosimalars launches and recovery in generics sales

** HSBC hikes FY26 and FY27 earnings per share estimates by 21.3% and 34.8%, respectively

** Sees better market share gains for biosimilar launches and recovery in rev growth for generics segment on high-value launches

** Nine of 16 analysts covering BION have "Buy" or "Strong Buy" rating, 3 have "Hold", while 4 have "Sell" or "Strong Sell"; median PT is 372.5 rupees - LSEG data

** Stock gained 46% in 2024 vs NIPHARM's 39% jump

($1 = 86.5260 Indian rupees)

(Reporting by Ashna Teresa Britto in Bengaluru)

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** Biocon BION.NS rise as much as 4.4% to 377 rupees, set to snap a three-session losing run

** US FDA clears Biocon's Malaysia unit

** BofA says India facility clearance last qtr and Malaysia now should lift confidence in biosimilar launch pipeline

** BofA hikes PT to 435 rupees from 400 rupees; keeps "buy"

** Motilal Oswal upgrades to "buy" from "neutral"

** 16 analysts avg rating is "hold" and median PT is 357.5 rupees -LSEG data

** About 8 mln shares traded, 2.3x its 30-day moving avg

** BION gained 46.3% in 2024

(Reporting by Anuran Sadhu in Bengaluru)

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Updates

** Shares of Biocon BION.NS rise as much as 8.6% to 389 rupees, highest since Sept. 17

** Stock top gainer on Nifty Pharma Index .NIPHARM, which is up 1.02%

** Co says its biosimilars unit Biocon Biologics has received Japan's Pharmaceuticals and Medical Devices Agency's (PMDA) approval for Ustekinumab BS subcutaneous injection

** Ustekinumab BS is used to treat psoriasis vulgaris and psoriatic arthritis, and is a biosimilar to Stelara

** Growth visibility for biologics business has surged post U.S. FDA clearance of Bengaluru Biologics plant, Jefferies analysts say

** Jefferies hikes PT on stock to 400 rupees from 280 rupees; upgrades rating to "hold" from "underperform"

** 16 analysts covering the stock on avg have a "Hold" rating; median PT is 350 rupees - LSEG

** Stock rose 46% in 2024 vs a 39% jump in pharma index

(Reporting by Ashna Teresa Britto in Bengaluru)

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

• BIOCON - BIOCON PHARMA RECEIVED APPROVAL FOR TACROLIMUS CAPSULE

• BIOCON - GOT APPROVAL FOR TACROLIMUS CAPSULE FROM CHINA AUTHORITY

Source text: ID:nnAZN3004S8

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

• BIOCON LTD - BIOLOGICS FULFILLS OBLIGATIONS UNDER VIATRIS ACQUISITION AGREEMENT

• BIOCON LTD - BIOLOGICS COMPLETES FINAL REMITTANCE FOR VIATRIS ACQUISITION

Source text: ID:nNSE1JPPyb

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

• CO, ZENTIVA, GETS DECENTRALIZED PROCEDURE (DCP) APPROVAL

• GETS DCP APPROVAL FOR LIRAGLUTIDE IN EU

Source text: ID:nBSE7NTfxQ

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

• SELLS 8 MILLION EQUITY SHARES OF SYNGENE INTERNATIONAL THROUGH BLOCK DEAL

• SHAREHOLDING IN SYNGENE NOW AT 52.46%

• RECEIVES APPROXIMATELY 6.86 BILLION RUPEES FROM SALE

Source text: ID:nBSE5j8PXC

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** Shares of biopharma firm Biocon BION.NS climb 2.6% to 374.7 rupees after the U.S. FDA approved its drug YESINTEK

** YESINTEK is a biosimilar drug to Johnson & Johnson's JNJ.N Stelara and is used to treat skin disease psoriasis

** BION hits highest in nearly ten weeks

** Stock eyes busiest trading day in 13 sessions, over 6.7 mln shares traded

** Analysts' avg rating on stock is "Hold", median PT is 334.5 rupees, per LSEG data

** Stock up 50% YTD, on track to snap three straight years of losses

(Reporting by Manvi Pant in Bengaluru)

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** Biocon BION.NS climbs ~6% to 340.20 rupees

** US FDA completes inspection of drugmaker's manufacturing site in Bengaluru, classifies it as "voluntary action indicated"

** VAI indicates the agency is not prepared to take or recommend any administrative or regulatory action, per the FDA website

** Stock top pct gainer on pharma index .NIPHARM, which down 0.3%

** Trading volume ~3x the 30-day avg

** BION rated "hold" on avg; median PT is 317 rupees - LSEG

** Stock climbs ~36% YTD vs pharma index's ~34% gain

(Reporting by Kashish Tandon in Bengaluru)

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** Biocon BION.NS falls as much as 5.5% to 303 rupees, lowest since June 5

** Biopharmaceutical co swings to Q2 loss on higher taxes paid

** Jefferies says BION's Q2 results were a miss on already subdued expectations

** Cuts FY26 EBITDA by 2% but raises FY27 EBITDA by 7% to factor in contribution from biosimilars bEyelea/bStelara

** Five of 16 analysts have cut their PT since results on Wednesday; four have raised their targets - LSEG

** Median PT now 317 rupees, down 5.4% from Sept.

** Stock top pct loser on Nifty pharma index .NIPHARM, which is up 1.5%

** More than 9.6 mln shares traded, 2.9x the 30-day avg

** Stock up 25.8% YTD

(Reporting by Ashish Chandra in Bengaluru)

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HYDERABAD/BENGALURU Oct 30 (Reuters) - Indian biopharmaceutical firm Biocon BION.NS swung to a quarterly loss on higher taxes paid, it said on Wednesday.

Net loss attributable to shareholders was 160 million rupees ($1.90 million) for the quarter ended Sept. 30, against a profit of 1.26 billion rupees a year ago.

After adjusting for exceptional items, the loss was around 130 million rupees, while the profit before tax was 720 million rupees, Biocon said.

"Reported net loss for the quarter.. (was) on account of higher tax, based on geographical split of profits and minority interest," Group Chief Executive Officer Peter Bains said.

Biocon incurred a 200 million rupee deferred tax charge on withdrawal of indexation benefit during the quarter.

Its revenue from operations rose 3.7% to 35.9 billion rupees, boosted by strong sales of its biosimilars business in key markets United States and Europe. The business, its biggest, posted a 11% rise in revenue.

Biosimilars are copies of costlier biological drugs for treating major illnesses such as cancer, rheumatoid arthritis and psoriasis.

Revenue from generic drugs business, however, fell 7.7% hurt by lower pricing and stiff competition, especially in U.S. and due to a planned shut down of one of its manufacturing facilities, the company said.

Biocon is banking on its anti-obesity drugs to enable mid and long-term growth in the business.

Indian drugmakers including Biocon are working on versions of popular weight-loss drugs such as Wegovy, by Danish drugmaker Novo Nordisk NOVOb.CO, which have seen skyrocketing demand in global markets which companies such as Novo and Eli Lilly LLY.N have struggled to keep up with.

($1 = 84.0640 Indian rupees)

(Reporting by Rishika Sadam and Kashish Tandon in Bengaluru; Editing by Mrigank Dhaniwala)

((rishika.sadam@thomsonreuters.com;))

Sept 26 (Reuters) - Biocon Ltd BION.NS:

• BIOCON - PARTNERS WITH TABUK PHARMACEUTICALS

• BIOCON - PARTNERSHIP TO COMMERCIALIZE GLUCAGON-LIKE PEPTIDE-1 (GLP -1) PRODUCTS IN MIDDLE EAST

Source text for Eikon: ID:nBSEbNVtmT

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