BIOCON

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)

(([email protected];))

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

(([email protected];))

** 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)

(([email protected];))

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)

(([email protected];))

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

• BIOCON -

• BIOCON BIOLOGICS' YESAFILI® (AFLIBERCEPT) NOW PUBLICLY FUNDED IN ONTARIO, CANADA FOR THE ADVANCED TREATMENT OF PATIENTS WITH RETINAL DISEASES

Source text: ID:nCNWtmTYZa

Further company coverage: BION.NS

(([email protected];))

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

(([email protected];))

** 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)

(([email protected]))

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

(([email protected];;))

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

(([email protected];))

** 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)

(([email protected]))

July 15 (Reuters) - FDA:

• US FDA APPROVES BIOCON BIOLOGICS BLA FOR KIRSTY

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

(((( [email protected] ;));))

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

(([email protected];;))

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

(([email protected];))

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

• BIOCON - BIOCON BIOLOGICS EXPANDS INSULIN ACCESS IN MALAYSIA

Source text: ID:nNSE3PN7yT

Further company coverage: BION.NS

(([email protected];))

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)

(([email protected]; 65 6870 3026; Reuters Messaging: [email protected]))

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

• RAISES 45 BILLION RUPEES THROUGH QIP

Source text: ID:nBSE1N5x1G

Further company coverage: BION.NS

(([email protected];;))

** 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)

(([email protected]; +91 9769003463;))

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

(([email protected];;))

BENGALURU, May 8 (Reuters) - Diary of India economic, corporate events on May 8

ECONOMIC, CORPORATE .BSE500 EVENTS:

NTS - 'No time scheduled'

(Compiled by Bengaluru Newsroom)

(([email protected]))

May 5 (Reuters) - Biocon Ltd BION.NS:

• BIOCON BIOLOGICS SECURES STRONG MARKET ACCESS COVERAGE FOR YESINTEK IN THE UNITED STATES

Source text: ID:nBSE8NV3PQ

Further company coverage: BION.NS

(([email protected];;))

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

(([email protected];;))

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

(([email protected];))

** 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)

(([email protected];))

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

(([email protected];))

April 9 (Reuters) - Indian pharmaceutical stocks .NIPHARM fell 1.7% on Wednesday after U.S. President Donald Trump reiterated plans to announce a "major" tariff on all pharmaceutical imports.

U.S. accounts for a third of India's overall pharma exports.

Trump also threatened the duties on Friday, after his first set of reciprocal tariffs earlier last week exempted pharma products -- a change in stance that had prompted a wild swing in pharma stocks.

On the day, all twenty constituents of the pharma index were lower, with the index dragging down the benchmark Nifty 50 .NSEI by about 0.52% as of 9:20 a.m. IST.

Gland Pharma GLAD.NS, Lupin LUPN.NS and Zydus Lifesciences ZYDU.NS were the top losers by percentage, down between 3% and 5%.

Sun Pharma SUN.NS and Cipla CIPL.NS, the top constituents by weight, fell 1.69% and 1.87%, respectively.

India's pharma exports to the U.S. mostly comprise generics, or cheaper versions of popular drugs. These currently attract almost no U.S. levies, while India imposes about 10% tax on U.S. pharma imports, according to industry experts.

The pharma index has fallen 14.4% this year.

(Reporting by Kashish Tandon and Ananta Agarwal in Bengaluru; Editing by Savio D'Souza)

(([email protected];))

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

(([email protected];))

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

(([email protected];))

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

(([email protected];;))

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)

(([email protected];))

Adds details from Emergent's statement in paragraphs 4 & 7, background in paragraphs 5&6

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 in India to reduce dependence on China by expanding capabilities in other regions.

The Baltimore-Bayview 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.

As part of the agreement, Emergent said it will retain the rights to secure manufacturing services and capacity at the facility in collaboration with Syngene.

Emergent shut the facility last year as part of its ongoing efforts to cut costs and pivot away from contract manufacturing business as a funding crunch forced its smaller biotech clients to cut back on research spending.

Emergent also faced quality issues at the plant during the pandemic while producing Johnson & Johnson's JNJ.N COVID-19 vaccine.

However, the U.S. drugmaker said the U.S. Food and Drug Administration cleared the facility last year and is now in compliance with the required guidelines.

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 and Mariam Sunny in Bengaluru; Editing by Vijay Kishore)

(([email protected];))