Page 2 - Biocon

USFDA's new biosimilar norms to woo more players, fast-track mkt entry

Indian cos like Biocon, DRL, Intas, Lupin stand to benefit from the proposed move

Biocon Biologics gets Health Canada approval for Yesintek, Yesintek I.V.

The approval of Yesintek and Yesintek I.V., biosimilars to Stelara, strengthens Biocon Biologics' presence in North America and expands its immunology portfolio

Biocon gets Health Canada nod for biosimilars Yesintek, Yesintek IV

Biocon Ltd on Thursday said its arm Biocon Biologics Ltd has received an approval from Health Canada for chronic autoimmune conditions treatment medications Yesintek and Yesintek IV. The notice of compliance (NOC) granted by Health Canada is for Yesintek (ustekinumab injection) and Yesintek IV (ustekinumab for injection, solution for intravenous infusion), Biocon Ltd said in a regulatory filing. Yesintek and Yesintek IV are biosimilars to Stelara (ustekinumab injection) and Stelara IV (ustekinumab for injection, solution for intravenous infusion), respectively. The approval was granted on October 17, paving the way for Canadian commercial availability in mid-October, the company said. "Health Canada's approval of Yesintek marks a significant milestone in our mission to expand global access to high-quality biosimilars," Biocon Biologics CEO & Managing Director Shreehas Tambe said. He further said, "Building on our successful US launch, this approval strengthens our presence in ...

Biocon chief Kiran Mazumdar-Shaw meets CM Siddaramaiah, deputy CM on Diwali

Biocon chief Kiran Mazumdar-Shaw on Tuesday met Chief Minister Siddaramaiah and his deputy D K Shivakumar and greeted them on the occasion of Diwali, official sources said. Shaw has been critical of Bengaluru's infrastructure woes by highlighting them through her social media posts, and has been repeatedly urging the state government to intervene. "Biocon chief Kiran Muzumdar-Shaw visited Cauvery (CM's official residence) and wished Chief Minister Siddaramaiah on Diwali. Legislative Council Chairman Basavaraj Horatti was present on the occasion," the CM's office said in a statement. Shah met Shivakumar at his Sadashivanagar residence in Bengaluru, the Deputy CM's office said. The state government has come under criticism over the poor state of roads and traffic issues in the city for some time now, with industry veterans like former Infosys CFO Mohandas Pai and Shaw repeatedly openly urging the state government to immediately intervene. Faced with mounting criticism from industry

Here's why Biocon shares were trading higher on the bourses on October 20

Biocon Biologics, a fully integrated global biosimilars company and a subsidiary of Biocon, announced the expansion of its strategic collaboration with Civica, Inc. (Civica)

Biocon Biologics expands Civica tie-up to launch pvt-label insulin in US

The move aims to increase the availability of affordable insulin for the country's 38.4 million diabetes patient

Biocon's Kiran Mazumdar-Shaw flags Bengaluru road woes; minister responds

Responding to Shaw's criticism, Karnataka minister Priyank Kharge said he was unsure which part of Bengaluru her overseas visitor has seen

Biocon gets USFDA's tentative approval for antibacterial drug Rifaximin

The USFDA's tentative approval means Biocon Pharma's Rifaximin 550 mg meets regulatory requirements but cannot be marketed in the US yet due to patents or exclusivity on the original drug

Biocon inks settlement, license pact with Amgen to market biosimilars in US

Biotechnology firm Biocon on Wednesday said its unit has inked a settlement and license agreement with Amgen Inc., paving the way for commercialisation of two biosimilars used in the treatment of osteoporosis and cancer-related bone conditions. Biocon Biologics has inked the pact with Amgen Inc for the commercialisation of Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq) in the US, the company said in a regulatory filing. Bosaya 60 mg/mL injection in a single-dose prefilled syringe (PFS) and Aukelso 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial are biosimilars to Amgen's Prolia and Xgeva, respectively. These products are used in the treatment of osteoporosis and cancer-related bone conditions. Biocon Biologics and Amgen executed the settlement agreement to resolve the pending patent litigation at the US District Court for the District of New Jersey, the Bengaluru-based firm said. The agreement enables Biocon Biologics to launch Bosaya and Aukels

Biocon Biologics secures USFDA approval for Bosaya and Aukelso biosimilars

Biocon Biologics gets USFDA approval for Bosaya and Aukelso, denosumab biosimilars of Prolia and Xgeva, with provisional interchangeability status to widen patient access

Biocon expands US footprint with new Cranbury manufacturing facility

Biocon inaugurated its first US manufacturing facility in Cranbury through Biocon Generics, expanding its global footprint and strengthening supply chains for essential therapies

Biocon inaugurates first manufacturing facility in New Jersey's Cranbury

Biocon Ltd on Thursday said it has inaugurated its first manufacturing facility in the US, located in Cranbury, New Jersey. The company's wholly-owned subsidiary, Biocon Generics Inc. (BGI), operates the plant. Biocon acquired the Oral Solid Dosage (OSD) facility from Eywa Pharma Inc in 2023 and has since invested over USD 30 million to establish a plant with an annual production capacity of 2 billion tablets. A few products have already been commercialised from the site, with several more in the pipeline, the Bengaluru-based firm said in a statement. This investment helps Biocon diversify its manufacturing base, strengthen its supply chain and accelerate the expansion of its global footprint, it added. "Biocon's first USFDA-approved formulations facility in New Jersey marks a new chapter in our journey of global expansion," Kiran Mazumdar-Shaw, Chairperson of Biocon Group, said. The facility reflects the company's long-term commitment to deeper engagement with healthcare provide

Stocks to watch today, Sep 11: Bajaj Finserv, DRL, Mazagon, Jupiter Wagons

Stocks to watch on Thursday, September 11: Keystone Realtors, RVNL, Deepak Fertilisers, Torrent Pharma and Adani Ports are among top stocks to track today.

Biocon shares gain 2% after USFDA inspection at Bengaluru facility; details

The inspection covered various aspects of operations including drug substance manufacturing units, analytical quality control laboratories, microbiology laboratories, and warehouses

India Inc's earnings pulse weakens after Q1: Top 5 EPS upgrades, downgrades

Brokerages trim FY26 estimates for 130 of 192 BSE 200 companies, with a median EPS downgrade of 3.5%

India Inc bonds resilient amid record trade costs from US tariffs: Barclays

Barclays says Indian corporates will face margin compression but remain supported by strong leverage, liquidity and domestic demand as US tariffs hit $55 bn exports

Biocon shares slip 3% as Q1 results miss estimates; should you sell?

Biocon shares fell 3 per cent after it reported a 95.2 per cent decline in net profit in Q1FY26

Confident about Biocon's response to US tariffs: Kiran Mazumdar-Shaw

We remain confident in our global footprint and are well positioned to respond once more details are available. , said Biocon Chairperson

Stocks to Watch today, Aug 8: Titan, BSE, Biocon, LIC, Godrej Consumer

Stocks to Watch today, August 8, 2025: Titan, BSE, LIC, Godrej Consumer Products, and Biocon are some of the key stocks to watch today

Biocon Q1 results: Net profit down 95%, revenue rises 15% to ₹4,022 cr

Biocon's Q1 net profit declines sharply due to high base from one-time gain last year; biosimilars, CRDMO and generics drive revenue and operational growth