Latest news with #ShreehasTambe
Mint
12-05-2025
- Business
- Mint
Biocon to evaluate merger with subsidiary Biologics
Biocon Group's board is setting up a committee to evaluate strategic restructuring options, including a merger of its biosimilars arm Biocon Biologics Ltd with its flagship Biocon Ltd. The options would be evaluated taking into consideration matters relating to legal and tax aspects and subject to all approvals, including regulatory, board and shareholders, the company said in a release dated 8 May. The company had said in February that it would likely list its biosimilars business on the stock exchanges by March 2026. Also read: Biocon share price jumps 4% as subsidiary secures market entry for Yesafili in US '…given the market volatility that we are seeing on the IPO front, the board was of the opinion that we should look at other strategic options which also be includes evaluating a merger," Kiran Mazumdar-Shaw, chairperson, Biocon Group, told investors in an earnings call on Friday. "So at this point in time the board has constituted a committee, we will evaluate all strategic options and then get back to you in a few months with what the committee recommends to the board," she added. Biocon's board also approved raising up to ₹4,500 crore by way of issue of securities via qualified institutional placements, rights issue or other permissible routes, the company said. The funds will be used for repaying borrowings by the company or its subsidiaries, fulfilling other debt obligations, as well as investments in subsidiaries. Also read: All India Chemists and Druggists association urges members to ensure adequate stock supplies in border states Biocon Biologics acquired US drugmaker Viatris' global biosimilars business in 2022 to expand its global footprint. The company's CEO and managing director Shreehas Tambe had previously said it would consider an IPO after it completed the integration of the Viatris portfolio. 'On a full-year basis, the company has recorded a strong 15% growth in FY25 and we have successfully consolidated our business worldwide," Tambe said in the release. 'Having built a strong foundation, we are well-positioned to launch 5 new products in the next 12-18 months and expand patient access." Biocon is a global biopharmaceuticals company which has developed and commercialised novel biologics, biosimilars and complex small molecule active pharma ingredients (APIs) in India and several key global markets, as well as generic formulations in the US, Europe and emerging markets. The company is focused on complex therapies in chronic segments like diabetes, cancer and autoimmune. Also read: Donald Trump announces 59% cuts in US prescription drug prices, one day after new pharma policy Biocon Biologics' four biosimilars recorded sales of $200 million each in FY25. The company also launched its fifth biosimilar product, Yesinket (Ustekinumab), in the US in FY25.
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Business Standard
05-05-2025
- Business
- Business Standard
Biocon Biologics secures multiple market access coverage for Yesintek in US
Biocon Biologics, a subsidiary of Biocon, on Monday said that it has secured multiple market access agreements for Yesintek in the US, its biosimilar which resembles the properties of Stelara. Clinical trials confirmed that Yesintek demonstrated comparable pharmacokinetics, safety, efficacy, and immunogenicity. A biosimilar is a biological medicine that is highly similar to an already approved biological medicine, also known as the reference product. Pharmacy benefit management firms like US-based Express Script have added Yesintek to the National Preferred Formulary (NPF) effective March 21. US healthcare multinational Cigna has also added Yesintek to its commercial formulary beginning on March 21. Yesintek has been approved for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis, offering patients more affordable options for managing these common chronic autoimmune conditions. It is available in the same formulations as Stelara. Additionally, Yesintek has been selected as the exclusive Ustekinumab by Blue Cross Blue Shield of Michigan (BCBSM), Florida Healthcare Plan, and several closed-door health systems. The company is also finalising formulary agreements with other commercial carriers, Biocon said in an exchange filing. The available dosages include 45 mg/0.5 mL prefilled syringe, 90 mg/mL prefilled syringe, 45 mg/0.5 mL vial, and 130 mg/26 mL vial. The US Food and Drug Administration (FDA) approved Yesintek in December 2024. 'Yesintek represents an important milestone for Biocon Biologics, as this is the first product we have launched in the United States as a fully integrated biosimilars company. The listing of Yesintek on multiple formularies is another validation that payors in the US are committed to broadening access to affordable treatment options,' said Shreehas Tambe, CEO & managing director at Biocon Biologics. Josh Salsi, head of North America at Biocon Biologics said, over 100 million Americans – representing 70 to 80 per cent of the commercial market – are now covered for Yesintek through commercial formularies.
Business Standard
05-05-2025
- Business
- Business Standard
Biocon edges higher after biologics arm secures multiple market access deals for Yesintek
Biocon advanced 3.17% to Rs 328.75 after Biocon Biologics (BBL) secures multiple market access agreements in the United States for Yesintek (ustekinumab-kfce), its biosimilar to Stelara (ustekinumab), covering over 100 million lives. These agreements include key placements on national and regional formularies. Express Scripts added Yesintek to its National Preferred Formulary (NPF) effective 21 March 2025. Cigna included Yesintek on its commercial formulary starting 21 March 2025. UnitedHealthcare has added Yesintek to various formularies: commercial from 01 May 2025; managed Medicaid from 01 March 2025; and Medicare from 01 June 2025. CVS Health will include Yesintek beginning 01 July 2025, and Optum Rx will add it to its premium and select formularies from 01 July 2025. Furthermore, Yesintek has been selected on formularies by Navitus, Costco Health Solutions, MedImpact, Priority Health, University of Pittsburgh Medical Center (UPMC), and numerous other regional health plans. Notably, Blue Cross Blue Shield of Michigan (BCBSM), Florida Healthcare Plan, and several closed-door health systems have designated Yesintek as their exclusive ustekinumab product. BBL is also in the final stages of securing formulary agreements with additional commercial carriers, the company stated. Yesintek, a monoclonal antibody that inhibits IL-12 and IL-23 signaling associated with immune-mediated diseases, received U.S. FDA approval in December 2024. It is approved for the treatment of Crohns disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. Shreehas Tambe, CEO & managing director, Biocon Biologics, said: Yesintek (Ustekinumab kfce) represents an important milestone for Biocon Biologics, as this is the first product we have launched in the United States as a fully integrated biosimilars company. The strong adoption of Yesintek by payors in the U.S. reflects their confidence in our science, supply reliability, and commercial capability. Biocon Biologics, a subsidiary of Biocon, is a fully integrated, global biosimilars company. It has commercialized eight biosimilars in key emerging markets and advanced markets. It has a pipeline of 12 biosimilar assets under development across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases. Biocon is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. Biocon is a biopharmaceutical company manufacturing APIs, and generic formulations. It is also involved in research and development. The companys consolidated net profit declined 96.2% to Rs 25.10 crore in Q3 FY25 as compared with Rs 660 crore in Q3 FY24. Net sales increased 6.3% to Rs 3773 crore in Q3 FY25.
Yahoo
11-04-2025
- Business
- Yahoo
FDA approves Biocon Biologics' bevacizumab biosimilar for cancer
Biocon Biologics has gained approval from the US Food and Drug Administration (FDA) for the intravenous use of Jobevne (bevacizumab-nwgd), a biosimilar to the reference Avastin (bevacizumab). Jobevne is a recombinant humanised monoclonal antibody which functions as a vascular endothelial growth factor inhibitor, targeting the cancer and restricting the supply of blood to tumours. The approval bolsters the company's biosimilar oncology portfolio in the US, which includes Fulphila (Pegfilgrastim-jmdb) and Ogivri (Trastuzumab-dkst). The company has been marketing bevacizumab under the name Abevmy in Europe, where it was approved in February 2021. It also gained approval in November of the same year in Canada. The FDA approval was supported by a comprehensive package comprising comparative pharmacokinetic, efficacy, nonclinical, functional, safety, analytical and structural data that demonstrated Jobevne's high similarity to the reference product. In safety, efficacy, immunogenicity and pharmacokinetics, the data showed no clinically meaningful differences between Jobevne and Avastin. Biocon Biologics CEO and managing director Shreehas Tambe stated: 'The US FDA approval of Jobevne (bevacizumab-nwgd) is a significant milestone — our seventh biosimilar approved in the US and a strong addition to our robust oncology portfolio. 'It underscores the depth of our scientific expertise and commitment to expanding access to high-quality, affordable biologics. We look forward to working with all stakeholders to bring more treatment options to patients.' Biocon Biologics has commercialised nine biosimilars from a pipeline of 20 products in the US, Australia, Canada, Japan and Europe. Its development pipeline of biosimilar assets spans oncology, ophthalmology, immunology, diabetology and other non-communicable conditions. In August 2024, the company reached a settlement and licence agreement with Janssen Biotech, Janssen Sciences Ireland and Johnson & Johnson (together called Janssen) for the commercialisation of Bmab 1200 (bUstekinumab), a proposed biosimilar to Stelara. "FDA approves Biocon Biologics' bevacizumab biosimilar for cancer" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Associated Press
10-04-2025
- Business
- Associated Press
Biocon Biologics Announces U.S. FDA Approval for Jobevne™, Biosimilar Bevacizumab, Expanding Its Oncology Portfolio
BRIDGEWATER, N.J. and BENGALURU, India, April 10, 2025 /PRNewswire/ -- Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced that the U.S. Food and Drug Administration (U.S. FDA) has approved Jobevne™ (bevacizumab-nwgd), a biosimilar Bevacizumab for intravenous use. JOBEVNE, a recombinant humanized monoclonal antibody used to treat several different types of cancer, is a biosimilar to the reference product Avastin® (bevacizumab). JOBEVNE is a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis – combating cancer by restricting blood supply to the tumor. The approval of JOBEVNE expands Biocon Biologics' biosimilar oncology portfolio in the United States, which also includes OGIVRI (Trastuzumab-dkst) and FULPHILA (Pegfilgrastim-jmdb). The Company also markets Bevacizumab in Europe (approved February 2021) and Canada (approved November 2021) under the name ABEVMY. Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd., said: 'The U.S. FDA approval of JOBEVNE™ (bevacizumab-nwgd) is a significant milestone—our seventh biosimilar approved in the U.S. and a strong addition to our robust oncology portfolio. It underscores the depth of our scientific expertise and commitment to expanding access to high-quality, affordable biologics. We look forward to working with all stakeholders to bring more treatment options to patients.' In the U.S., sales of bevacizumab were approximately $2.0 billion in 2023.** Biocon Biologics is a leading global player in biosimilars and insulin production and has achieved many 'firsts' in the industry including the first to receive approval of a trastuzumab in the United States, OGIVRI (Trastuzumab-dkst), as well as FULPHILA (Pegfilgrastim-jmdb) and the first U.S. approval of an interchangeable biosimilar for SEMGLEE (insulin glargine). Serving over 5 million patients annually, Biocon Biologics has a comprehensive portfolio of in-market and in-development biosimilar products across multiple therapies, including seven approved biosimilars in the United States and six in Canada, with a robust development pipeline of 20 biosimilar assets, including insulins and monoclonal antibodies spanning multiple therapy areas. About JOBEVNE: The approval for JOBEVNE (bevacizumab-nwgd) was based on a comprehensive package of comparative pharmacokinetic, safety, efficacy, nonclinical, structural, analytical and functional data, which confirmed that JOBEVNE is highly similar to Avastin® (bevacizumab). The data demonstrated that there were no clinically meaningful differences between JOBEVNE and Avastin® in terms of pharmacokinetics, safety, efficacy, and immunogenicity. INDICATIONS AND USAGE: JOBEVNE is a vascular endothelial growth factor inhibitor indicated for the treatment of: Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first-or second-line treatment.* Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan-or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.* Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment. Recurrent glioblastoma in adults. Metastatic renal cell carcinoma in combination with interferon alfa. Persistent, recurrent, or metastatic advanced cervical cancer, in combination with paclitaxel and cisplatin, or paclitaxel and topotecan. Epithelial ovarian, fallopian tube, or primary peritoneal cancer: in combination with carboplatin and paclitaxel, followed by JOBEVNE as a single agent, for stage III or IV disease following initial surgical resection in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by JOBEVNE as a single agent, for platinum-sensitive recurrent disease * Limitations of Use: JOBEVNE is not indicated for adjuvant treatment of colon cancer. WARNINGS AND PRECAUTIONS: Gastrointestinal Perforations and Fistula: Discontinue for gastrointestinal perforations, tracheoesophageal fistula, Grade 4 fistula, or fistula formation involving any organ Surgery and Wound Healing Complications: In patients who experience wound healing complications during JOBEVNE treatment, withhold JOBEVNE until adequate wound healing. Withhold for at least 28 days prior to elective surgery. Do not administer JOBEVNE for at least 28 days following a major surgery, and until adequate wound healing. The safety of resumption of bevacizumab products after resolution of wound healing complication has not been established. Discontinue for wound healing complications of necrotizing fasciitis. Hemorrhage: Severe or fatal hemorrhages have occurred. Do not administer for recent hemoptysis. Discontinue for Grade 3-4 hemorrhage. Arterial Thromboembolic Events (ATE): Discontinue for severe ATE. Venous Thromboembolic Events (VTE): Discontinue for Grade 4 VTE. Hypertension: Monitor blood pressure and treat hypertension. Withhold until medically controlled; resume once controlled. Discontinue for hypertensive crisis or hypertensive encephalopathy. Posterior Reversible Encephalopathy Syndrome (PRES): Discontinue. Renal Injury and Proteinuria: Monitor urine protein. Discontinue for nephrotic syndrome. Withhold until less than 2 grams of protein in urine. Infusion-Related Reactions: Decrease rate for infusion-related reactions. Discontinue for severe infusion-related reactions and administer medical therapy. Embryo-Fetal Toxicity: May cause fetal harm. Advise females of potential risk to fetus and need for use of effective contraception. Ovarian Failure: Advise females of the potential risk. Congestive Heart Failure (CHF): Discontinue JOBEVNE in patients who develop CHF. Please refer to full Prescribing Information for Jobevne™ (bevacizumab-nwgd) for more information. To report SUSPECTED ADVERSE REACTIONS, contact Biocon Biologics at 1-833-986-1468 or FDA at 1-800-FDA-1088 or JOBEVNE is a trademark of Biosimilars Newco Limited, a Biocon Biologics Company. OGIVRI, FULPHILA, SEMGLEE and ABEVMY are registered trademarks of Biosimilars Newco Limited, a Biocon Biologics Company. BIOCON BIOLOGICS and the Biocon Biologics Logo are registered trademarks of Biocon Biologics Limited. All other trademarks are the property of their respective owners. **Sales projections are based on Biocon Biologics' analysis of IQVIA 2023 data. About Biocon Biologics Limited: Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Limited, is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives. It is capitalizing on its 'lab to market' capabilities to serve millions of patients across 120+ countries by enabling affordable access to high quality biosimilars. The Company is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world-class quality systems to lower costs of biological therapeutics while improving healthcare outcomes. Biocon Biologics has commercialized nine biosimilars from its pipeline of 20 products in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. It's pipeline has several biosimilar assets under development across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases. The Company has many 'firsts' to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, it is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). Website Follow us on X (formerly Twitter): @BioconBiologics and LinkedIn: Biocon Biologics for company updates. Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development. Website: Follow-us on X (formerly Twitter) @bioconlimited and LinkedIn: Biocon for company updates. Forward-Looking Statements: Biocon This press release may include statements of future expectations and other forward-looking statements based on management's current expectations and beliefs concerning future developments and their potential effects upon Biocon and its subsidiaries/ associates. These forward-looking statements involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from our expectations include, amongst other: general economic and business conditions in India and overseas, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currency changes, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition in and the conditions of the Indian and global biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. Neither Biocon, nor our Directors, or any of our subsidiaries/associates assume any obligation to update any particular forward-looking statement contained in this release.
