Latest news with #AccordBioPharma
Economic Times
3 days ago
- Business
- Economic Times
Intas Pharma completes acquisition of UDENYCA biosimilar for $558 million
Synopsis Intas Pharma finalized its acquisition of UDENYCA, a biosimilar to Neulasta, from Coherus Life Sciences for $558 million in December 2024. This acquisition strengthens Intas's position as a global leader in pegfilgrastim. Accord BioPharma, Intas's U.S. specialty business, will continue commercializing UDENYCA to reduce infection risk in cancer patients undergoing myelosuppressive chemotherapy. Agencies Intas Pharma has completed the acquisition of UDENYCA for $558 million, the company said in a release. UDENYCA is a biosimilar to Neulasta or Pegfilgrastim. It is used to treat side effects of radiation therapy in cancer patients such as recurrent infections. Intas acquired the biosimilar drug from California-based Coherus Life Sciences in December 2024.'This acquisition cements our position as a global leader in pegfilgrastim and allows us to further expand our specialty division across key international markets,' said Binesh Chudgar, Intas Pharma's chairman and managing Pharmaceuticals in collaboration with its global subsidiaries operating under the Accord brand, have acquired UDENYCA. With the acquisition, Accord BioPharma, the U.S. specialty business of Intas, continues the commercialization of UDENYCA to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia, the company's release stated.'The completion of the UDENYCA acquisition marks a pivotal moment for Accord BioPharma, as it not only strengthens our market presence but broadens our capabilities as we endeavour to innovate and expand in the biosimilar space,' said Chrys Kokino, President, USA, Accord BioPharma.
Time of India
3 days ago
- Business
- Time of India
Intas Pharma completes acquisition of UDENYCA biosimilar for $558 million
Intas Pharma has completed the acquisition of UDENYCA for $558 million, the company said in a release. UDENYCA is a biosimilar to Neulasta or Pegfilgrastim . It is used to treat side effects of radiation therapy in cancer patients such as recurrent infections. Finance Value and Valuation Masterclass - Batch 4 By CA Himanshu Jain View Program Artificial Intelligence AI For Business Professionals Batch 2 By Ansh Mehra View Program Finance Value and Valuation Masterclass - Batch 3 By CA Himanshu Jain View Program Artificial Intelligence AI For Business Professionals By Vaibhav Sisinity View Program Finance Value and Valuation Masterclass - Batch 2 By CA Himanshu Jain View Program Finance Value and Valuation Masterclass Batch-1 By CA Himanshu Jain View Program Intas acquired the biosimilar drug from California-based Coherus Life Sciences in December 2024. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Top 15 Most Beautiful Women in the World Undo 'This acquisition cements our position as a global leader in pegfilgrastim and allows us to further expand our specialty division across key international markets,' said Binesh Chudgar, Intas Pharma's chairman and managing director. Intas Pharmaceuticals in collaboration with its global subsidiaries operating under the Accord brand, have acquired UDENYCA. Live Events With the acquisition, Accord BioPharma , the U.S. specialty business of Intas, continues the commercialization of UDENYCA to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia, the company's release stated. 'The completion of the UDENYCA acquisition marks a pivotal moment for Accord BioPharma, as it not only strengthens our market presence but broadens our capabilities as we endeavour to innovate and expand in the biosimilar space,' said Chrys Kokino, President, USA, Accord BioPharma.
Business Standard
07-08-2025
- Business
- Business Standard
Intas Pharmaceuticals and Accord BioPharma Become One of the Largest Global Suppliers of Pegfilgrastim with Acquisition of UDENYCA®
PRNewswire Ahmedabad (Gujarat) [India], August 7: Intas Pharmaceuticals in collaboration with its global subsidiaries operating under the Accord brand, has solidified its position as one of the world's leading suppliers of pegfilgrastim following the successful acquisition of UDENYCA® (pegfilgrastim-cbqv) from Coherus BioSciences, Inc. UDENYCA®, a biosimilar to Neulasta® (pegfilgrastim), significantly expands Intas and Accord's FDA-approved biosimilar portfolio and accelerates their strategic growth in the global biosimilar market. Accord is already a pegfilgrastim market leader in Europe--having been the first to commercialize a biosimilar pegfilgrastim and the only company to launch an autoinjector-- has maintained its leadership despite intense competition. This acquisition further strengthens the company's presence and impact in both the U.S. and international biosimilar landscapes. With the acquisition, Accord BioPharma, the U.S. specialty business of Intas, continues the commercialization of UDENYCA® to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. UDENYCA® offers three patient-friendly administration options--autoinjector (AI), on-body injector (OBI), and prefilled syringe (PFS)--providing flexibility for treatment at home, on-the-go, or in clinical settings. Since its commercial launch, over 300,000 patients have been treated with UDENYCA® and more than 1.4 million units have been distributed. The acquisition not only expands Accord BioPharma's product offerings but also brings a wealth of talent from Coherus BioSciences. Key Coherus employees across multiple functions, including Sales, Marketing, Finance, Supply Chain, and Quality and Manufacturing, who have joined Accord BioPharma, will play a crucial role in supply and services continuity/transition and expanding the company's work around UDENYCA®. Paul Tredwell, EMENA Executive Vice-President of Accord, added: "With the Accord Biopharma team now fully commercializing UDENYCA® in three different formulations, this development strengthens Accord's offering and advances our goal of becoming the world's leading supplier of pegfilgrastim." UDENYCA® (pegfilgrastim-cbqv) INDICATION UDENYCA® is a leukocyte growth factor indicated to: * Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. * Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). Limitations of Use UDENYCA® is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. IMPORTANT SAFETY INFORMATION CONTRAINDICATION: Patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis. WARNINGS AND PRECAUTIONS: - Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture. - Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue UDENYCA® in patients with ARDS. - Serious allergic reactions, including anaphylaxis: The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue UDENYCA® in patients with serious allergic reactions. - Allergies to Acrylics (UDENYCA ONBODY® only): The on-body injector (OBI) for UDENYCA® uses acrylic adhesive. For patients who have reactions to acrylic adhesives, use of this product may result in a significant reaction. - Sickle cell crises: Severe and sometimes fatal crises have occurred. Discontinue UDENYCA® if sickle cell crisis occurs. - Glomerulonephritis: The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events resolved after dose reduction or discontinuation. Evaluate and consider dose-reduction or interruption of UDENYCA® if causality is likely. - Leukocytosis: White blood cell (WBC) counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of complete blood count (CBC) during UDENYCA® therapy is recommended. - Thrombocytopenia: Thrombocytopenia has been reported in patients receiving pegfilgrastim. Monitor platelet counts. - Capillary Leak Syndrome: Has been reported after G-CSF administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. If symptoms develop, closely monitor and give standard symptomatic treatment, which may include a need for intensive care. - Potential for Tumor Growth Stimulatory Effects on Malignant Cells: The granulocyte colony stimulating factor (G-CSF) receptor through which pegfilgrastim products and filgrastim products act has been found on tumor cell lines. The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded. - Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer: MDS and AML have been associated with the use of pegfilgrastim in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings. - Potential Device failures ( UDENYCA ONBODY® only): Missed or partial doses have been reported for products administered via on-body injectors due to the device not performing as intended. In the event of a missed or partial dose, patients may be at increased risk of events such as neutropenia, febrile neutropenia and/or infection than if the dose had been correctly delivered. Instruct patients using the OBI to notify their healthcare professional immediately to determine the need for a replacement dose of UDENYCA® if they suspect that the device may not have performed as intended. - Aortitis: Has been reported in patients receiving pegfilgrastim products, occurring as early as the first week after start of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count). Consider aortitis when signs and symptoms develop without known etiology. Discontinue UDENYCA® if aortitis is suspected. - Nuclear Imaging: Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. Consider when interpreting bone imaging results. ADVERSE REACTIONS: Most common adverse reactions (>= 5% difference in incidence compared to placebo) are bone pain and pain in extremity. To report SUSPECTED ADVERSE REACTIONS, contact 1-800-4-UDENYCA (1-800-483-3692) or notify the FDA at 1-800-FDA-1088 or UDENYCA® Prefilled Syringe: 6 mg/0.6 mL in a single-dose prefilled syringe for manual use only. UDENYCA® Autoinjector: 6 mg/0.6 mL in a single-dose prefilled autoinjector. UDENYCA ONBODY®: 6 mg/0.6 mL in a single-dose prefilled syringe co-packaged with the on-body injector for UDENYCA®. Advisors Smith, Anderson, Blount, Dorsett, Mitchell & Jernigan, L.L.P. acted as legal counsel to Accord and Intas with respect to the Transaction. About Intas Pharmaceuticals Intas Pharmaceuticals is a pioneer in biosimilars, having developed and launched one of the highest numbers of indigenous biosimilars in India. Intas Pharmaceuticals has a rich history of making quality biosimilars accessible to the masses in India. Intas' products like Neukine (filgrastim), Pegasta (Pegfilgrastim), Mabtas (rituximab), Razumab (ranibizumab) and Bevatas (bevacizumab) have transformed the management of their respective therapies in India. Eleftha is the latest testament to Intas' Biosimilar for Billions philosophy, fulfilling its commitment to provide quality care to the masses in India. Intas' biosimilars are manufactured at Intas Pharmaceuticals' European Union- Good Manufacturing Practices (EU-GMP) certified biotechnology plant located near Ahmedabad, Gujarat. For more information, visit About Accord BioPharma Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, seeks to provide affordable, accessible, patient-centric therapies in oncology, immunology, and critical care. With a focus on improving the patient experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patients' perspective and develop high-quality therapies that impact patients' lives. Accord BioPharma believes in the ability of biosimilars to increase access to a number of biologic medicines, that in the past may not have been considered for patients due to their high costs. Accord BioPharma looks forward to providing one of the deepest biosimilar portfolios in the industry. For more information, visit About Coherus BioSciences Coherus BioSciences, Inc. is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer. Coherus is developing an innovative immuno-oncology pipeline that is expected to be synergistic with its proven commercial capabilities in oncology. References: 1. UDENYCA® Prescribing Information. Coherus BioSciences; December 2023. All trademarks, logos and brand names are the property of their respective owners. Logo:
Yahoo
10-02-2025
- Business
- Yahoo
Bio-Thera Solutions Announces Exclusive Commercialization and License Agreement with Intas Pharmaceuticals for BAT2506, a Proposed Biosimilar Referencing Simponi® (golimumab), in the United States of America
GUANGZHOU, China, Feb. 10, 2025 /PRNewswire/ -- Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced the company has reached an exclusive commercialization and license agreement with Intas Pharmaceuticals for BAT2506, a golimumab biosimilar, for the United States of America. BAT2506 is a proposed golimumab biosimilar developed by Bio-Thera. Golimumab is a human IgG1 monoclonal antibody that targets tumor necrosis factor alpha (TNF-a), a pro-inflammatory molecule. Binding of golimumab to TNF-a results in reductions in C-reactive protein (CRP), Interleukin 6 (IL-6), Intercellular Adhesion Molecule 1 (ICAM-1), Matrix Metalloproteinase 3 (MMP-3), and Vascular Endothelial Growth Factor (VEGF), all inflammatory markers. The reference medicine golimumab has been approved in the United States and Europe for several indications, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. Under the agreement, Bio-Thera will maintain responsibility for development, manufacturing, and supply of BAT2506. Intas Pharmaceuticals, through its US-specialty division Accord BioPharma, will be responsible for commercializing the product in the United States of America. Bio-Thera will receive an upfront payment of $21 million USD, as well as further development and commercial milestones of up to $143.5 million USD. "Accord BioPharma is a leading biosimilar company in the United States, and we are pleased to establish this commercial partnership with Accord for BAT2506," said Dr. Shengfeng Li, CEO of Bio-Thera. "This partnership will expand Bio-Thera's efforts to bring more immunology biosimilars to patients in USA." "Our exclusive commercialization agreement with Bio-Thera strengthens our biosimilar pipeline, a vital component of our U.S. growth strategy," said Chrys Kokino, U.S. President of Accord. "We're investing heavily in biosimilars through external partnerships plus our own clinical efforts, because we believe in their vast potential to drive patient- and provider-centric solutions. Bio-Thera's global experience makes them an excellent partner." About Bio-Thera SolutionsBio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including four approved products: QLETLI® and BETAGRIN® (Bevifibatide Citrate Injection) in China, and TOFIDENCE™/ BAT1806 and Avzivi® / Pobevcy® in the US, EU and China. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as ADCs. For more information, please visit or follow us on Twitter (@bio_thera_sol) and WeChat (Bio-Thera). About Intas PharmaceuticalsIntas Pharmaceuticals is a pioneer in biosimilars, having developed and launched one of the highest numbers of indigenous biosimilars in India. Intas Pharmaceuticals has a rich history of making quality biosimilars accessible to the masses. Being the most affordable treatment option, Intas' products like Neukine (filgrastim), Pegasta (Pegfilgrastim), Mabtas (rituximab), Razumab (ranibizumab) and Bevatas (bevacizumab) have transformed the management of their respective therapies. Eleftha is the latest testament to Intas' Biosimilar for Billions philosophy, fulfilling its commitment to provide quality cancer care to the masses. Intas' biosimilars are manufactured at Intas Pharmaceuticals' state of the art European Union- Good Manufacturing Practices (EU-GMP) certified biotechnology plant located near Ahmedabad, Gujarat. For more information, visit us at About Accord BioPharma, BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, seeks to provide affordable, accessible, patient-centric therapies in oncology, immunology, and critical care. With a focus on improving the patient experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patients' perspective and develop high-quality therapies that impact patients' lives. Accord BioPharma believes in the ability of biosimilars to increase access to a number of biologic medicines, that in the past may not have been considered for patients due to their high costs. Accord BioPharma looks forward to providing one of the deepest biosimilar portfolios in the industry. For more information, visit Bio-Thera Cautionary Note Regarding Forward-Looking StatementsThis news release contains certain forward-looking statements relating to BAT2506, or the product pipelines in general of Bio-Thera Solutions. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing "could," "may," "should," "will," "would," "anticipate," "believe," "plan," "promising," "potentially," or similar expressions. They reflect the company's current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information currently available to Bio-Thera Solutions, and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research and development, such as the uncertainties of pre-clinical and clinical studies. Other risks and uncertainties include challenges in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, changes in the company's financial conditions, and changes to applicable laws and regulations, etc. Forward-looking statements contained herein are made only as of the date of their initial publication. Unless required by laws or regulations, Bio-Thera Solutions undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in the company's views or otherwise. 1. Simponi® is a registered trademark of Johnson & Johnson2. QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd.3. TOFIDENCE™ is a trademark of Biogen MA Inc.4. Avzivi® is a registered trademark of Sandoz AG5. POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd.6. BETAGRIN® is a registered trademark of Bio-Thera Solutions, Ltd. ContactBert E. Thomas IVPhone: +1.410.627.1734Email: bethomas@ View original content to download multimedia: SOURCE Bio-Thera Solutions, Ltd Sign in to access your portfolio
