#USA #Accord BioPharma #UDENYCA #Intas Pharmaceuticals #Ahmedabad

Intas Pharmaceuticals and Accord BioPharma

Intas Pharmaceuticals, alongside its global subsidiaries trading under the Accord brand, has successfully established itself as a dominant player in the global pegfilgrastim market following the acquisition of UDENYCA® (pegfilgrastim-cbqv) from Coherus BioSciences, Inc. This strategic move not only bolsters their existing product portfolio but also enhances their competitive positioning in the biosimilar market.

Growth and Expansion in Biosimilars

The acquisition marks a significant milestone for Intas and Accord, particularly in light of the increasing demand for effective treatments in the oncology sector. UDENYCA serves as a biosimilar to Neulasta® (pegfilgrastim), and its addition to the Accord portfolio aligns with the company's mission to provide cost-effective healthcare solutions.

Accord has solidified its reputation in Europe as a leading supplier of pegfilgrastim, having pioneered the commercialization of the first pegfilgrastim biosimilar and introduced the unique auto-injector for patient convenience. Despite facing rigorous competition, Accord’s market leadership remains steadfast.

The successful integration of UDENYCA into Accord BioPharma’s offerings is anticipated to significantly enhance patient care. UDENYCA is specifically indicated for reducing the risk of infections characterized by febrile neutropenia in patients undergoing malignancy treatments with myelosuppressive anticancer medications. UDENYCA provides patients with a range of administration options, including an auto-injector, on-body injector, and pre-filled syringe, thereby enhancing home treatment flexibility.

Meeting Market Needs

Since its commercial launch, UDENYCA has benefited over 300,000 patients, with over 1.4 million units distributed globally. This impressive reach underlines the urgent need for such biosimilars, particularly in an era where healthcare access and costs are under constant scrutiny.

Beyond enhancing its product line, the acquisition of UDENYCA brings forth invaluable expertise from Coherus BioSciences. The transition will see many key team members transferring to Accord, contributing their vast knowledge across sales, marketing, finance, supply chain, and manufacturing—essential areas that will facilitate a seamless transition in service and supply continuity for UDENYCA.

Chrys Kokino, President of Accord BioPharma in the U.S., expressed enthusiasm about this pivotal acquisition, stating, “This strengthens our market presence while boosting our capabilities in innovating and expanding in the biosimilar space.” Similarly, Paul Tredwell, Executive Vice President at Accord for EMENA, indicated, “Our move to fully commercialize UDENYCA in three formulations reinforces our goal of becoming the world’s leading pegfilgrastim supplier.”

The Vision for Future Growth

Binish Chudgar, Chairman and CEO of Intas Pharmaceuticals, is equally optimistic, suggesting that this new addition not only fulfills their promise to provide high-quality treatment access but also signifies their dedication to meeting the evolving needs of patients and healthcare professionals. With this acquisition, Intas further cements its position as a global leader in pegfilgrastim supply, setting the stage for growth in major international markets.

Indications and Important Usage Information

UDENYCA is indicated for reducing the incidence of infections manifested by febrile neutropenia in patients with non-myeloid malignancies undergoing myelosuppressive anticancer drugs known to significantly cause febrile neutropenia. It is also marked for increasing survival in patients following acute exposure to myelosuppressive doses of radiation.

Limitations of use: UDENYCA is not indicated for mobilizing peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Safety Information and Contraindications

Contraindications include patients with a history of serious allergic reactions to pegfilgrastim or filgrastim. Warnings and precautions advise monitoring for conditions like splenic rupture, acute respiratory distress syndrome (ARDS), serious allergic reactions, and other significant risks like leukocytosis or thrombocytopenia associated with treatment.

Conclusion

This acquisition of UDENYCA is not just a strategic business move but a commitment to improving patient outcomes across various therapeutic areas. As Intas Pharmaceuticals and Accord BioPharma forge ahead, their focus on innovation and patient-centric solutions is set to redefine healthcare access and efficacy.