Intas Pharmaceuticals, in collaboration with its global Accord brand subsidiaries, has completed the acquisition of UDENYCA (pegfilgrastim-cbqv) from Coherus BioSciences, Inc., positioning the companies as one of the largest global suppliers of pegfilgrastim. The biosimilar to Amgen's Neulasta significantly expands Intas and Accord's FDA-approved biosimilar portfolio and strategic growth plans in the global biosimilar market.
Strategic Market Positioning
Accord BioPharma, the U.S. specialty business of Intas, continues the commercialization of UDENYCA following the acquisition. The company brings unique market experience, having been the first to commercialize a pegfilgrastim biosimilar in Europe and the only company to launch an autoinjector formulation.
"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," commented Chrys Kokino, U.S. President of Accord BioPharma.
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."
Clinical Applications and Formulations
UDENYCA is 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. The drug is also indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation for Hematopoietic Subsyndrome of Acute Radiation Syndrome.
The biosimilar offers three patient-friendly administration options: autoinjector (AI), on-body injector (OBI), and prefilled syringe (PFS). Each formulation contains 6 mg/0.6 mL in a single-dose format, providing flexibility for different patient needs and preferences.
Safety Profile and Monitoring Requirements
UDENYCA carries several important safety considerations that require careful monitoring. The drug is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim or filgrastim products, including anaphylaxis. Healthcare providers must evaluate patients for potential splenic rupture if they report left upper abdominal or shoulder pain, and monitor for acute respiratory distress syndrome in patients who develop fever, lung infiltrates, or respiratory distress.
White blood cell counts of 100 x 10⁹/L or greater have been observed in patients receiving pegfilgrastim products, making complete blood count monitoring during therapy essential. The most common adverse reactions include bone pain and pain in extremity, occurring at rates ≥5% higher than placebo.
Organizational Integration
The acquisition brings talent from Coherus BioSciences employees across multiple functions, including Sales, Marketing, Finance, Supply Chain, and Quality and Manufacturing, who have joined Accord BioPharma. This integration strengthens the operational capabilities for UDENYCA commercialization.
Company Background
Intas Pharmaceuticals is a pioneer in biosimilars, having developed and launched one of the highest numbers of indigenous biosimilars in India. The company's biosimilar portfolio includes Neukine (filgrastim), Pegasta (pegfilgrastim), Mabtas (rituximab), Razumab (ranibizumab), and Bevatas (bevacizumab), all manufactured at EU-GMP certified biotechnology facilities.
Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, focuses on providing affordable, accessible, patient-centric therapies in oncology, immunology, and critical care, with an emphasis on developing one of the deepest biosimilar portfolios in the industry.
