Ahmedabad: In a strategic move to expand their global biosimilar footprint, Intas Pharmaceuticals and its U.S. specialty subsidiary Accord BioPharma have completed the acquisition of UDENYCA (pegfilgrastim-cbqv) from Coherus BioSciences, Inc., emerging as one of the world’s largest suppliers of pegfilgrastim.
UDENYCA, a biosimilar to Amgen’s Neulasta, is indicated to reduce the risk of infection due to febrile neutropenia in patients with non-myeloid malignancies undergoing myelosuppressive chemotherapy. It also plays a critical role in increasing survival in patients exposed to high-dose radiation.
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With this acquisition, Accord BioPharma now offers UDENYCA in three convenient formulations – autoinjector (AI), on-body injector (OBI), and prefilled syringe (PFS) – enabling greater flexibility for patient-centric care in both clinical and at-home settings. Since its commercial introduction, UDENYCA has treated over 300,000 patients, with more than 1.4 million units distributed.
Strengthening Global Biosimilar Presence
Accord has already demonstrated leadership in Europe by being the first to commercialize a pegfilgrastim biosimilar and launch an autoinjector version – a distinction it retains even amidst heightened competition. The UDENYCA acquisition propels Accord’s strategic position in the U.S. biosimilar market and expands Intas’s specialty care portfolio globally.
Workforce and Operational Continuity
As part of the transaction, key employees from Coherus BioSciences across Sales, Marketing, Finance, Supply Chain, and Manufacturing have joined Accord BioPharma. This seamless transition ensures uninterrupted supply chain operations and enhances capabilities around UDENYCA commercialization.
“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 endeavor to innovate and expand in the biosimilar space,” said Chrys Kokino, U.S. President, Accord BioPharma.
“This development strengthens our pegfilgrastim offering and advances our goal of becoming the world’s leading biosimilar supplier,” added Paul Tredwell, EMENA EVP, Accord.
Binish Chudgar, Chairman and MD, Intas Pharmaceuticals, noted: “This acquisition aligns with our mission to expand global access to high-quality therapies that meet evolving patient and provider needs. It reinforces our leadership in pegfilgrastim and supports our specialty division’s growth across key markets.”
About UDENYCA (pegfilgrastim-cbqv)
UDENYCA is a leukocyte growth factor approved for:
- Reducing the incidence of febrile neutropenia in cancer patients undergoing myelosuppressive chemotherapy.
- Increasing survival in patients exposed to myelosuppressive radiation.
- Not indicated for stem cell mobilization.
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Important Safety Information
UDENYCA is contraindicated in patients with known allergic reactions to pegfilgrastim or filgrastim. Serious risks include:
- Fatal splenic rupture
- Acute respiratory distress syndrome (ARDS)
- Anaphylaxis and allergic reactions
- Glomerulonephritis, sickle cell crises
- Myelodysplastic syndrome (MDS) and AML in certain cancer types
- Aortitis, thrombocytopenia, leukocytosis, and capillary leak syndrome
- On-body injector device failures
- Common side effects include bone pain and pain in extremities.
For detailed safety guidance or to report adverse reactions, contact 1-800-4-UDENYCA or visit www.fda.gov/medwatch.
Legal counsel for the transaction was provided by Smith, Anderson, Blount, Dorsett, Mitchell & Jernigan, LLP
