Intas Pharmaceuticals and Accord BioPharma expand global pegfilgrastim footprint with UDENYCA acquisition

Intas Pharmaceuticals and Accord BioPharma, the US specialty business of Intas, have completed the acquisition of UDENYCA (pegfilgrastim-cbqv) from Coherus BioSciences, Inc., strengthening their position as one of the largest global suppliers of pegfilgrastim.

The acquisition expands Intas and Accord’s US FDA-approved biosimilar portfolio. UDENYCA, a biosimilar to Neulasta (pegfilgrastim), is used to reduce the incidence of infection in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs and to increase survival in those exposed to myelosuppressive radiation doses.

In Europe, Accord has maintained market leadership in pegfilgrastim biosimilars, having been the first to commercialise a biosimilar pegfilgrastim and the only company to launch an autoinjector. The addition of UDENYCA supports Accord BioPharma’s strategy to expand its biosimilar footprint across the US and other international markets.

As part of the transaction, Accord BioPharma continues the commercialisation of UDENYCA in the US. The product is available in three formulations: autoinjector (AI), on-body injector (OBI), and prefilled syringe (PFS). According to company data, over 300,000 patients have been treated with UDENYCA and more than 1.4 million units have been distributed since launch.

Coherus employees from Sales, Marketing, Finance, Supply Chain, and Quality and Manufacturing have joined Accord BioPharma to support continuity and expansion of UDENYCA operations.

Binish Chudgar, Chairman and Managing Director of Intas Pharmaceuticals, said:
“We are energised by this addition to Accord BioPharma’s portfolio because it exemplifies our commitment to improving patient access to high-quality treatments that meet the evolving needs of both patients and healthcare providers. This acquisition cements our position as a global leader in pegfilgrastim and allows us to further expand our specialty division across key international markets.”

Chrys Kokino, US President of Accord BioPharma, commented:
“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.”

Paul Tredwell, EMENA Executive Vice-President of Accord, added:
“With the Accord Biopharma team now fully commercialising UDENYCA in three different formulations, this development strengthens Accord’s offering and advances our goal of becoming the world’s leading supplier of pegfilgrastim.”

INDICATIONS
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.

• 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 mobilisation of peripheral blood progenitor cells for haematopoietic stem cell transplantation.

IMPORTANT SAFETY INFORMATION

Contraindication:
UDENYCA is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim or filgrastim products. Reactions have included anaphylaxis.

Warnings and Precautions include:

• Fatal splenic rupture

• Acute respiratory distress syndrome (ARDS)

• Serious allergic reactions, including anaphylaxis

• Allergies to acrylics (UDENYCA ONBODY only)

• Sickle cell crises

• Glomerulonephritis

• Leukocytosis

• Thrombocytopenia

• Capillary leak syndrome

• Potential tumour growth stimulatory effects

• Myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML) in patients with breast and lung cancer

• Potential device failures (UDENYCA ONBODY)

• Aortitis

• Nuclear imaging interference

Adverse reactions:
Most common reactions (≥ 5 per cent higher incidence vs placebo) are bone pain and pain in extremity.

To report suspected adverse reactions:
Call 1-800-4-UDENYCA (1-800-483-3692) or report to FDA via www.fda.gov/medwatch.

Product formats:

• UDENYCA Prefilled Syringe: 6 mg/0.6 mL single-dose

• UDENYCA Autoinjector: 6 mg/0.6 mL single-dose

• UDENYCA ONBODY: 6 mg/0.6 mL co-packaged with the on-body injector

Advisory note:
Smith, Anderson, Blount, Dorsett, Mitchell & Jernigan, L.L.P. served as legal counsel to Accord and Intas for the transaction.