Two established hematology-oncology treatments, a generic ruxolitinib and a pegfilgrastim biosimilar, moved closer to EU approval after the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued positive opinions for both at its July meeting.

The recommendations would clear the way for marketing authorizations for Ruxolitinib Viatris (ruxolitinib, Viatris Limited), a generic version of Jakavi for myelofibrosis, polycythemia vera, and graft-vs-host disease (GVHD), and for Cavoley (pegfilgrastim, CuraTeQ Biologics), a biosimilar of Neulasta used to reduce the duration of neutropenia and the risk for febrile neutropenia after cytotoxic chemotherapy.

Generic Ruxolitinib 

Ruxolitinib Viatris, manufactured by Viatris Limited, is a generic formulation of ruxolitinib. It is indicated for:

• Myelofibrosis: treatment of disease-related splenomegaly or symptoms in adults with primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis 
• Polycythemia vera: treatment of adults with polycythemia vera who are resistant to or intolerant of hydroxyurea 
• Acute GVHD: treatment of adults and pediatric patients aged 28 days or older with acute GVHD after inadequate response to corticosteroids or other systemic therapies 
• Chronic GVHD: treatment of adults and pediatric patients aged 6 months or older with chronic GVHD after inadequate response to corticosteroids or other systemic therapies 

The medicine is a protein kinase inhibitor that selectively inhibits Janus-associated kinases involved in cytokine and growth factor signaling pathways linked to hematopoiesis and immune function. The product was considered bioequivalent to Jakavi, the reference medicine authorized in the EU since August 2012.

The medicine will be available as 5-, 10-, 15-, and 20-mg tablets. It should be prescribed by physicians experienced in administering anticancer therapies.

Biosimilar for Neutropenia Prevention 

Cavoley is a biosimilar of Neulasta (pegfilgrastim) for reducing the duration of neutropenia and the incidence of febrile neutropenia in adults receiving cytotoxic chemotherapy for cancer, excluding patients with chronic myeloid leukemia and myelodysplastic syndromes.

Pegfilgrastim is an immunostimulant and colony-stimulating factor that promotes the development and differentiation of mature, functionally active neutrophils from precursor cells in the bone marrow.

Cavoley is highly similar to Neulasta, which has been authorized in the EU since August 2002, with comparable quality, safety, and efficacy. It will be available as a 6-mg solution for injection in prefilled syringes and should be initiated and supervised by physicians experienced in oncology or hematology.

Regulatory Next Steps 

The European Commission must approve both medicines before they become available to patients. Final marketing authorization decisions are typically issued within 67 days of CHMP opinion adoption.

Following approval, detailed prescribing information, including guidance on patient selection, dosing, and safety monitoring, will be published in the medicines’ Summary of Product Characteristics in all official EU languages.