EMA recommends approval of teriparatide and pegfilgrastim biosimilars

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EMA recommends approval of teriparatide and pegfilgrastim biosimilars

Biosimilares/Novedades | Posted 18/02/2022 0 Post your comment

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 28 January 2022 that it had recommended granting of marketing authorization for the teriparatide biosimilar Sondelbay and the pegfilgrastim biosimilar Stimufend.

Sondelbay is produced by India-based generics maker Accord Healthcare (a subsidiary of Intas Pharmaceuticals). The drug is a biosimilar of Eli Lilly’s Forteo/Forsteo (teriparatide), a recombinant form of parathyroid hormone (PTH). Teriparatide is an effective anabolic, i.e. bone growing agent. It is therefore used for the treatment of osteoporosis in postmenopausal women and men at high risk for fracture and for glucocorticoid-induced osteoporosis in men and postmenopausal women.

The positive opinion from the EMA’s CHMP recommends that Sondelbay be used for the treatment of osteoporosis. This comes as a relief to Accord Healthcare, which had to withdraw its original application back in June 2020 [1] after EMA raised concerns over the way the main study had been carried out and that the distribution of the medicine in the body had not been fully established.

Stimufend is produced by Fresenius Kabi, the generics unit of German healthcare giant Fresenius. The drug is a biosimilar of Amgen’s Neulasta (pegfilgrastim), a PEGylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue filgrastim. Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy.

The positive opinion from the EMA’s CHMP recommends that Stimufend be used to reduce the duration of neutropenia and the incidence of febrile neutropenia after cytotoxic chemotherapy.

The CHMP positive opinions will now be considered by the European Commission (EC). Once approved the EC will grant a centralized marketing authorization for Member States of the European Union.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Feb 18]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe

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Source: EMA