On 25 June 2026, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions, recommending the granting of marketing authorizations (MA) for two biosimilar medicines: Ascend’s Denosumab Ascend and Qilu’s pegfilgrastim Nylaspeg.
The CHMP's June 2026 meeting recommended six new medicines for approval overall, including these two biosimilars, alongside positive opinions for Hopledo (levodopa/carbidopa) for Parkinson's disease and Onswik (insulin efsitora alfa) for type 2 diabetes.
Denosumab Ascend
Denosumab Ascend a proposed biosimilar to the reference product Xgeva (Amgen), which was authorised in the EU on 13 July 2011. It is designed as a 120 mg solution for injection. The applicant for this medical product is Ascend GmbH.
Denosumab Ascend is indicated for the prevention of skeletal-related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone, and for the treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Ascend GmbH is a subsidiary of Alkem Laboratories. In May 2025, Ascend withdrew its biosimilar marketing authorisation application for Teriparatide Ascend [1]. The company and its parent Alkem are currently parties to BPCIA litigation commenced by Amgen in November 2025 following the filing of Alkem/Ascend's biologics licence application for biosimilar denosumab in the US.
Nylaspeg (pegfilgrastim)
Nylaspeg is a biosimilar drug developed by Qilu Pharmaceuticals (Qilu), referencing Amgen's Neulasta (pegfilgrastim), which was authorized in the EU on 22 August 2002.
The recommendation comes over seven years after the approval of the first European pegfilgrastim biosimilar, Accord Healthcare’s Pelgraz®, in September 2018.
Nylaspeg will be available as a 6 mg solution for injection in pre-filled syringes.
It is intended to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Qilu has its first biosimilar—ranibizumab Rimmyrah—approved in the EU on 5 January 2024 [2].
European landscape for denosumab and pegfilgrastim biosimilars
2026 marks the 20-year anniversary of the EU biosimilar regulatory framework. Over the years, EMA's scientific experts have reviewed 180 biosimilars and issued positive opinions for 160 of these, demonstrating the EU's position as a global leader in biosimilar regulation [3].
Currently, there are 14 Denosumab biosimilars referencing Xgeva approved in Europe since the first approval in May 2024 (Sandoz’s Wyost) [4].
Since the first approval of pegfilgrastim biosimilar in September 2018, there are altogether 11 pegfilgastim biosimilars approved including Nylaspeg.
There were no biosimilars approved by the EMA in January and March 2026.
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References
1. GaBI Online - Generics and Biosimilars Initiative. EC approves three biosimilars, 14 more await final authorization [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jul 21]. Available from: www.gabionline.net/biosimilars/news/ec-approves-three-biosimilars-14-more-await-final-authorization
2. GaBI Online - Generics and Biosimilars Initiative. EC approval of ranibizumab biosimilar Rimmyrah [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jul 21]. Available from: www.gabionline.net/biosimilars/news/ec-approval-of-ranibizumab-biosimilar-rimmyrah
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jul 21]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
4. GaBI Online - Generics and Biosimilars Initiative. EC biosimilar approvals: Omlyclo, Jubbonti/Wyost, and Pyzchiva [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jul 21]. Available from: www.gabionline.net/biosimilars/news/ec-biosimilar-approvals-omlyclo-jubbonti-wyost-and-pyzchiva
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