In March 2025, the US Food and Drug Administration (FDA) approved three biosimilars: Omlyclo (omalizumab-igec), the first and only biosimilar designated as interchangeable with Xolair, as well as Bomyntra and Conexxence (denosumab-bnht), which reference Xgeva and Prolia (denosumab)
Bomyntra and Conexxence (denosumab-bnht)
On 25 March 2025, the FDA approved Fresenius Kabi’s Bomyntra and Conexxence (denosumab-bnht) as biosimilars referencing Amgen’s Xgeva and Prolia, respectively.
The approval was based on comprehensive analytical development and similarity assessment, supported by two clinical studies: a pharmacokinetic, pharmacodynamic, and immunogenicity study in healthy volunteers, and an efficacy, safety, and immunogenicity study in women with postmenopausal osteoporosis.
Bomyntra is approved to prevent skeletal-related events in adult patients with multiple myeloma and bone metastases from solid tumours. It also treats hypercalcemia of malignancy refractory to bisphosphonate therapy and giant cell tumour of bone in adults and skeletally mature adolescents.
Conexxence is approved for use in various adult patients at high risk for fractures, including those with osteoporosis, individuals undergoing certain cancer treatments that affect bone density, and patients receiving long-term glucocorticoid therapy.
Bomyntra is available as a 120 mg/1.7 mL (70 mg/mL) injection, while Conexxence is available as a 60 mg/mL injection.
There are already four other denosumab biosimilars approved in the US: Sandoz’s Jubbonti and Wyost (denosumab-bddz) [1], and Samsung Bioepis’ Ospomyv and Xbryk (denosumab-dssb) [2].
Two denosumab biosimilars, Accord’s Osvyrti and Jubereq, also received a positive opinion from theEuropean Medicines Agency’s Committee for Medicinal Products for Human Use in March 2025 [3].
Omlyclo (omalizumab-igec)
On 7 March 2025, the FDA approved Celltrion’s Omlyclo (omalizumab-igec)/CT-P39, the first and only biosimilar designated as interchangeable with Xolair (omalizumab),
Omlyclo is indicated for the treatment of moderate-to-severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), Immunoglobulin E (IgE)-mediated food allergy, and chronic spontaneous urticaria (CSU).
The approval and interchangeable designation were supported by comprehensive clinical data, including results from a global Phase III clinical trial involving 619 adult patients with CSU evaluated up to Week 40. Patients received either Omlyclo (150 mg or 300 mg) or the reference drug (Novartis’ Xolair) every 4 weeks. At Week 12, some patients switched to Omlyclo, while others continued the reference drug. Treatment was paused at Week 24, with follow-up through Week 40. The results demonstrated that Omlyclo had comparable efficacy and safety to the reference drug during and after treatment.
Omlyclo is available as 75mg/0.5 mL and 150 mg/mL solution for injection in pre-filled syringe.
The ‘interchangeable’ designation allows pharmacists to substitute Omlyclo for Xolair at the pharmacy level without prescriber intervention, similar to generics substitutions for brand-name drugs. However, substitution practices depend on state-specific pharmacy laws [4].
Additionally, Omlyclo is the first and only omalizumab biosimilar approved in Europe [5] and Canada [6].
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References
1. GaBI Online - Generics and Biosimilars Initiative. First denosumab biosimilars approved in Canada and the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Apr 7]. Available from: www.gabionline.net/biosimilars/news/first-denosumab-biosimilars-approved-in-canada-and-the-us
2. GaBI Online - Generics and Biosimilars Initiative. Insulin aspart and denosumab biosimilars approved in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Apr 7]. Available from: www.gabionline.net/biosimilars/news/insulin-aspart-and-denosumab-biosimilars-approved-in-us
3. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval for three biosimilars in March: Jubereq, Osvyrti, and Qoyvolma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Apr 7]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-for-three-biosimilars-jubereq-osvyrti-and-qoyvolma
4. GaBI Online - Generics and Biosimilars Initiative. 45 US states have passed biosimilar substitution laws [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Apr 7]. Available from: www.gabionline.net/policies-legislation/45-US-states-have-passed-biosimilar-substitution-laws
5. GaBI Online - Generics and Biosimilars Initiative. EC biosimilar approvals: Omlyclo, Jubbonti/Wyost, and Pyzchiva [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Apr 7]. Available from: www.gabionline.net/biosimilars/news/ec-biosimilar-approvals-omlyclo-jubbonti-wyost-and-pyzchiva
6. GaBI Online - Generics and Biosimilars Initiative. Canada approves first omalizumab biosimilar Omlyclo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Apr 7]. Available from: www.gabionline.net/biosimilars/news/canada-approves-first-omalizumab-biosimilar-omlyclo
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