In June 2024, the results of a phase III clinical trial of P043/Zerafil (omalizumab), a proposed biosimilar of Novartis’ Xolair produced by CinnaGen in Iran, showed no significant difference in efficacy and safety parameters to the originator.
Omalizumab is used to treat asthma, as well as nasal polyps and chronic idiopathic urticaria (itchy rash). Omalizumab is a recombinant DNA-derived humanized IgG1k monoclonal antibody that specifically binds to free human immunoglobulin E (IgE) in the blood and interstitial fluid and to membrane-bound form of IgE (mIgE) on the surface of mIgE-expressing B lymphocytes. Unlike an ordinary anti-IgE antibody, it does not bind to IgE that is already bound by the high affinity IgE receptor (FcεRI) on the surface of mast cells, basophils, and antigen-presenting dendritic cells [1].
The originator product, Novartis’ Xolair (omalizumab), is indicated for the treatment of moderate to severe persistent asthma and chronic idiopathic urticaria in patients who do not respond to antihistamine treatment.
CinnaGen, a leading biotechnology company in Iran, has developed P043/Zerafil, a proposed biosimilar of omalizumab, and has recently completed a comprehensive phase III clinical trial to evaluate its efficacy, safety, and immunogenicity compared to the originator product, Xolair.
The phase III trial (NCT05813470) enrolled 256 participants and assessed the primary outcome of the rate of protocol-defined asthma exacerbations [2]. Exacerbation rates, Asthma Control Test (ACT) results, spirometry measurements, immunogenicity, and safety were evaluated, and the results have been published [3]. The study results demonstrated the equivalence of P043/Zerafil and Xolair in terms of efficacy and safety [3].
A total of 288 adverse events were reported, with ‘dyspnoea’ and ‘headache’ being the most common. The overall incidence of adverse events (P = 0.62) and serious adverse events (P = 0.07) did not differ significantly between the group given the biosimilar, and that given the originator.
None of the samples were positive for anti-drug antibodies, indicating no significant immunogenicity concerns.
These results demonstrate that P043/Zerafil, CinnaGen's proposed omalizumab biosimilar, is equivalent to the originator product in the management of asthma, with no significant differences in efficacy, safety, and immunogenicity.
The successful completion of this phase III trial represents a significant advancement in providing patients in Iran and the surrounding region with a cost-effective treatment option for their uncontrolled moderate-to-severe allergic asthma and is a crucial step in developing a biosimilar that could enhance access to this important therapy.
CinnaGen has not yet indicated the next steps for the approval process and potential commercialization of P043/Zerafil [4].
In Europe, Celltrion’s Omlyclo became the first biosimilar omalizumab to be approved in May 2024 [5].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of omalizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 9]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-omalizumab
2. ClinicalTrials.gov. Efficacy and safety of Zerafil® (Omalizumab) in participants with uncontrolled moderate to severe allergic asthma [homepage on the Internet]. [cited 2024 Jul 9]. Available from: https://clinicaltrials.gov/study/NCT05813470
3. Ghanei M, et al. Efficacy and safety of a proposed omalizumab biosimilar compared to the reference product in the management of uncontrolled moderate-to-severe allergic asthma: A multicenter, phase III, randomized, double-blind, equivalency clinical trial. Frontiers Immunol. 2024;15. doi:10.3389/fimmu.2024.1425906
4. Cinnagen. Zerafil® (Omalizumab) [homepage on the Internet]. [cited 2024 Jul 4]. Available from: https://www.cinnagen.com/Product.aspx?t=2&l=1&Id=606&l=1&f=3
5. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of first omalizumab biosimilar Omlyclo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 9]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-first-omalizumab-biosimilar-omlyclo
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