US-based Kashiv Biosciences announced that ADL018, a biosimilar candidate to Xolair (omalizumab), has completed a successful global phase I clinical study in healthy volunteers. In addition, South Korea’s Celltrion announced that it received approval from the US Food and Drug Administration for the phase III investigational new drug (IND) application of its biosimilar CT-P53 for Ocrevus (ocrelizumab), a treatment for multiple sclerosis.
Kashiv phase I trial results of omalizumab biosimilar ADL018
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]. Omalizumab is used to treat asthma, as well as nasal polyps and chronic idiopathic urticaria (itchy rash). It is sold under the brand name Xolair by Novartis.
According to IQVIA, worldwide and U.S. annual sales for Xolair for the 12 months ended December 2022 were ~ US$4.0 billion and US$2.8 billion, respectively.
The ADL018 phase I trial was a randomized, double-blind, comparative pharmacokinetic (PK) study. Subjects received either ADL018, EU-approved omalizumab, or US-licensed omalizumab via subcutaneous injection. The primary objective was to demonstrate PK similarity and compare the safety and tolerability. Kashiv representatives announced successful phase I trial results in July 2023.
Celltrion conducts phase III trial for ocrelizumab biosimilar in US
Celltrion’s IND approval for their phase III trial of CT-P53 was announced in June 2023.
The company now plans to conduct comparative studies on efficacy, pharmacokinetics and safety between CT-P53 and the originator drug Ocrevus in a total of 512 relapsing-remitting multiple sclerosis patients.
Ocrevus was developed by Roche and is used for the treatment of relapsing-remitting multiple sclerosis and primary progressive multiple sclerosis. It has recorded global sales of approximately US$7 billion in 2022. It holds the top position in the global multiple sclerosis market, with the US market accounting for over 70% of the total market size at US$5.2 billion.
This biosimilar adds to Celltrion’s expanding pipeline of biosimilars [2] that includes: CT-P39 (Xolair), CT-P43 (Stelara), CT-P42 (Eylea), CT-P41 (Prolia) and CT-P47 (Actemra), which it hopes will be approved in the US in due course.
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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 2023 Jul 24]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-omalizumab
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilar pipelines for South Korean firms: Celltrion and Samsung Bioepis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jul 24]. Available from: www.gabionline.net/biosimilars/general/biosimilar-pipelines-for-south-korean-firms-celltrion-and-samsung-bioepis
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