In June 2024, Celltrion announced promising results from their Phase III study for CT-P47, a biosimilar candidate of RoActemra (tocilizumab), in patients with rheumatoid arthritis (RA). Additionally, the company has submitted an investigational new drug (IND) application to the US Food and Drug Administration (FDA) for the phase III clinical trial of CT-P51, its Keytruda (pembrolizumab) biosimilar. This announcement follows the news that in April 2024, rival Korean biologicals company Samsung Bioepis initiated a Phase III clinical trial for SB27, their pembrolizumab biosimilar.
Celltrion’s tocilizumab biosimilar results
Tocilizumab is a humanized monoclonal antibody which acts against the interleukin-6 receptor (IL-6R). It is an immunosuppressive drug used mainly for the treatment of rheumatoid arthritis and systemic juvenile idiopathic arthritis, a severe form of arthritis in children [1]. Tocilizumab biosimilars have already been approved in the US [2] and Europe [3, 4].
Celltrion presented their positive Phase III data for CT-P47 in patients with moderate-to-severe rheumatoid arthritis (RA), at the Annual European Congress of Rheumatology (EULAR) 2024. Data from the Phase III comparative clinical trial demonstrated that CT-P47, has an equivalent efficacy, and comparable safety and immunogenicity profile to the reference tocilizumab product.
In addition, they announced the successful results of a Phase I/III study that compared pharmacokinetic (PK) similarity between the CT-P47 autoinjector (AI) and the pre-filled syringe (PFS).
Pembrolizumab biosimilar advances
Merck/MSD’s Keytruda (pembrolizumab) is a humanized (from mouse) monoclonal antibody that binds to, and blocks PD-1 located on lymphocytes. It is an anticancer medication used in the treatment of melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, urothelial cancer (cancer of the bladder and urinary tract) and renal cell carcinoma (kidney cancer) [5].
Keytruda was approved by FDA in September 2014 and by EMA in July 2015 and its patents in these regions are due to expire in 2028 [6]. Keytruda is the best-selling oncology drug, it also secured the top spot as the highest-selling drug across all treatment spaces in 2023, generating US$25bn.
Celltrion’s global clinical trial of CT-P51, its pembrolizumab biosimilar will evaluate the efficacy equivalence between CT-P51 and the original Keytruda in 606 patients with metastatic non-small cell lung cancer (NSCLC).
Samsung Bioepis has already started the Phase III clinical trial for SB27, a pembrolizumab biosimilar. It is a randomized, double-blind, parallel group, multi-centre study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB27 and Keytruda in patients with NSCLC.
Alvotech also has a Keytruda biosimilar in the pipeline, AVT33 [7], as does Formycon [8].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of tocilizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 3]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-tocilizumab
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves ustekinumab trastuzumab, and tocilizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 3]. Available from: www.gabionline.net/biosimilars/news/fda-approves-ustekinumab-trastuzumab-and-tocilizumab-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of biosimilar tocilizumab Tofidence and ustekinumab Wezenla [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 3]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-biosimilar-tocilizumab-tofidence-and-ustekinumab-wezenla
4. GaBI Online - Generics and Biosimilars Initiative. EC approval of natalizumab, aflibercept and tocilizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 3]. Available from: www.gabionline.net/biosimilars/news/ec-approval-of-natalizumab-aflibercept-and-tocilizumab-biosimilars
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pembrolizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 3]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-pembrolizumab
6. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
7. GaBI Online - Generics and Biosimilars Initiative. Advances for Alvotech’s partnerships in Japan, Canada and Switzerland [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 3]. Available from: www.gabionline.net/biosimilars/news/advances-for-alvotech-s-partnerships-in-japan-canada-and-switzerland
8. GaBI Online - Generics and Biosimilars Initiative. Forwards for Formycon’s Keytruda and backwards for Prestige’s Herceptin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 3]. Available from: www.gabionline.net/biosimilars/news/forwards-for-formycon-s-keytruda-and-backwards-for-prestige-s-herceptin
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