Phase I trials have started for proposed biosimilars of aflibercept and ustekinumab.
South Korean biologicals company Alteogen has, according to clinicaltrials.gov, started a phase I trial for its candidate aflibercept biosimilar ALT-L9.
Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor. It is indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy in patients with diabetic macular edema.
Alteogen announced in January 2019 that it had been granted a process patent for its method of producing an aflibercept biosimilar, ALT‑L9, referencing Regeneron’s blockbuster drug Eylea (aflibercept) [1]. The company then gained approval from the Korean Ministry of Food and Drug Safety (MFDS) to initiate a clinical trial for its aflibercept biosimilar, ALT‑L9, in May 2019 [2].
The phase I trial of ALT-L9 will be conducted in South Korea. It will be a two-arm, randomized, quadruple-blind, study comparing the safety, efficacy and pharmacokinetics (PKs) of repeated (4-weekly) intravitreal administration of ALT-L9 at a dose of 2 mg/50 uL versus Eylea in 30 patients aged ≥ 50 years with neovascular age-related macular degeneration. Alteogen expects to complete the study in December 2020.
German biosimilars company Formycon announced on 28 October 2019 the start of a phase I clinical trial of its proposed ustekinumab biosimilar, FYB202, in the second half of 2019. In fact, dosing of study subjects has already started in the clinical trial, which compares the PKs, safety, and tolerability of FYB202 and the reference product Stelara (ustekinumab).
Ustekinumab is a humanized monoclonal antibody that interferes with the triggering of the body’s inflammatory response through the suppression of certain cytokines. Specifically, it blocks interleukin IL 12 and IL 23 which help activate certain T cells. It binds to the p 40 subunit of both IL 12 and IL 23 so that they subsequently cannot bind to their receptors. It is indicated for the treatment of Crohn’s disease, psoriasis and psoriatic arthritis.
Formycon developed FYB202 with Germany-based Aristo Pharma, and already announced that the product had achieved ‘key milestones’ in the ‘pilot phase’ of its development [3]. Formycon expects to launch FYB202 once the patents on Stelara have expired [4] and ‘provided successful completion of clinical phase I and subsequent phase III testing and timely regulatory approval’.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Alteogen wins process patent for aflibercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 15]. Available from: www.gabionline.net/Biosimilars/General/Alteogen-wins-process-patent-for-aflibercept-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. Alteogen gains approval to start aflibercept biosimilar trial in Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 15]. Available from: www.gabionline.net/Biosimilars/News/Alteogen-gains-approval-to-start-aflibercept-biosimilar-trial-in-Korea
3. GaBI Online - Generics and Biosimilars Initiative. NeuClone to start phase I trial for ustekinumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 15]. Available from: www.gabionline.net/Biosimilars/News/NeuClone-to-start-phase-I-trial-for-ustekinumab-biosimilar
4. 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
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Source: clinicaltrials.gov, Formycon
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