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Phase III clinical trials started for adalimumab biosimilars Posted 05/04/2019

Phase III clinical trials have been started for adalimumab biosimilars from Alvotech and Celltrion.

Iceland-based biopharmaceutical company Alvotech announced on 13 March 2019 that it had enrolled its first patient in its phase III trial of its candidate adalimumab biosimilar, AVT02. The company also has a phase I study of the safety, tolerability, and pharmacokinetics of the proposed biosimilar already ongoing in Australia. It also completed a phase I study comparing the safety, tolerability and pharmacokinetics of AVT02 and Humira in healthy volunteers (ALVOPAD) in August 2018.

The phase III trial is a multicentre, double-blind, randomized, parallel-group, active controlled study to compare the efficacy, safety and immunogenicity of AVT02 versus the originator adalimumab, Humira, in patients with moderate-to-severe chronic plaque psoriasis (ALVOPAD PS).

Alvotech says that its formulation for the candidate adalimumab biosimilar contains a high concentration of adalimumab. This, according to Alvotech, could be more convenient for patients by potentially reducing the injection volume. It could also be a differentiating point for the company, helping it to compete against the many adalimumab biosimilars expected to be approved in the coming years in both Europe and the US.

The company is aiming to enrol 400 participants in the trial at 30 sites across Europe and expects the trial to be completed in August 2020.

And on 28 March 2019, South Korean biotechnology company Celltrion announced that it had completed registering patients for its global phase III clinical trial of its candidate adalimumab biosimilar, CT P17.

The phase III trial is a randomized, active-controlled, double-blind study to compare the efficacy and safety of CT P17 with Humira in patients with active rheumatoid arthritis.

Celltrion is also trying to differentiate its drug from competitors by developing CT P17 as a high-concentration formulation. The company has also developed CT P17 as a citrate free formulation, which can reduce the pain of the injection as it does not have a citrate buffer.

The company is aiming to enrol 564 participants in the trial, which will be carried out in Bulgaria, and expects the trial to be completed in June 2020.

There are already three adalimumab biosimilars approved in the US [1] and 10 in Europe [2].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 5]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe 
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 5]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US

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Source: clinicaltrials.gov

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