Positive phase III data for adalimumab biosimilar Cyltezo

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Positive phase III data for adalimumab biosimilar Cyltezo

Biosimilars/Research | Posted 23/11/2018 0 Post your comment

Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) announced on 12 September 2018 positive phase III data for its adalimumab biosimilar, Cyltezo [1]. The results, according to Boehringer Ingelheim ‘confirm that Cyltezo is equivalent to Humira, with no clinically meaningful differences in efficacy safety and immunogenicity in people with moderate-to-severe chronic plaque psoriasis’.

The phase III, randomized, double-blind, parallel-arm, multiple-dose, active comparator trial enrolled 318 patients 18−78 years of age with moderate-to-severe chronic plaque psoriasis, who had not previously received treatment with one or more biological. Patients received biosimilar adalimumab, Cyltezo (BI 695501), or originator adalimumab, Humira, at 80 mg on Day 1, 40 mg on Day 7 and 40 mg every other week thereafter.

The primary endpoint, which measured the proportion of patients achieving a 75% reduction in Psoriasis Area Severity Index (PASI) at Week 16, was met.

These results, according to Kay Tetzlaff, Vice President and Medical Head of Therapeutic Area Biosimilars at Boehringer Ingelheim, ‘build on recent evidence that demonstrates Cyltezo is equivalent to Humira for the treatment of moderately-to-severely active rheumatoid arthritis’.

These data were used to support the approval of Cyltezo by the European Commission (EC) and the US Food and Drug Administration (FDA). Cyltezo was approved by FDA in August 2017 [1] and by the EC in November 2018 [2].

Boehringer Ingelheim says that it will present the 24-week data from this study in 2019. In addition, the company says it is conducting a clinical trial to demonstrate the interchangeability between Cyltezo and Humira. This, according to Boehringer Ingelheim, is the first study in the US to investigate an interchangeability designation for an adalimumab biosimilar.

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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves adalimumab biosimilar Cyltezo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 23]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-adalimumab-biosimilar-Cyltezo
2. GaBI Online - Generics and Biosimilars Initiative. EC approval for adalimumab biosimilar Cyltezo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 23]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-adalimumab-biosimilar-Cyltezo

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Source: Boehringer Ingelheim