Boehringer Ingelheim starts phase III interchangeability trial for adalimumab biosimilar

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Boehringer Ingelheim starts phase III interchangeability trial for adalimumab biosimilar

Biosimilares/Novedades | Posted 08/09/2017 0 Post your comment

Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) announced on 27 July 2017 that the first patient had been enrolled into the phase III VOLTAIRE‑X interchangeability study of its adalimumab biosimilar (BI 695501). The company says the trial ‘is the first study in the US to investigate an interchangeability designation for an adalimumab biosimilar candidate’.

Boehringer Ingelheim’s drug is a biosimilar version of AbbVie’s blockbuster autoimmune disease treatment Humira (adalimumab). Humira is a tumour necrosis factor (TNF) inhibitor that is approved to treat rheumatoid, juvenile rheumatoid and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.

The trial is a randomized, double-blind, parallel-arm, multiple-dose, active comparator study. The main objective of the study is to assess the pharmacokinetic similarity between patients receiving Humira continuously versus those who alternate between BI 695501 and Humira in patients with moderate-to-severe chronic plaque psoriasis. The study will also assess safety, immunogenicity and efficacy.

The trial will include 240 patients, aged 18−80 years and is expected to be completed in July 2019.

BI 695501 was accepted for regulatory review by the European Medicines Agency and the US Food and Drug Administration (FDA) in January 2017 [1] and was approved by FDA in August 2017 [2]. Phase III results demonstrating clinical equivalence of BI 695501 to Humira in people living with rheumatoid arthritis were presented at the annual European Congress of Rheumatology in June 2017 [3].

Sales for Humira, the world’s top-selling prescription drug, were almost US$10.7 billion in 2013, accounting for almost 60% of AbbVie’s total sales. The patents on Humira expire in the European Union in 2016 and in the US in 2018 [4].

References
1. GaBI Online - Generics and Biosimilars Initiative. Boehringer Ingelheim submits biosimilar adalimumab application to both EMA and FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 8]. Available from: www.gabionline.net/Biosimilars/News/Boehringer-Ingelheim-submits-biosimilar-adalimumab-application-to-both-EMA-and-FDA
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves adalimumab biosimilar Cyltezo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 8]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-adalimumab-biosimilar-Cyltezo
3. GaBI Online - Generics and Biosimilars Initiative. Boehringer Ingelheim’s adalimumab biosimilar ‘equivalent’ to Humira [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 8]. Available from: www.gabionline.net/Biosimilars/Research/Boehringer-Ingelheim-s-adalimumab-biosimilar-equivalent-to-Humira
4. Derbyshire M. Patent expiry dates for biologicals: 2016 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(1):27-30. doi:10.5639/gabij.2017.0601.006

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Source: Boehringer Ingelheim, ClinicalTrials.gov