EMA and FDA accept application for adalimumab biosimilar AVT02 Posted 08/01/2021

Iceland-based biopharmaceutical company Alvotech announced on 19 November 2020 that its US subsidiary, Alvotech USA, had filed an application for its adalimumab biosimilar (AVT02). The company also announced that the European Medicines Agency (EMA) had accepted for review its application for AVT02 with an EMA decision anticipated in the fourth quarter of 2021.

AVT02 is a proposed biosimilar of AbbVie’s Humira. In 2018, this originator biological drug was the largest selling medicine worldwide with sales of US$20 billion [1].

Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF), a soluble inflammatory cytokine. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Adalimumab is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.

The filings are based on the results of a comprehensive development programme and data package that, according to Alvotech, demonstrated ‘a high degree of similarity of AVT02 compared to its reference product’.

Data was included from Alvotech’s phase III trial of AVT02 (ALVOPAD PS), which was started in March 2019, as well as from its phase I study of the safety, tolerability, and pharmacokinetics (PK) of AVT02 and a phase I study comparing the safety, tolerability and PK of AVT02 and Humira in healthy volunteers (ALVOPAD) in August 2018 [2].

Key results, according to Alvotech, included that:

  • AVT02 is highly similar to its reference product in terms of structure and function, which was assessed using a comprehensive set of state-of-the-art and orthogonal analytical methods.
  • Pharmacokinetic similarity of AVT02 to its reference product was established in the comparative pharmacokinetic study AVT02-GL-101 following subcutaneous administration of AVT02 or the reference products to healthy subjects at a single dose of 40 mg.
  • The comparative clinical efficacy and safety study AVT02-GL-301 established the therapeutic equivalence of AVT02 to its reference product in the sensitive population of subjects with moderate to severe chronic psoriasis with similar efficacy, and comparable safety, tolerability, and immunogenicity profiles.

The proposed biosimilar will be available in high concentration (100 mg/mL) dosage forms that, according to Alvotech, ‘are expected to be beneficial to patients and to be differentiated from most biosimilar competitors, while matching the newest dosage forms of the reference product’.

AVT02 is one of five product candidates from Alvotech that will be commercialized, upon approval, by Teva Pharmaceuticals in the US following an exclusive strategic partnership announced earlier in 2020.

In Europe, as well as in selected markets outside Europe, AVT02 is one of seven product candidates from Alvotech that will be commercialized by STADA following an exclusive strategic partnership announced in 2019.

The company also made an agreement with Cipla Gulf in July 2019 for the commercialization of AVT02 in a selection of emerging markets [1].

Related article
Biosimilars of adalimumab

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References
1. GaBI Online - Generics and Biosimilars Initiative. Alvotech and Cipla Gulf partnership announced [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 8]. Available from: www.gabionline.net/Pharma-News/Alvotech-and-Cipla-Gulf-partnership-announced 
2. GaBI Online - Generics and Biosimilars Initiative. Phase III clinical trials started for adalimumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 8]. Available from: www.gabionline.net/Biosimilars/Research/Phase-III-clinical-trials-started-for-adalimumab-biosimilars

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Source: Alvotech

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