FDA approval for Amgen’s infliximab biosimilar Avsola

Biosimilars/News | Posted 13/12/2019 post-comment0 Post your comment

US-based biotech giant Amgen announced on 6 December 2019 that it had received approval from the US Food and Drug Administration (FDA) for its infliximab biosimilar Avsola (ABP 710).

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Infliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α). It is used to treat autoimmune diseases, such as ankylosing spondylitis (AS), Crohn’s disease (CD), psoriasis, psoriatic arthritis (PsA), rheumatoid arthritis (RA), and ulcerative colitis (UC).

The FDA’s approval of the infliximab biosimilar, which will be called Avsola (infliximab-axxq), is based on review of evidence that included results from a pharmacokinetic (PK) similarity study conducted in healthy subjects, and a comparative clinical study conducted in patients with moderate to severe RA. According to Amgen, the data proved Avsola ‘to be highly similar to Remicade with no clinically meaningful differences based on a totality of evidence, which included comparative analytical, nonclinical and clinical data’.

Avsola has been approved for all approved indications of the reference product, Johnson & Johnson and Merck’s Remicade (infliximab). Avsola is therefore approved for the treatment of moderate-to-severe RA, moderate-to-severe CD in the adult and paediatric population, moderate-to-severe UC in the adult and paediatric population, chronic severe plaque psoriasis (PsO), PsA and AS.

The randomized, double-blind comparative clinical study evaluated the efficacy and safety of Avsola compared to Remicade in patients with moderate-to-severe RA. A total of 558 patients were enrolled and randomized (1:1) to receive either Avsola or Remicade at a dose of 3 mg/kg administered as an infusion on day 1, at Weeks 2 and 6, and every 8 Weeks thereafter. The primary endpoint was the response difference (RD) of 20% improvement in American College of Rheumatology core set measurements (ACR20) at Week 22. Key secondary endpoints included DAS28-CRP change from baseline, RD of ACR20, ACR50 and ACR70 at Weeks 2, 6, 14, 22, 30, 34, 38, 46 and 50. The study also incorporated the evaluation of a single transition in 119 subjects from Remicade to Avsola at Week 22, which demonstrated similar safety and immunogenicity in patients who were previously on Remicade [1].

The approval marks the fourth FDA-approved biosimilar for Amgen [2]. The company says that it has 10 biosimilars in its portfolio and has also received approval for three biosimilars in Europe [3].

Avsola has, however, only been approved as a biosimilar, not as an interchangeable product. According to the Biologics Price Competition and Innovation Act, only a biological that has been approved as interchangeable may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product.

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1. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for Amgen’s infliximab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Dec 13]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-results-for-Amgen-s-infliximab-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Dec 13]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Dec 13]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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Source: Amgen

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