FDA approves adalimumab biosimilar Cyltezo as interchangeable

Biosimilars/News | Posted 29/10/2021 post-comment0 Post your comment

The US Food and Drug Administration (FDA) has approved the first interchangeable adalimumab biosimilar. This is the second interchangeable biosimilar to gain FDA approval in the US and follows the landmark decision to approve an interchangeable insulin glargine biosimilar in July 2021 [1].

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The agency announced on 18 October 2021 that on 15 October 2021 it had approved the adalimumab biosimilar Cyltezo (adalimumab-adbm) as the first interchangeable biosimilar to the reference product Humira (adalimumab).

The biosimilar is made by Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim). The company received approval from FDA for Cyltezo (BI 695501) on 25 August 2021 for the same indications as the reference product (AbbVie’s Humira), including ankylosing spondylitis (an arthritis that affects the spine), Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis [2].

This new ‘interchangeable’ status means that Cyltezo may now be substituted for the reference product (AbbVie’s Humira) without the intervention of the prescriber. The substitution may occur at the pharmacy, a practice commonly called ‘pharmacy-level substitution’—much like how generics are substituted for brand-name drugs, subject to state pharmacy laws, which vary by state [3].

Cyltezo was also approved in Europe back in November 2017 but was withdrawn by Boehringer Ingelheim in January 2019 [4] after the company decided to pull out of the European biosimilars market and focus on the US [5].

Cyltezo is the second interchangeable biosimilar approved by FDA and the first interchangeable monoclonal antibody approved in the US.

Acting FDA Commissioner, Dr Janet Woodcock, said that the agency continues to be steadfast in its ‘commitment to provide patients with alternative high-quality, affordable medications that are proven to be safe and effective’. She added that ‘the biosimilar and interchangeable approval pathway was created to help increase access to treatment options for patients with serious medical conditions.’

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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable insulin glargine biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 29]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-insulin-glargine-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves adalimumab biosimilar Cyltezo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 29]. Available from: www.gabionline.net/biosimilars/news/FDA-approves-adalimumab-biosimilar-Cyltezo
3. GaBI Online - Generics and Biosimilars Initiative. 45 US states have passed biosimilar substitution laws [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 29]. Available from: www.gabionline.net/policies-legislation/45-US-states-have-passed-biosimilar-substitution-laws
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 29]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-Europe
5. GaBI Online - Generics and Biosimilars Initiative. Boehringer Ingelheim and Sandoz abandon biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 29]. Available from: www.gabionline.net/biosimilares/general/Boehringer-Ingelheim-and-Sandoz-abandon-biosimilars

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Source: EMA, US FDA

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