On 23 February 2024, the US Food and Drug Administration (FDA) approved Alvotech and Teva’s Simlandi (adalimumab-ryvk) injection as an interchangeable biosimilar to AbbVie’s Humira (adalimumab).
Simlandi is the first high-concentration, citrate-free biosimilar to be designated interchangeable to Humira in the US and is the first biosimilar approval under the strategic partnership between Alvotech and Teva in the US market [1].
This is positive news for Alvotech as the company’s previous biologicals licence application (BLA) for their biosimilar adalimumab (also known as AVT02) was rejected by FDA in June 2023. FDA had issued a complete response letter (CRL) for AVT02 which highlighted deficiencies in Alvotech’s Reykjavik manufacturing facility [2].
AbbVie’s originator, Humira, was approved by FDA in December 2002 and by the European Medicines Agency (EMA) in September 2003. The patents on Humira expired in Europe and the US in October 2018 and December 2022, respectively [3].
FDA has now approved 10 biosimilar versions of adalimumab, three with interchangeable status. Simlandi is the latest interchangeable adalimumab, in addition to Pfizer’s Abrilada and Boehringer Ingelheim’s Cyltezo, to compete in the US market, as shown in Table 1 [4].
| Table 1: Biosimilar adalimumab approved in the US*
|
| Product name
|
Active substance
|
Therapeutic area
|
Authorization date
|
Manufacturer/
Company name
|
| Abrilada (adalimumab-afzb)
|
adalimumab
|
Ankylosing spondylitis
Crohn’s disease
Juvenile arthritis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
|
15 Nov 2019
5 Oct 2023§
|
Pfizer
|
| Amjevita (adalimumab-atto)
|
adalimumab
|
Ankylosing spondylitis
Crohn’s disease
Juvenile arthritis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
|
23 Sep 2016
|
Amgen
|
| Cyltezo (adalimumab-adbm)
|
adalimumab
|
Ankylosing spondylitis
Crohn’s disease
Juvenile arthritis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
|
25 Aug 2017
15 Oct 2021§
|
Boehringer Ingelheim
|
| Hadlima (adalimumab-bwwd)
|
adalimumab
|
Ankylosing spondylitis
Crohn’s disease
Juvenile arthritis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
|
23 Jul 2019
|
Samsung Bioepis
|
| Hulio (adalimumab-fkjp)
|
adalimumab
|
Ankylosing spondylitis
Crohn’s disease
Juvenile arthritis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
|
6 Jul 2020
|
Mylan
|
| Hyrimoz (adalimumab-adaz)
|
adalimumab
|
Ankylosing spondylitis
Crohn’s disease
Juvenile arthritis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
|
30 Oct 2018
|
Sandoz
|
| Idacio (adalimumab-aacf)
|
adalimumab
|
Ankylosing spondylitis
Crohn’s disease
Juvenile idiopathic arthritis
Plaque psoriasis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
|
13 Dec 2022
|
Fresenius Kabi
|
| Simlandi (adalimumab-ryvk)
|
adalimumab
|
Ankylosing Spondylitis
Crohn’s Disease
Hidradenitis Suppurativa
Juvenile Idiopathic Arthritis
Plaque Psoriasis
Psoriatic Arthritis
Rheumatoid Arthritis
Ulcerative Colitis
Uveitis
|
23 Feb 2024§
|
Alvotech/Teva
|
| Yuflyma (adalimumab-aaty)
|
adalimumab
|
Ankylosing spondylitis
Crohn disease
Hidradenitis suppurativa
Juvenile idiopathic arthritis
Plaque psoriasis
Psoriatic arthritis
Rheumatoid arthritis
Ulcerative colitis
|
May 2023
|
Celltrion
|
| Yusimry (adalimumab-aqvh)
|
adalimumab
|
Ankylosing spondylitis
Crohn’s disease
Juvenile arthritis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
|
17 Dec 2021
|
Coherus Biosciences
|
*Data updated 11 March 2024.
§Date approved as an interchangeable biosimilar. Semglee was approved as the first interchangeable biosimilar in the US on 28 July 2021 [5].
AMD: age-related macular degeneration; FDA: US Food and Drug Administration; mCNV: myopic choroidal neovascularization; NSCLC: non-small-cell lung carcinoma; ODAC: Oncologic Drugs Advisory Committee; RVO: retinal vein occlusion.
|
Simlandi has gained approval for interchangeable exclusivity in the US for the 40mg/0.4ml injection, joining the market alongside other biosimilars of Humira. Notably, approximately 88% of adalimumab prescriptions in the US are for the high-concentration presentation.
The interchangeability designation will allow for Simlandi to substitute for Humira at the pharmacy level without requiring a pharmacist to obtain prescriber’s permission, subject to state pharmacy laws [5]. Simlandi one of a eighth biosimilars in the US to be given the interchangeability designation, others include Abrilada (adalimumab-afzb), Byooviz (ranibizumab-runa), Cimerli (ranibizumab-eqrn), Cyltezo (adalimumab-adbm), Rezvoglar (insulin glargine-aglr), Semglee (insulin glargine-yfgn) and Wezlana (ustekinumab-auub).
The FDA approval of Simlandi was based on a totality of evidence, including analytical, non-clinical and clinical data. This included data from the AVT02-GL-101 Phase 1 trial which showed PK similarity; the AVT02-GL-301 Phase 3 trial, where Simlandi demonstrated similar efficacy, and compare safety and immunogenicity to Humira in patients with moderate-to-severe chronic plaque psoriasis; and the AVT02-GL-302 Phase 3 trial, which demonstrated similar PK, and comparable efficacy, safety, and immunogenicity between patients receiving Humira and patients undergoing repeated switches between Humira and SIMLANDI for moderate to severe chronic plaque psoriasis.
The interchangeability designation is designed to increase access to the biosimilar and convenience for patients.
Related articles
Humira (adalimumab) biosimilars pipeline
US Senate clarifies status of interchangeable biosimilar exclusivity
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References
1. GaBI Online - Generics and Biosimilars Initiative. Fresenius Kabi and Formycon reach agreement with J&J, Alvotech and Teva expand partnership [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Mar 11]. Available from: www.gabionline.net/pharma-news/fresenius-kabi-and-formycon-reach-agreement-with-j-j-alvotech-and-teva-expand-partnership
2. GaBI Online - Generics and Biosimilars Initiative. Alvotech: rejection AVT02 in the US and new partnerships with Prolifarma and Advanz Pharma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Mar 11]. Available from: www.gabionline.net/biosimilars/news/alvotech-rejection-avt02-in-the-us-and-new-partnerships-with-prolifarma-and-advanz-pharma
3. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Mar 11]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-the-us
5. GaBI Online - Generics and Biosimilars Initiative. FDA releases new information on interchangeable biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Mar 11]. Available from: www.gabionline.net/biosimilars/general/FDA-releases-new-information-on-interchangeable-biologicals
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