FDA approves interchangeable adalimumab biosimilar Simlandi

Biosimilars/News | Posted 11/03/2024 post-comment0 Post your comment

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).

MD002152

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 Therapeutic area Authorization date Manufacturer/
Company name
Abrilada (adalimumab-afzb) Ankylosing spondylitis
Crohn’s disease
Juvenile arthritis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
15 Nov 2019
5 Oct 2023§
Pfizer
Amjevita (adalimumab-atto) Ankylosing spondylitis
Crohn’s disease
Juvenile arthritis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
23 Sep 2016 Amgen
Cyltezo (adalimumab-adbm) 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) Ankylosing spondylitis
Crohn’s disease
Juvenile arthritis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
23 Jul 2019 Samsung Bioepis
Hulio (adalimumab-fkjp) Ankylosing spondylitis
Crohn’s disease
Juvenile arthritis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
6 Jul 2020 Mylan
Hyrimoz (adalimumab-adaz) Ankylosing spondylitis
Crohn’s disease
Juvenile arthritis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
30 Oct 2018 Sandoz
Idacio (adalimumab-aacf) 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)  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) Ankylosing spondylitis
Crohn disease
Hidradenitis suppurativa
Juvenile idiopathic arthritis
Plaque psoriasis
Psoriatic arthritis
Rheumatoid arthritis
Ulcerative colitis
May 2023 Celltrion
Yusimry (adalimumab-aqvh)  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

LATIN AMERICAN FORUM
The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View the latest headline article: La FDA aprueba el biosimilar intercambiable de adalimumab Simlandi

Browse the news in the Latin American Forum!

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.

FORO LATINOAMERICANO
Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Ver el último artículo de cabecera: La FDA aprueba el biosimilar intercambiable de adalimumab Simlandi

!Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. 

 

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2024 Pro Pharma Communications International. All Rights Reserved.

 

comment icon Comments (0)
Post your comment
Related content
FDA approves filgrastim biosimilar Nypozi
Filgrastim Grastofil V13H23
Biosimilars/News Posted 04/09/2024
FDA approves third aflibercept biosimilar Ahzantive
Bevacizumab VEGF Lucentis V21D02MN
Biosimilars/News Posted 13/08/2024
China approves Simcare’s cetuximab beta Enlituo
Cancer Cell V13I20
Biosimilars/News Posted 30/07/2024
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010