Applications for adalimumab and trastuzumab biosimilars submitted to FDA

Biosimilars/News | Posted 04/02/2022 post-comment0 Post your comment

Korea-based Samsung Bioepis and partner US-based Organon announced on 5 January 2022 that the US Food and Drug Administration (FDA) had accepted the application for their proposed citrate-free, high-concentration (100 mg/mL) adalimumab biosimilar (SB5). A low-concentration formulation of SB5, Hadlima (adalimumab-bwwd), was approved in the US in July 2019 [1].

Application V15a16

SB5 is a proposed biosimilar to AbbVie’s Humira (adalimumab), which had worldwide sales of US$19.8 billion in 2020. The patents on Humira expired in the US in November 2017 and in Europe in June 2017 [2].

The application for the citrate-free, high-concentration adalimumab biosimilar was submitted by Samsung Bioepis in October 2021. The application is based on clinical data from a randomized, single-blind, two-arm, parallel group, single-dose study that compares the pharmacokinetics, safety, tolerability and immunogenicity of two formulations of SB5 (100 mg/mL versus 50 mg/mL) in healthy volunteers.

SB5 will be commercialized in the US by Organon. It is expected to launch in the US on or after 1 July 2023, in accordance with a licensing agreement with AbbVie. In fact, AbbVie has made nine such deals with biosimilars’ makers delaying the launch of adalimumab biosimilars until 2023 [3]. This, in contrast to Europe where adalimumab biosimilars have been available since 2018 [4].

Sandoz, the generics division of Novartis, announced on 20 December 2021 that it had submitted the application for approval of its candidate trastuzumab biosimilar (EG12014) to FDA. The application is supported by analytical, preclinical and clinical data.

EG12014 is a proposed biosimilar to Roche’s Herceptin (trastuzumab) which had worldwide sales of CHF 7.0 billion (US$7.5 billion) in 2018, before the advent of biosimilars. The patents on Herceptin expired in the US in June 2019 and in Europe in July 2014 [1].

The proposed trastuzumab biosimilar was developed by Taiwan-based EirGenix. Sandoz signed an agreement with EirGenix back in April 2019 giving Sandoz exclusive rights to globally commercialize the proposed trastuzumab biosimilar (EG12014) in all markets except China and Taiwan [5].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Feb 4]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-approved-in-the-US
2. 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
3. GaBI Online - Generics and Biosimilars Initiative. Boehringer Ingelheim finally signs licensing deal for Humira biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Feb 4]. Available from: www.gabionline.net/pharma-news/Boehringer-Ingelheim-finally-signs-licensing-deal-for-Humira-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Feb 4]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
5. GaBI Online - Generics and Biosimilars Initiative. Sandoz and EirGenix make deal for trastuzumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Feb 4]. Available from: www.gabionline.net/pharma-news/Sandoz-and-EirGenix-make-deal-for-trastuzumab-biosimilar

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Source: Organon, Sandoz

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