FDA accepts application for high concentration adalimumab biosimilar

Sandoz, the generics division of Novartis, announced on 21 July 2022 that the US Food and Drug Administration (FDA) had accepted the supplemental biologics license application for the high concentration formulation (HCF) of its adalimumab biosimilar Hyrimoz (GP2017) (adalimumab-adaz).

Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Adalimumab is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.

Sandoz is seeking approval for Hyrimoz HCF in the same indications as the reference biological, AbbVie’s Humira (adalimumab), which include rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis.

The application is supported by a comprehensive submission package, which includes a phase I pharmacokinetics bridging study comparing Hyrimoz 50 mg/mL and citrate-free Hyrimoz HCF (100 mg/mL). According to Sandoz, this study met all its primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity between the 50 mg/mL Hyrimoz formulation and Hyrimoz HCF (100 mg/mL).

Hyrimoz 50 mg/mL was approved by FDA in 2018 [1]. The European Medicines Agency (EMA) also accepted the application for Hyrimoz HCF in July 2022 [2].

Sandoz says that the approval of Hyrimoz HCF would build on the ‘already approved and well-established Sandoz global biosimilar portfolio in immunology’. The company goes on to say that it ‘has more than 65 million days of patient experience with Hyrimoz 50 mg/mL worldwide and if approved, Hyrimoz 100 mg/mL citrate-free HCF would represent the first launch of a Sandoz biosimilar in the US market in this specific disease space’.

Sandoz already has four biosimilars approved in the US [3] and 10 in the European Union [4]. The company also claims to have a further 15+ biosimilars in various stages of development.

Another application by Korea-based Samsung Bioepis and partner US-based Organon for their proposed citrate-free, high-concentration (100 mg/mL) adalimumab biosimilar (SB5) was accepted by FDA on 5 January 2022 [5].

Editor’s Comment
Readers interested to learn more about adalimumab biosimilars are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:

Clinical trials supporting the approval of adalimumab biosimilars

Adalimumab copy biological shown to be safe and effective

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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves adalimumab and pegfilgrastim biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 16]. Available from: www.gabionline.net/biosimilars/news/FDA-approves-adalimumab-and-pegfilgrastim-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for high concentration adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 16]. Available from: www.gabionline.net/biosimilars/news/ema-accepts-application-for-high-concentration-adalimumab-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 16]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-the-us
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 16]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
5. GaBI Online - Generics and Biosimilars Initiative. Applications for adalimumab and trastuzumab biosimilars submitted to FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 16]. Available from: www.gabionline.net/biosimilars/news/applications-for-adalimumab-and-trastuzumab-biosimilars-submitted-to-fda

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Source: Sandoz