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Long-term safety results for adalimumab biosimilar Posted 02/08/2019

ABP 501 is an adalimumab biosimilar which was compared to reference adalimumab in a 24-week phase lll study demonstrating equivalent efficacy and similar safety and immunogenicity [1]. The results of this clinical trial, along with the totality of evidence from analytical and biofunctional evaluation, lead to the approval of this adalimumab biosimilar for rheumatoid arthritis in the European Union and the US. ABP 501 is marketed as Amgevita in Europe and other markets. However, it will not be available in the US until 2023 due to an agreement between Amgen, the developer of the biosimilar, and AbbVie who manufactures the originator product, Humira (adalimumab) [2].

ABP 501 was subsequently evaluated in a phase III, single-arm, open-label extension (OLE) study to collect additional longer-term safety and efficacy data in patients with rheumatoid arthritis (RA) [3]. A total of 494 subjects completed the final visit in the parent 24-week phase III randomized, double-blind study and 466 were enrolled in this OLE study. All subjects received 40 mg ABP 501 every other week for an additional 68 weeks. Among the 466 patients treated with ABP 501, 229 transitioned from the ABP 501 arm of the parent study (ABP 501/ABP 501) and 237 from the adalimumab reference product arm (RP/ABP 501); 412/466 (88.2%) patients completed the study. The American College of Rheumatology 20% improvement criteria (ACR20) response rate was 73.3% (340/464 subjects) at OLE baseline and 78.8% (327/415 subjects) at Week 70 of the OLE study. The overall mean change in Disease Activity Score 28-joint count C reactive protein (DAS28-CRP) from the parent study baseline was -2.25 at the OLE study baseline (n = 440), -2.36 at Week 4 (n = 463), -2.41 at Week 24 (n = 450), -2.55 at Week 48 (n = 433) and -2.60 at Week 70 n = 412).

The overall incidence of treatment related adverse events (TEAEs) was 63.7% (297/466); grade ≥3 TEAE incidence was 9.0% (42/466). The incidence of TEAEs leading to discontinuation of investigational product was 3.6% (17/466). The incidence of serious adverse events (SAEs) was 9.9% (46/466). Overall, 18.2% (85/466) of subjects developed binding anti‐drug antibodies (ADAs) and 6.9% (32/466) developed neutralizing ADAs in the OLE study.

Efficacy was maintained throughout the study, as previously demonstrated in the parent study [4], with no new safety findings. Long-term safety, immunogenicity and efficacy were similar in the ABP 501/ABP 501 and RP/ABP 501 groups. This study demonstrated persistence of benefit with the adalimumab biosimilar with no loss of efficacy or increased safety issues with the single switch from reference adalimumab. These results are similar to those reported with numerous other adalimumab biosimilars [5]. The results in clinical practice have mirrored the clinical trial results and the availability of multiple biosimilars has resulted in significant cost savings to healthcare systems where these therapies are available.

Conflict of interest
The author of the research paper [1] reported conflict of interest, including being employees of pharmaceutical companies. For full details of the authors’ conflict of interest, see the research paper [1].

Abstracted by Stanley Cohen, Internal Medicine, Rheumatology Division, Metroplex Clinical Research Center, Suite 800, 8144 Walnut Hill Lane, Dallas, TX 75231, USA.

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1. Cohen S, Pablos JL, Pavelka K, Müller GA, Matsumoto A, Kivitz A, et al. An open-label extension study to demonstrate long-term safety and efficacy of ABP 501 in patients with rheumatoid Arthritis. Arthritis Res Ther. 2019;21(1):84.
2. GaBI Online - Generics and Biosimilars Initiative. Amgen’s adalimumab biosimilar will only be launched in US in 2023 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 2]. Available from: www.gabionline.net/Biosimilars/News/Amgen-s-adalimumab-biosimilar-will-only-be-launched-in-US-in-2023 
3. Cohen S, Pablos JL, Pavelka K, et al. An open-label extension study to demonstrate long-term safety and efficacy of ABP 501 in patients with rheumatoid arthritis. Arthritis Res Ther. 2019;21(1):84.
4. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for rituximab biosimilar ABP 798 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 2]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-results-for-rituximab-biosimilar-ABP-798 
5. Cohen S, Kay J. Biosimilars: implications for rheumatoid arthritis therapy. Curr Opin Rheumatol. 2017;29(3):260-8.

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