Study: Biosimilarities Found Between Yusimry and Humira for Immune, Rheumatic Conditions

Investigators have found biosimilarities between biosimilar adalimumab-aqvh (Yusimry; Coherus Biosciences) and the reference drug adalimumab (Humira; AbbVie), according to results of a study published in Drugs in R&D.¹

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In December 2021, adalimumab-aqvh was approved by the FDA for the treatment of plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn disease, and ulcerative colitis, according to a press release from Coherus.² Both adalimumab-aqvh and the reference drug are immunoglobulin G1 recombinant monoclonal antibodies, according to the study authors.¹

In July 2023, 8 adalimumab biosimilars entered the biosimilar market, including adalimumab-aqvh. For adalimumab-aqvh, Coherus Biosciences partnered with the Mark Cuban Cost Plus Drug Company, though the partnership led to a preliminary injunction filed by AbbVie. The 2 companies agreed to settle the dispute since filing.³

In the study, investigators aimed to determine whether adalimumab-aqvh has physiochemical and functional similarities to reference adalimumab, and the study was part of the biologics license application that led to the approval of adalimumab-aqvh as a biosimilar to adalimumab, according to the study authors.¹

In the study, investigators used 17 independent lots of adalimumab-aqvh and 43 lots of adalimumab, with expiration dates more than 6 years in the future. They used “state-of-the-art physiochemical and functional assays” to help evaluate adalimumab-aqvh and adalimumab, specifically considering known physicochemical characteristics and plausible mechanisms of action of the reference product, according to the study authors.¹ Structural and functional assays were used to help identify differences in either product as well as to categorize those differences.¹

In the structural data, the study authors reported that both products had identical amino acid sequences and disulfide structures. Adalimumab-aqvh also met the similarity criteria for high mannose, afucose, and total afucose, but not terminal galactorse or sialic acid, according to the results. Also, adalimumab-aqvh did not meet similarity criteria compared to adalimumab for protein concentration due to 2 lots having slightly higher values. However, after process improvements, the study authors reported that all other lots were within the similarity range, according to the results.¹

Furthermore, most quantitative similarity criteria were met by adalimumab-aqvh, including size variants by size exclusion with ultra-performance liquid chromatography and reduced capillary electrophoresis in sodium dodecyl sulfate (CE–SDS) and charge variants by cation-exchange chromatography, but it did not meet the criteria for percentage main peak by non-reduced CE-SDS, according to the investigators.¹

All similarity criteria for the primary mechanism of action, including known, likely, and plausible, were met by adalimumab-aqvh, with the exception of FcγRIIIa (an Fc gamma receptor) binding which was not met for 2 lots due to being slightly outside the similarity criteria.¹

The study authors said that “the totality of structural, functional, and stability data in this comparative analytical assessment supports a conclusion of biosimilarity between adalimumab-aqvh and the reference product.”¹

They concluded that adalimumab-aqvh is highly similar to adalimumab and the minor differences in physicochemical attributes did not affect functional activity. They said these differences should not influence the clinical efficacy or safety of the biosimilar. The study authors predict that similar efficacy and safety outcomes in any future clinical trials that compare the 2 drugs.¹

Reference

1. Jiang Y, Arora T, Klakamp S, et al. Demonstration of Physicochemical and Functional Similarity of Biosimilar Adalimumab-aqvh to Adalimumab. Drugs R D. 2023;23(4):377-395. doi:10.1007/s40268-023-00437-3
2. Coherus Announces U.S. FDA Approval of YUSIMRY (adalimumab-aqvh). News release. December 20, 2021. Accessed December 21, 2023. https://investors.coherus.com/news-releases/news-release-details/coherus-announces-us-fda-approval-yusimrytm-adalimumab-aqvh
3. Jeremias S. First Found of Adalimumab Biosimilar Launches in July. The Centers for Biosimilars. July 2, 2023. Accessed December 21, 2023. https://www.centerforbiosimilars.com/view/first-round-of-adalimumab-biosimilar-launches-in-july