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Biogen, Samsung Bioepis biosimilars as effective as branded therapies: analysis

Biogen Inc. and Samsung Bioepis Co. Ltd. said an analysis of results from three studies showed that their biosimilar medicines Benepali, Flixabi and Imraldi were as effective as their brand-name counterparts in patients with rheumatoid arthritis.

The phase 3 studies — the last of three stages of human testing usually required for regulatory approval — compared Benepali to etanercept, sold by Amgen Inc. as Enbrel; Flixabi to infliximab, sold by Johnson & Johnson as Remicade; and Imraldi to adalimumab, sold by AbbVie Inc. as Humira.

The branded biologics are among the world's best-selling medicines, with Humira alone bringing in more than $18 billion in 2017.

A biosimilar works in a similar way to an existing branded biologic, a type of treatment derived from living organisms. An anti-tumor necrosis factor, or TNF, biosimilar blocks the action of TNF, a protein that is overactive in patients with arthritis, to reduce the amount of inflammation being produced in your body.

Data from the Biogen-Samsung Bioepis studies were pooled together for the analysis. Researchers looked at changes in anti-drug antibodies, or proteins that are made as result of an immune response to therapy, through comparisons between the three anti-tumor necrosis factor biosimilars and their biologic counterparts. Developing anti-drug antibodies is linked to reduced effectiveness of the treatment and increased risk of reactions from infusion or injection of the medicines.

The analysis found that the occurrence of anti-drug antibodies in both the patients using biosimilars and those using branded biologics was comparable, suggesting that the biosimilars were as effective as the branded products.

In addition, researchers analyzed how well the biosimilars were tolerated by patients as well as radiographic progression by disease activity state, which reflects joint inflammation over time.

The studies showed that the therapies were safe and joint inflammation over time was minimal and comparable across all treatment groups.

The analysis will be presented at the European Congress of Rheumatology meeting in Amsterdam, which will be held June 13-16.