FDA approves first interchangeable Simponi biosimilars

Edited by Robert McTiernan··2 min read

The US FDA has approved Immgolis and Immgolis Intri (golimumab-sldi) as the first interchangeable biosimilars to Johnson & Johnson’s Simponi and Simponi Aria (golimumab), respectively, marking a regulatory milestone for the anti-TNF class in rheumatology and gastroenterology. The approvals were granted to Accord BioPharma, the US subsidiary of Intas Pharmaceuticals, under a licensing agreement with Bio-Thera Solutions, which developed and manufactures the biosimilar molecule, designated BAT2506.

Immgolis is approved for adults with moderately to severely active rheumatoid arthritis in combination with methotrexate, and for moderately to severely active ulcerative colitis. Immgolis Intri carries approval for the rheumatoid arthritis indication only. Immgolis is administered by subcutaneous injection via a prefilled syringe, while Immgolis Intri is delivered as an intravenous infusion prepared from a single-dose vial, mirroring the administration formats of the respective reference products.

Golimumab is a fully human monoclonal antibody that binds tumor necrosis factor alpha, preventing it from triggering downstream inflammatory signaling. The mechanism is well established across the TNF inhibitor class, and golimumab-sldi was reviewed as biosimilar to reference golimumab on the basis of analytical, functional, and pharmacokinetic comparability rather than independent clinical efficacy trials.

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The FDA’s approval rested on a comprehensive comparability package rather than a standalone randomized trial, with the totality of evidence supporting both biosimilarity and the additional interchangeability designation. The interchangeability designation means a biosimilar may be substituted for the reference product at the pharmacy level without requiring prescriber consultation, a process analogous to generic substitution for small-molecule drugs.

Johnson & Johnson secured approvals for Simponi and Simponi Aria in 2009 and 2013, respectively. In the broader rheumatoid arthritis market, adalimumab and its biosimilars — including products such as Yuflyma (adalimumab-aaty) and Simlandi (adalimumab-ryvk) — represent the most commercially active TNF inhibitor biosimilar class currently operating in the US, having entered following the expiry of AbbVie’s exclusivity on Humira (adalimumab). Immgolis and Immgolis Intri enter a market where payer and pharmacy substitution dynamics are already being shaped by that earlier wave of adalimumab biosimilar competition.

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