Golimumab biosimilars

Fully human IgG1 kappa monoclonal antibody of about 150 kDa, produced in a murine hybridoma cell line from transgenic mice carrying human immunoglobulin genes.

Binds soluble and transmembrane tumour necrosis factor alpha with high affinity and prevents it from engaging TNF receptors, the same mechanism as adalimumab and infliximab; its distinguishing feature is a longer dosing interval.

Subcutaneous bioavailability about 51%, peak concentrations at two to six days and a half-life of about two weeks, allowing once-monthly injection. Methotrexate lowers clearance and antibody formation. The intravenous presentation, given every eight weeks after induction, is a separate BLA in the United States.

50 mg subcutaneously once a month for arthritis and spondyloarthritis (100 mg for patients over 100 kg); 200 mg then 100 mg induction and 100 mg every four weeks in ulcerative colitis, as 50 mg/0.5 mL and 100 mg/mL pre-filled syringes and pens; 2 mg/kg intravenously every eight weeks (Simponi Aria).

• Rheumatoid arthritis with methotrexate
• Psoriatic arthritis
• Ankylosing spondylitis and non-radiographic axial spondyloarthritis
• Ulcerative colitis
• Polyarticular juvenile idiopathic arthritis

Anti-golimumab antibodies develop in a small proportion of patients, more often without methotrexate, and are associated with lower concentrations. Comparative programmes use analytical similarity, a pharmacokinetic study in healthy volunteers and a comparative efficacy study in rheumatoid arthritis with DAS28 or ACR20 at week 24, with extrapolation to the other indications.

Simponi was licensed by FDA on 24 April 2009 (BLA 125289) and authorised in the EU on 1 October 2009 (EMEA/H/C/000992), with the intravenous Simponi Aria added in the US in 2013. Alvotech's AVT05 became the first golimumab biosimilar as Gobivaz (Advanz) in November 2025 and Gotenfia (Stada) in February 2026 in the EU, and Accord's Immgolis, with an intravenous presentation, was the first US approval in May 2026, interchangeable on licensure. Reliance Life Sciences received an Indian manufacturing permission in April 2023.

Sources: Purple Book (S016), EMA medicines data (S017), CDSCO lists (S011, S013).

Golimumab is the last of the four major anti-TNF antibodies to attract biosimilars, and the newest market in this register: nothing before November 2025 anywhere outside India. It is a smaller molecule commercially than adalimumab, so the field is narrower, which is exactly what makes it interesting for a second-wave developer, and India's Reliance was first with a permission two and a half years before the EU.