Kennedy Ferruggia is an Assistant Editor for Pharmacy Times

Kennedy Ferruggia

This article was originally published by 

The FDA has approved Immgolis (golimumab-sldi; Bio-Thera Solutions) and Immgolis Intri (golimumab-sldi; Bio-Thera Solutions) as interchangeable biosimilar biological products to Simponi (subcutaneous golimumab; Janssen Biotech) and Simponi Aria (intravenous [IV] golimumab; Janssen Biotech), respectively. These approvals mark a significant milestone in the treatment landscape for patients with several chronic autoimmune conditions.

FDA approval clears interchangeable golimumab biosimilars for rheumatoid arthritis and ulcerative colitis, promising lower-cost TNF therapy. | Image credit: Janssen Biotech - stock.adobe.com

Immgolis and Immgolis Intri are the first biosimilars to their respective golimumab reference products. Immgolis was approved for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) in combination with methotrexate and for adults with moderately to severely active ulcerative colitis (UC). Immgolis Intri was approved for the treatment of adults with moderate to severe active RA in combination with methotrexate.

Immgolis is administered as a subcutaneous injection in a single-dose prefilled syringe; Immgolis Intri is prepared from a single-dose vial and administered as an IV infusion. Both products were developed and manufactured by Bio-Thera Solutions, a commercial-stage biopharmaceutical company based in Guangzhou, China.

"Bio-Thera is proud to have developed the first approved biosimilar of golimumab in the United States of America,” Shengfeng Li, PhD, CEO of Bio-Thera, said in a news release. "We are excited to support Accord BioPharma's commercialization efforts to bring [Immgolis] and [Immgolis Intri] to patients in need of an affordable biosimilar of golimumab who are living with the chronic, debilitating autoimmune conditions associated with moderately to severely active RA or UC."

Golimumab is a human IgG1 monoclonal antibody that targets tumor necrosis factor alpha (TNF-α), a key proinflammatory mediator. By binding to TNF-α, golimumab reduces levels of several downstream inflammatory markers, including C-reactive protein, IL-6, ICAM-1, matrix metalloproteinase-3, and VEGF.

Clinical Evidence Supporting Biosimilarity

The FDA's approval was based on a comprehensive analytical, nonclinical, and clinical data package. Extensive analytical characterization of Immgolis and Immgolis Intri was conducted across structural, physicochemical, and biological properties. A randomized, double-blind, single-dose, 3-arm, parallel phase 1 study (NCT05332730) compared the pharmacokinetics, safety, and immunogenicity of Immgolis with both US and EU reference golimumab formulations in healthy volunteers. Additionally, a multicenter, randomized, double-blind, parallel-arm phase 3 study (NCT05046431) compared Immgolis with the reference golimumab product for efficacy, safety, and immunogenicity in patients with active psoriatic arthritis.

The FDA stated that the totality of evidence demonstrated no meaningful clinical differences between the biosimilars and the reference products, including comparable exposure and immunogenicity results in a human pharmacokinetic similarity study.

The adverse event (AE) profile observed with Immgolis and Immgolis Intri is consistent with that of the reference golimumab products. The most commonly reported AEs, which occurred in fewer than 5% of patients, include upper respiratory tract infection, nasopharyngitis, and injection site reactions. Serious potential AEs include malignancies and serious infections that could require hospitalization. Notably, where permitted by state law, pharmacies may dispense Immgolis and Immgolis Intri in place of the reference golimumab products, as both biosimilars have been designated interchangeable by the FDA.

Clinicians and pharmacists should be aware of the current approved labeling limitations. Immgolis is not indicated for active psoriatic arthritis or active ankylosing spondylitis in adults, nor for pediatric patients weighing at least 15 kg with moderately to severely active UC. Similarly, Immgolis Intri is not indicated for active psoriatic arthritis, active ankylosing spondylitis, or active polyarticular juvenile idiopathic arthritis. These limitations stem from ongoing patent litigation between Janssen Biotech and Bio-Thera Solutions related to those specific indications.

Industry Context and Patient Access Implications

The approvals arrive as the golimumab market enters a new competitive era. Johnson & Johnson reported US sales of approximately $1.08 billion for its golimumab products in 2024, and the reference golimumab products had previously faced no approved biosimilar competition in the US. With Immgolis and Immgolis Intri offering comparable safety and efficacy at potentially lower costs, these approvals are expected to meaningfully expand access for patients with RA and UC, which are conditions associated with substantial disease burden and long-term treatment costs. Pharmacists are well-positioned to counsel patients and providers on the interchangeability of these products and support transitions where appropriate.

1. Bio-Thera Solutions' golimumab biosimilars receive FDA approval as first biosimilars to Simponi and Simponi Aria. News release. Bio-Thera Solutions. May 18, 2026. Accessed May 18, 2026. 

https://www.prnewswire.com/news-releases/bio-thera-solutions-golimumab-biosimilars-receive-fda-approval-as-first-biosimilars-to-simponi-and-simponi-aria-accord-biopharma-to-commercialize-immgolis-golimumab-sldi-and-immgolis-intri-golimumab-sldi-in-the-united-st-302774570.html

2. FDA approves first interchangeable biosimilars to Simponi and Simponi Aria (golimumab) to treat rheumatoid arthritis and ulcerative colitis. News release. FDA. Updated May 15, 2026. Accessed May 18, 2026. 

https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-interchangeable-biosimilars-simponi-and-simponi-aria-golimumab-treat-rheumatoid

Articles

FDA approval clears interchangeable golimumab biosimilars for rheumatoid arthritis and ulcerative colitis, promising lower-cost TNF therapy.

FDA Approves Immgolis and Immgolis Intri as First Biosimilars to Golimumab Reference Products for RA and UC

This article was originally published on Pharmacy Times

Biosimilars play a crucial role in increasing access to lifesaving medications at potentially lower costs. According to the FDA, biosimilars are safe and effective, providing treatment for various illnesses, including chronic skin and bowel diseases, arthritis, kidney conditions, and cancer.

Adalimumab (Humira; AbbVie) is one of the leading products in the biologics market, often used to treat immune and inflammatory conditions. Unlike other biosimilars, adalimumab biosimilars have unique interchangeability and concentration considerations that impact pharmacy practices. Understanding the availability and considerations surrounding these products is essential—emphasizing the pharmacists’ role in educating patients on their use and workflow.

As a biological medicine, adalimumab is made from proteins or other substances produced by the body. It is used to reduce inflammation by acting on the immune system, treating swelling caused by rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, and uveitis.

 The injectable treats these autoimmune conditions in adults and children by blocking the tumor necrosis factor (TNF) protein, which is a known cause of inflammation in the body.

Adalimumab was first approved by the FDA in December 2002 and is available in several different doses, ranging from 10 mg to 80 mg.

 Since its initial approval, 10 adalimumab biosimilars have been approved in the US. However, adalimumab biosimilars differ from adalimumab in approved indications, concentration and dosage, and formulation.

 was the first FDA-approved adalimumab biosimilar in September 2016. Following its initial approval, adalimumab-atto became the first to launch in the US on January 31, 2023, indicated to treat adults with hidradenitis suppurativa (HS) and uveitis. It is available in a 40 mg and 80 mg prefilled autoinjector pen and in 10 mg, 20 mg, 40 mg, and 80 mg prefilled syringes.

Adalimumab-adbm (Cyltezo; Boehringer Ingelheim)

 received FDA approval in August 2017 and became the first interchangeable biosimilar with adalimumab. Adalimumab-adbm launched on July 1, 2023, to treat HV and uveitis. Availability includes a 40 mg prefilled pen and a 10 mg, 20 mg, and 40 mg syringe.

Adalimumab-adaz (Hyrimoz; Sandoz Pharmaceuticals)

 received FDA approval in October 2018 for the treatment of HS in adults. The injection pens are available at 40 mg for the low-concentration formulation and 40 mg and 80 mg for the high-concentration version. The prefilled syringes are available in 10 mg, 20 mg, and 40 mg (low concentration); 10 mg, 20 mg, 40 mg, and 80 mg (high concentration).

Adalimumab-bwwd (Hadlima; Samsung Bioepis)

 was approved by the FDA in July 2019 and launched in the US on July 1, 2023, for treatment of HS and uveitis. The autoinjector and syringe are available in a 40 mg dose—both low- and high-concentration.

 received FDA approval in November 2019, marked as the second interchangeable adalimumab biosimilar. It officially launched in November 2023 and is available in a 40 mg prefilled pen and a 10 mg, 20 mg, and 40 mg syringe.

Adalimumab-fkjp (Hulio; Viatris, Fujifilm Kyowa Kirin Biologics)

 was approved in July 2020 and launched in July 2023, also for the treatment of HS and uveitis with similar dosing indications as adalimumab-bwwd.

Adalimumab-aqvh (Yusimry; Coherus BioSciences)

 was launched in July 2023 but received FDA approval in December 2021. It is only available in a low-concentration and citrate-free 40 mg prefilled pen and syringe.

 was the third to launch in July 2023, following its approval in December 2022; it is only available in a 40 mg prefilled pen and syringe.

 was granted approval in May 2023 and was the last to launch in July 2023. It is available in 20 mg, 40 mg, and 80 mg prefilled syringes and 40 mg and 80 mg autoinjectors.

Adalimumab-ryvk (Simlandi; Alvotech, Teva Pharmaceuticals)

 is the tenth biosimilar to receive FDA approval in February 2024; it is also indicated for HS and uveitis and is available in a 40 mg injector.

Pharmacists play a primary role in the landscape of adalimumab biosimilars, as many are indicated for similar treatment and are available in comparable doses, requiring a treatment expert to stay abreast of dosage and treatment requirements for each patient. Ensuring proper selection, dispensing, and monitoring of these biosimilars are crucial for patient outcomes. As the biosimilars landscape continues to evolve, pharmacists can educate health care providers and patients on the availability and benefits of adalimumab biosimilars while addressing concerns about their safety and efficacy.

1. Biosimilars. FDA. News release. Updated March 3, 2023. Accessed March 5, 2025. 

https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars

2. Preparing for the market entry of adalimumab biosimilars in the US in 2023: A primer for specialty pharmacists. News release. American Journal of Health-System Pharmacy; Published May 31, 2023. Accessed March 5, 2025. 

https://academic.oup.com/ajhp/article-abstract/80/18/1223/7187391?redirectedFrom=fulltext&login=false

3. About adalimumab. NHS. News release. Updated March 24, 2022. Accessed March 5, 2025. 

https://www.nhs.uk/medicines/adalimumab/about-adalimumab/

4. Is there a biosimilar for Humira? Yes, here are 10 Humira biosimilars to choose from. News release. GoodRx; Updated May 14, 2024. Accessed March 5, 2025. 

https://www.goodrx.com/humira/biosimilars

5. Humira FDA approval history. News release; Drugs.com.  Updated August 25, 2022. Accessed March 5, 2025.

 https://www.drugs.com/history/humira.html

6. Biosimilar medicines uptake: the role of the clinical pharmacist. Exploratory Research in Clinical and Social Pharmacy. Published March 2021. Accessed March 5, 2025. 

https://www.sciencedirect.com/science/article/pii/S2667276621000081?via%3Dihub

Adalimumab biosimilars differ from adalimumab in approved indications, concentration and dosage, and formulation.

Kennedy Ferruggia

FDA Approves Immgolis and Immgolis Intri as First Biosimilars to Golimumab Reference Products for RA and UC

Pharmacists Play a Crucial Role in Adalimumab Biosimilars for Patient Care