FDA Clears First Interchangeable Golimumab Biosimilars for RA and Ulcerative Colitis

Immgolis is administered by subcutaneous injection in a single-dose prefilled syringe and Immgolis Intri is administered as an intravenous infusion prepared from a single dose vial.

Immgolis is approved for the following treatment indications in adults, which are also currently approved for Simponi:

• patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate

• patients with moderately to severely active ulcerative colitis (UC)

Immgolis Intri is approved for the following treatment indications in adults, which are also currently approved for Simponi Aria:

• patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate

Golimumab products are human monoclonal antibodies that bind to a protein called tumor necrosis factor alpha (TNFα). By binding TNFα, golimumab products stop it from triggering inflammation which helps improve signs and symptoms of these diseases.

Disease or Condition

Rheumatoid Arthritis

Rheumatoid arthritis (RA) is an autoimmune and inflammatory disease, which means that your immune system attacks healthy cells in your body by mistake, causing inflammation (painful swelling) in the affected parts of the body. RA mainly attacks the joints and can affect many joints at once.

Ulcerative Colitis

Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) that affects the large intestine (colon) and rectum. It causes inflammation and ulcers in the lining of the colon, leading to various symptoms. The exact cause of UC is unknown, but it is believed to be an autoimmune disorder where your immune system mistakenly attacks the healthy cells in the colon. Other factors that may contribute to UC include genetics, environmental triggers, and infections.

Approval Information

A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by FDA (also called the reference product). This means patients can expect the same safety and effectiveness from the biosimilar as they would the reference product.

An interchangeable biosimilar is a biosimilar that has met other requirements under the law and may be substituted for the reference product without consulting the prescriber. The substitution may occur at the pharmacy, subject to state pharmacy laws which vary by state, a practice commonly called “pharmacy-level substitution” — similar to how generic drugs are substituted for brand name drugs.

All biological products are approved only after they meet FDA’s rigorous approval standards. This means health care providers and patients can expect the same safety and effectiveness from both a biosimilar and an interchangeable biosimilar, just as they would for a reference product. Biosimilar and interchangeable biosimilar products may cost less than the brand-name medicine (i.e., reference product).

FDA’s approval of Immgolis and Immgolis Intri is based on a comprehensive review of scientific evidence demonstrating the products are highly similar to Simponi and Simponi Aria, respectively, and that there are no clinically meaningful differences between the two product pairs. This evidence included comparisons of the products on an analytical level using an extensive battery of physicochemical tests and biological assays.

Multiple lots manufactured for each product were compared across a broad range of different product quality attributes, and the results of these comparisons confirmed similarity in the structural and functional features of Immgolis and Immgolis Intri with Simponi and Simponi Aria, including those known to impact safety and efficacy. A pharmacokinetic similarity study showed comparable exposure and immunogenicity results in subjects treated with Immgolis and subjects treated with Simponi. The totality of these data supported FDA approval of Immgolis as an interchangeable biosimilar to Simponi and Immgolis Intri as an interchangeable biosimilar to Simponi Aria.

Safety Information for Immgolis and Immgolis Intri

The expected side effects and adverse events for Immgolis and Immgolis Intri are consistent with those observed with Simponi and Simponi Aria.

The most common expected side effects of Immgolis/Immgolis Intri, like Simponi/Simponi Aria, are upper respiratory tract infection, nasopharyngitis, and injection site reactions (incidence > 5%).

Golimumab products can cause serious side effects including serious infections and malignancy (cancers). Patients treated with golimumab products are at increased risk for developing serious infections that may lead to hospitalization or death. See full prescribing information for additional information on risks associated with Immgolis and Immgolis Intri.

Designation

Immgolis and Immgolis Intri are the first interchangeable biosimilars approved for the reference products Simponi and Simponi Aria.