FDA Approves Abrilada, Biosimilar to Humira, for Adults with Ankylosing Spondylitis and Other Disorders

Abrilada (adalimumab-afzb), a biosimilar to Humira (adalimumab), has been approved by the U.S. Food and Drug Administration (FDA) to treat people with seven inflammatory diseases, including adults with ankylosing spondylitis.

Pfizer, the company that developed Abrilada, expects the therapy to be available in the U.S. starting in 2023.

“Biosimilars like Abrilada represent an opportunity to help improve access to important treatment options for patients living with chronic, and often debilitating, inflammatory conditions,” Richard Blackburn, global president of inflammation and immunology at Pfizer, said in a press release.

Biologic therapies are made from living organisms and include vaccines, cell therapies, or — in the case of AbbVie’s Humira — from antibodies. Unlike conventional treatments, which are chemically synthesized and have a well-known structure, biologics are more complex and variable, so generic versions are not possible.

Biosimilars are nearly identical to reference biologic medications, but are manufactured by a different company after the original patent expires. Such therapies may have lower costs, depending on country and the patient’s insurance coverage.

Adalimumab, the active agent of both Abrilada and Humira, is an antibody that blocks TNF (tumor necrosis factor), an inflammatory molecule that plays a critical role in ankylosing spondylitis and other disorders.

Current TNF inhibitors in the U.S. also include infliximab (marketed as Remicade, Remsima, and Inflectra), Enbrel (etanercept), Cimzia (certolizumab), and Simponi (golimumab).

In line with its standard practice for biosimilars, the FDA approved Abrilada based on evidence of its similar efficacy, safety, and immunogenicity — the propensity to trigger an immune response — to Humira, which was first approved in the U.S. in 2002. These similarities are key for biologic therapies, as their effects are more difficult to replicate than those of pharmacological medicines.

Such evidence was provided by data from the Phase 3 Reflections B538-02 clinical trial (NCT02480153), among other studies. This trial involved 597 people with moderate-to-severe rheumatoid arthritis, randomly assigned to treatment with either Abrilada or Humira, both given in combination with the anti-rheumatic treatment methotrexate.

“Our current portfolio of approved biosimilar products is one of the broadest in the industry and we are proud to offer additional treatment options for patients,” added Blackburn.

Like Humira, Abrilada is approved to treat the signs and symptoms of active ankylosing spondylitis in adults.

The FDA’s approval also covers adults with rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, and two forms of inflammatory bowel disease: Crohn’s disease and ulcerative colitis. In juvenile idiopathic arthritis, the therapy is for use by patients age 4 and older.