The Food and Drug Administration (FDA) has approved Abrilada (adalimumab-afzb; Pfizer), a biosimilar to Humira (adalimumab; AbbVie).
Abrilada, a tumor necrosis factor (TNF) blocker, is indicated for:
- Rheumatoid arthritis (RA): reducing signs/symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA; may be used alone or with methotrexate (MTX) or non-biologic DMARDs.
- Juvenile idiopathic arthritis (JIA): reducing signs/symptoms of moderately to severely active polyarticular JIA in patients ≥4 years old; may be used alone or with MTX.
- Psoriatic arthritis (PsA): reducing signs/symptoms, inhibiting the progression of structural damage, and improving physical function in patients with active PsA; may be used alone or with non-biologic DMARDs.
- Ankylosing spondylitis (AS): reducing signs/symptoms in patients with active AS.
- Adult Crohn disease (CD): reducing signs/symptoms, inducing and maintaining clinical remission for moderately to severely active CD in patients with inadequate response to conventional therapy; reducing signs/symptoms, inducing clinical remission in patients who have also lost response to or are intolerant to infliximab.
- Ulcerative colitis (UC): inducing and sustaining clinical remission for moderately to severely active UC in adult patients with inadequate response to immunosuppressants (corticosteroids, azathioprine, or 6-MP).
- Plaque psoriasis (PsO): treating adult patients with moderate to severe chronic PsO who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
The approval of Abrilada was based on data demonstrating that it is highly similar to an FDA-approved biological product, and that there are no clinically meaningful differences between the biosimilar and the reference product. In addition, results from the REFLECTIONS B538-02 study, which assessed the efficacy, safety, and immunogenicity of Abrilada vs adalimumab, showed that the biosimilar was equivalent to the reference product in patients with moderately to severely active RA on background MTX. At Week 12, the ACR20 response rate (primary end point) was 68.7% for patients treated with Abrilada compared with 72.7% for adalimumab (treatment difference: -2.98%; 95% CI: -10.38%, 4.44%).
Pfizer plans to make Abrilada available in the US in 2023. It is expected to be supplied as a 40mg/0.8mL solution in single-dose pens, prefilled syringes and vials, as well as a 10mg/0.2mL and 20mg/0.4mL solution in single-dose prefilled syringes.
For more information visit pfizer.com.