Pfizer's Biosimilar Adalimumab Receives Positive CHMP Opinion
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Pfizer’s biosimilar adalimumab referencing Humira. The product, which Pfizer proposes to market under the name Amsparity, will now be reviewed by the European Commission before it receives final marketing authorization.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Pfizer’s biosimilar adalimumab referencing Humira. The product, which Pfizer proposes to market under the name Amsparity, will now be reviewed by the European Commission before it receives final marketing authorization.
If authorized, the biosimilar will be available for injection in a 40-mg prefilled syringe and prefilled pen, and will carry indications for rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, hidradenitis suppurativa (HS), Crohn disease in adults and children, ulcerative colitis, and uveitis in adults and children.
For pediatric uses only, the biosimilar will also be available in a 20-mg prefilled syringe and in a 40 mg/0.8 ml vial.
If authorized in Europe, the product will join fellow authorized adalimumab biosimilars Cyltezo, Hulio, Hyrimoz, Imraldi, and Idacio (also authorized as Kromeya), and under the terms of a 2018 patent settlement with AbbVie, maker of the reference Humira, Pfizer will be free to launch the drug in the EU market immediately upon authorization.
The biosimilar recently gained FDA approval as well, and the product will be marketed in the United States as Abrilada. Under Pfizer’s settlement with AbbVie, the product will not launch in the US market until November 20, 2023. While the terms of the deal were confidential, Pfizer acknowledged that it will pay royalties to AbbVie on sales of the biosimilar product.
Approval by the FDA was based in part on results of a 78-week, double-blind, multicenter, randomized study comparing the proposed biosimilar with EU-licensed Humira in 597 biologic-naïve patients with rheumatoid arthritis, from which 26-week results of the study have been published.1
The study’s primary end point was the proportion of patients reaching the American College of Rheumatology’s criteria for 20% improvement (ACR20) at week 12. The 26-week period of initial treatment was completed by 286 patients in the biosimilar arm and 273 patients in the reference arm. In the biosimilar arm, 68.7% of patients achieved ACR20, as did 72.7% of patients in the reference arm; the treatment difference was −3.98%, which was contained within the prespecified equivalence margin of ±14%. ACR20, 50, and 70 rates were also similar through week 26 for both groups.
Reference
1. Fleischmann RM, Alten R, Pileckyte M, et al. A comparative clinical study of PF-06410293, a candidate adalimumab biosimilar, and adalimumab reference product (Humira) in the treatment of active rheumatoid arthritis. Arthritis Res Ther. 2018;20(1):178. doi: 10.1186/s13075-018-1676-y.
