In a busy beginning of the week, the US Food and Drug Administration approved new biosimilars for Humira®and Rituxan®. Samsung Bioepis gained approval for Hadlima™ (adalimumab-bwwd), and Pfizer scored with Ruxience™ (rituximab-pvvr).
The approval for Hadlima covers the following indications:
- Rheumatoid arthritis
- Juvenile idiopathic arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn’s disease in adults
- Ulcerative colitis
- Plaque psoriasis
Formerly known as SB5, Samsung Bioepis secured Hadlima’s approval on the basis of phase 1 and phase 3 studies in rheumatoid arthritis. The phase 3 investigation included over 500 patients, finding ACR20 responses to be equivalent to that of Humira (at 72%). Immunogenicity profiles for the two agents were also similar through 52 weeks of a switching study.
According to its licensing agreement with Abbvie, manufacturer of Humira, Samsung will not be able to market this agent until end of June 2023. This agent joins Samsung’s two other approved anti-TNF biosimilars, Renflexis (infliximab) and Eticovo (etanercept). Only Renflexis is currently marketed in the US.
Pfizer’s newest biosimilar entry, Ruxience, has been approved for a subset of indications of reference product Rituxan, including:
- Treatment of adult patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin’s lymphoma who are CD20-positive and have failed prior treatments
- Patients who have nonprogressing, low-grade, CD20-positive B-cell non-Hodgkin’s lymphoma and who are stable after receiving a prior chemotherapy regimen containing cyclophosphamide, vincristine and prednisone
- Patients with CD20-positive follicular lymphoma who are therapy naïve in combination with chemotherapy or who had responded to previous rituximab therapy
- Patients with CD20-positive chronic lymphocytic leukemia in combination with fludarabine and cyclophosphamide
- Granulomatosis with polyangiitis in adult patients in combination with glucocorticoids
The biosimilar does not include Rituxan’s labeled indication for rheumatoid arthritis, similar to the other approved rituximab biosimilar.
The application for Ruxience included the results of the phase 3 clinical trial (REFLECTIONS), which included 394 patients with follicular lymphoma. Compared with the EU-licensed version of rituximab (MabThera®), Ruxience was found to provide equivalent clinical and safety outcomes.
Originally designated PF-05280586, Pfizer has not disclosed when Ruxience will be available. Pfizer signed a settlement with Roche (Genentech) over litigation for a key Rituxan patent, but terms of this agreement were not disclosed. The other FDA-approved biosimilar competitor in this space, Celltrion’s Truxima®, is similarly awaiting launch.