- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
European Medicines Agency Authorizes Marketing of Pfizer's Ruxience
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended marketing authorization for Pfizer's Ruxience, a rituximab biosimilar.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) Friday recommended marketing authorization for Pfizer's Ruxience, its rituximab biosimilar.
The opinion of the CHMP will be reviewed by the European Commission, and a regulatory decision could be announced in the next 6 months. If approved, Ruxience will be Pfizer’s fifth regulated oncology biosimilar in Europe. Ruxience was approved by the FDA in July of 2019 and launched January last in the United States.
The originator rituximab is sold as Rituxan in the United States and and as MabThera in Europe and other regulatory territories.
According to the CHMP, Ruxience will be available as 100- and 500-mg concentrates for solution for infusion. Rituximab is used in conditions such as non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, and pemphigus vulgaris, according to a press release.
The chief development officer of oncology at Pfizer Global Product and Development, Chris Boshoff, MD, PhD, said of the authorization, “Biosimilars like Ruxience can play an important role in cancer care, helping to expand patient access to potentially life-changing therapies. We are committed to bringing biosimilars like Ruxience to the market as a treatment option with similar safety and efficacy to the originator product at a potentially lower cost.”
The regulatory submission is supplemented by results form a clinical comparative study, which “found no clinically meaningful differences in safety or efficacy compared to the reference product in patients with CD20-positive, low tumor burden follicular lymphoma,” according to the company.
Pfizer recently announced it expects its 3 oncology biosimilar products to have the lowest wholesale acquisition cost (WAC) among currently available bevacizumab, rituximab, or trastuzumab biosimilars in the United States. Ruxience has a WAC of $71.68 per 10 mg, which is a 24% discount to the WAC of rituxan.
Health Canada Approves First Omalizumab Biosimilar
December 16th 2024Health Canada has approved Omlyclo, the first omalizumab biosimilar in Canada, for the treatment of chronic idiopathic urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps, based on a phase 3 study confirming its bioequivalence to the reference product.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Commercial Payer Coverage of Biosimilars: Market Share, Pricing, and Policy Shifts
December 4th 2024Researchers observe significant shifts in payer preferences for originator vs biosimilar products from 2017 to 2022, revealing growing payer interest in multiple product options, alongside the increasing market share of biosimilars, which contributed to notable reductions in both average sales prices and wholesale acquisition costs.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
The Rebate War: How Originator Companies Are Fighting Back Against Biosimilars
November 25th 2024Few biologics in the US have multiple biosimilar competitors, but originator biologics respond quickly to competition by increasing rebates and lowering net prices, despite short approval-to-launch timelines for biosimilars.
