Pfizer's Biosimilar RUXIENCE (Rituximab) Set for EU Approval in H1, Already Launched in the U.S.

Feb 08, 2020 16:05 CST Updated 16:05

Pfizer

Pharmaceutical R&D Developer

Committee for Medicinal Products for Human Use

Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.

Roche

Oncology Drug Research, Development, and Manufacturing

February 08, 2020 /BIOON/ -- Pfizer recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of Ruxience (rituximab), a biosimilar to Roche’s branded drug MabThera (generic name: rituximab). Ruxience is a monoclonal antibody indicated for the treatment of: non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), and pemphigus vulgaris (PV).

The CHMP’s opinion will now be submitted to the European Commission (EC) for review, with a final approval decision expected in the first half of 2020. In the United States, Ruxience was approved by the FDA in July 2019 for the treatment of adult patients with NHL, CLL, GPA, and MPA. Ruxience has recently been launched on the U.S. market.

The regulatory submission for Ruxience in the European Union was supported by a comprehensive data package demonstrating its similarity to the reference product. This included results from the REFLECTIONS B3281006 clinical comparative study, conducted in patients with CD20-positive, low-tumor-burden follicular lymphoma (FL), which evaluated the efficacy, safety, immunogenicity, pharmacokinetics, and pharmacodynamics of Ruxience. The study found no clinically meaningful differences in safety or efficacy compared to the control product.

Chris Boshoff, M.D., Chief Development Officer of Oncology in Pfizer’s Global Product Development organization, stated, “Biosimilars such as Ruxience can play a significant role in cancer treatment, helping to expand patient access to potentially life-changing therapies. We are committed to bringing biosimilars like Ruxience to market as a treatment option, offering safety and efficacy comparable to the reference product at a potentially lower cost. If approved, Ruxience will become the fifth oncology biosimilar to receive regulatory approval for Pfizer in Europe.”

Over the past decade, biosimilars have served as a key catalyst for transformation in the global healthcare industry, contributing to the establishment of a more sustainable healthcare system. With over 10 years of experience in the global biosimilars market and five approved biosimilar products in Europe, Pfizer is proud to be a leader and frontrunner in this critical area of healthcare. (Bioon.com)

Original Source: Pfizer Receives Positive CHMP Opinion for Oncology Biosimilar, RUXIENCE® (rituximab)