Drug makers Amgen and Allergan announced on Friday that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on ABP 215, the companies’ bevacizumab biosimilar. CHMP recommended the biosimilar for approval for the treatment of multiple cancer indications.
Drug makers Amgen and Allergan announced on Friday that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on ABP 215, the companies’ bevacizumab biosimilar. CHMP recommended the biosimilar for approval for the treatment of multiple cancer indications.
"ABP 215 has the potential to provide healthcare professionals and appropriate patients across Europe access to high-quality, targeted cancer therapy," said Sean E. Harper, M.D., executive vice president of research and development at Amgen. "The positive CHMP opinion for ABP 215 marks the first time a bevacizumab biosimilar has been recommended for approval in the European Union, which is an exciting milestone for Amgen."
Allergan’s chief research and development officers, David Nicholson, also praised the milestone along the biosimilar’s approval pathway, saying, "We are encouraged by the progress Amgen and Allergan have made in developing biosimilars in critical disease areas and look forward to providing important medicines to patients in the future."
The positive CHMP opinion will next be reviewed by the European Commission (EC), which holds the final authority to approve medicines in the European Union. If the EC approves the drug, Amgen and Allergan will be granted a centralized marketing authorization that will be valid in the 28 current EU member states. Norway, Iceland, and Liechtenstein, as members of the European Economic Area, will also undertake their own independent assessments of the biosimilar based on the EC’s decision.
ABP 215 was also approved by the FDA in September 2017, and will be sold in the United States under the brand name Mvasi once it reaches the US marketplace. However, when Mvasi may reach patients remains unclear; Amgen is currently involved in patent litigation with the reference bevacizumab’s (Avastin) manufacturer, Genentech. In October, Amgen filed suit against Genentech in a California district court, seeking a judgment that ABP 215 did not infringe, and will not infringe, on 27 patents covering Avastin.
BioRationality: Should mRNA Copies Be Filed as NDAs or Biosimilars?
November 4th 2024The article by Sarfaraz K. Niazi, PhD, argues that the FDA’s classification of future copies of messenger RNA (mRNA) products could be reconsidered, suggesting they might be eligible for new drug applications (NDAs) or a hybrid biosimilar category due to their unique characteristics and increasing prevalence.
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.
Panelists Stress Stakeholder Education to Build Confidence in Biosimilars
October 31st 2024By expanding educational initiatives to clarify biosimilar safety, efficacy, and interchangeability, stakeholders can foster trust, improve access, and ensure that biosimilars are widely accepted as high-quality, cost-effective alternatives to originator biologics.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
Strengthening the Supply Chain: Key Insights From FDA Commissioner Dr Robert Califf
October 25th 2024At the GRx+Biosims conference, FDA Commissioner Robert Califf, MD, stressed the urgent need for data transparency in the global supply chain and the role of collaboration and artificial intelligence in ensuring the resilience of biosimilar and generic drug production.