- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
European Commission Authorizes Pfizer's Bevacizumab Biosimilar, Zirabev
Pfizer received authorization from the European Commission for its bevacizumab biosimilar, PF-06439535, to be sold under the trade name Zirabev for the treatment of certain advanced cancers: carcinoma of the colon or rectum, breast cancer, non–small cell lung cancer (NSCLC), renal cell cancer, and cervical cancer.
Pfizer announced today that it has received final approval from the European Commission for its bevacizumab biosimilar, PF-06439535, to be sold under the trade name Zirabev for the treatment of certain advanced cancers: carcinoma of the colon or rectum, breast cancer, non—small cell lung cancer (NSCLC), renal cell cancer, and cervical cancer.
Bevacizumab is the company’s fifth biosimilar approved in Europe.
“Pfizer is dedicated to increasing access to biosimilars for patients suffering from serious illnesses and helping create a more sustainable healthcare system,” Andreas Penk, MD, regional president of oncology international developed markets, said in a statement. “We are proud that ZIRABEV was approved today as our second oncology biosimilar in Europe. This milestone reflects our ongoing commitment to biosimilars as we continue to bring high-quality medicines to market that may help generate cost savings for cancer care.”
In December 2018, the company recieve a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). The positive opinion was based on a data package that included results from the phase 3 REFLECTIONS B739-03 clinical comparative study that showed the clinical equivalence of Zirabev with the reference bevacizumab in patients with nonsquamous NSCLC. According to Pfizer, as part of the overall REFLECTIONS clinical program, the proposed biosimilar has been studied in approximately 400 individuals.
The EC decision is good for a centralized marketing authorization that will be valid in all 28 EU member states. Norway, Iceland, and Liechtenstein, members of the European Economic Area, will follow corresponding decisions based on the EC’s decision.
Pfizer has also filed for approval for the drug from the FDA.
Also approved in Europe is Amgen’s bevacizumab biosimilar, Mvasi, which was granted EC authorization in January 2018. Mvasi is also approved by the FDA, but the drug has not yet launched in either territory.
Review Calls for Path to Global Harmonization of Biosimilar Development Regulations
March 17th 2025Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite challenges posed by differing national requirements and regulatory frameworks, according to review authors.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
From Amjevita to Zarxio: A Decade of US Biosimilar Approvals
March 6th 2025Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 originators—though the journey has been anything but smooth, with adoption facing hurdles along the way.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Biosimilar Approvals Streamlined With Advanced Statistics Amidst Differing Regulatory Requirements
February 25th 2025The FDA and European Medicines Agency (EMA) mandate high similarity between biosimilars and reference products, but their regulatory processes differ, especially with multiple reference products.
