The study was designed to elucidate incidence of hypertension and proteinuria in patients treated with bevacizumab reference vs biosimilar products.
Results were inconclusive in a study of hypertension and proteinuria in 75 patients treated with bevacizumab reference vs biosimilar products, investigators reported at the ASCO Gastrointestinal Cancers Symposium 2021.
They compared incidence of hypertension and proteinuria in patients treated with various chemotherapy regimens in combination with bevacizumab. Investigators evaluated reference bevacizumab (Avastin) vs 2 biosimilars introduced on the US market starting in 2019: Mvasi, first marketed in July 2019, and Zirabev, first marketed in January 2020. The study period extended from January 2019 to July 2020 and enrolled patients with gastrointestinal cancer at Roswell Park Comprehensive Cancer Center at Buffalo, New York.
“Early recognition of uncontrolled blood pressures and worsening kidney function is needed to prevent delayed intervention,” investigators said, recommending routine monitoring of hypertension and proteinuria following treatment with bevacizumab.
Bevacizumab is a recombinant humanized monoclonal antibody that targets the development of blood vessels that support the growth of tumors. Hypertension and proteinuria, which can lead to pulmonary edema and affects kidney health, are adverse events of bevacizumab.
Investigators noted a higher risk of hypertension in the reference bevacizumab group (52.4% vs 36.4%), although this was not statistically significant (P = .2427). They observed hypertension in patients after a median of 5 doses of reference bevacizumab vs 1.5 doses of bevacizumab biosimilar (P = .0005).
Investigators observed a higher risk of proteinuria for patients treated with reference bevacizumab vs bevacizumab biosimilar (35.7% vs 30%), although this difference was not statistically significant (P = .7193). However, proteinuria occurred later in the treatment cycle with reference bevacizumab than with bevacizumab biosimilar (median, 213 days vs 53.5 days following the first bevacizumab dose; P = .0022).
Investigators concluded that the incidence of hypertension and proteinuria in patients treated with reference vs biosimilar bevacizumab requires study in larger patient cohorts.
Reference
Man Y, Yu H, Mukerjee S, Zalewski O. Incidence of hypertension and proteinuria in patients treated with bevacizumab versus bevacizumab biosimilar. Presented at ASCO GI Cancers Symposium 2021; January 15-17, 2021. Accessed January 19, 2021. https://meetinglibrary.asco.org/record/194106/abstract
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Addressing Patent Abuse, Reimbursement Models Key to Sustainable Biosimilar Market
April 25th 2025Sonia T. Oskouei, PharmD, emphasized strategies to streamline regulations and evolve to overcome barriers and expand the availability of cost-effective biosimilar treatments across more therapeutic areas.
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.
Decade of Biosimilars Yields $36 Billion in Savings and Strengthens Supply Chain
April 24th 2025Dracey Poore, MS, director of biosimilars and emerging therapies at Cardinal Health, highlighted that biosimilars saved $36 billion over the last decade by improving patient access and the supply chain, but continued education and a robust pipeline are crucial for future growth.