Multiple drug makers are in the process of developing biosimilar candidates to challenge the brand-name Erbitux’s sales.
Cetuximab (Erbitux), an anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody used to treat metastatic colorectal cancer, metastatic non—small cell lung cancer, and head and neck cancer, was approved by the FDA in 2004, and US patents for the drug expired in 2016 (EU patents expired in 2014). In 2015, Bristol-Myers Squibb transferred North American marketing rights of biosimilar cetuximab to collaborator Eli Lilly. However, despite reported 2016 sales of $1.7 billion, the originator cetuximab has no approved biosimilar challengers in the US or European market.
Multiple drug makers, however, are in the process of developing biosimilar candidates to challenge the brand-name Erbitux’s sales:
As developers work toward biosimilars of this drug, the reference product sponsor is well on its way to expanding indications for the innovator product; in 2012, the FDA granted approval to cetuximab for use in combination with folinic acid, fluorouracil, and irinotecan (FOLFIRI chemotherapy) for first-line treatment of patients with K-ras mutation-negative (wild-type) EGFR-expressing metastatic colorectal cancer.
Additionally, currently ongoing is a phase 2 trial to investigate the combined usage of afatinib (Gilotrif) in patients with an EGFR-mutated lung cancer. Afatinib is an irreversible EGFR tyrosine kinase Inhibitor (TKI) that binds to its receptor permanently. Unlike other EGFRs, afatinib inhibits the kinase activity of all human epidermal growth factor receptors. The goal of the study is to determine whether the combination of the 2 drugs will either delay or decrease the appearance of treatment resistance.
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.
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?
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.
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.
Similar Survival, Safety for Bevacizumab Biosimilar vs Originator in Colorectal Cancer
February 8th 2025A retrospective observational study found no significant differences in progression-free survival or safety in patients with colorectal cancers in Japan treated with ABP 215, Amgen’s bevacizumab biosimilar, or reference bevacizumab (Avastin), and estimated cost savings of 800,000 Japanese yen (approximately $5100) per patient with the biosimilar.