Biosimilars Oncology Roundup: June 2024

As the weather heats up for the US and Europe, so too did the 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.

News and Reports in Oncology

Some news came out of Europe and the US, with the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) adopting a positive opinion on Avzivi, a bevacizumab biosimilar for multiple cancers.

Additionally the FDA and the EMA have accepted applications for denosumab biosimilars, which can be used in patients with bone loss due to prostate or breast cancer. The FDA's acceptance concerned Fresenius Kabi's candidate, and the EMA's involved a product being developed by Shanghai Henlius Biotech and Organon.

A recent study outlined the challenges and solutions for increasing biosimilar adoption in oncology. It highlighted economic barriers such as reimbursement policies and pricing dynamics, as well as noneconomic barriers like provider and patient awareness. Strategies to overcome these included improving education on biosimilars, adjusting reimbursement policies to favor biosimilars, and enhancing collaboration among stakeholders. These efforts aimed to achieve cost savings and improve patient outcomes in oncology through increased biosimilar use.

Findings From EHA 2024 and ASCO 2024

Several posters came out of the 2024 annual meetings of the European Hematology Association (EHA) and the American Society of Clinical Oncology (ASCO).

Two studies presented at EHA 2024 evaluated the impact of rituximab biosimilars on patients with lymphatic cancers. The first study focused on quality of life (QOL) in patients with non-Hodgkin lymphoma and chronic lymphocytic leukemia (CLL), finding that while QOL was generally acceptable, functional well-being was most compromised. The second study assessed infusion-related reactions (IRRs) from rituximab biosimilars in patients with chronic lymphoproliferative disorders, finding comparable IRR rates to existing data, with specific conditions like diffuse large B-cell lymphoma and CLL showing different IRR frequencies.

At ASCO 2024, posters highlighted the safety and efficacy of trastuzumab and ado-trastuzumab biosimilars in HER2-positive cancers. A phase 2 study with 40 patients showed that combining trastuzumab biosimilar Herzuma with neratinib yielded a 23.1% objective response rate and manageable adverse events, particularly diarrhea. Another study on a biosimilar of ado-trastuzumab emtansine in 116 patients demonstrated similar efficacy and safety to the reference product, increasing accessibility for patients in low- and middle-income countries.

More posters analyzed Medicare reimbursement trends for biologics and biosimilars, and a pegfilgrastim biosimilar combined therapy in advanced hepatocellular carcinoma (HCC). The first study revealed that biosimilars reduced health care costs and drug reimbursement rates compared with reference agents. The second study demonstrated that combining SCT-I10A (anti-PD-1 monoclonal antibody) and SCT510 (bevacizumab biosimilar) improved overall survival and progression-free survival in patients with HCC compared with sorafenib, with an acceptable safety profile.

Additionally, 2 other ASCO posters highlighted the positive safety and efficacy data for denosumab and pegfilgrastim biosimilars. A denosumab biosimilar candidate (FKS518) showed therapeutic equivalence and similar safety to the originator in postmenopausal osteoporosis, with significant increases in bone mineral density. A systematic review and meta-analysis confirmed that pegfilgrastim biosimilars were effective in reducing the duration of severe neutropenia in patients receiving cytotoxic chemotherapy, with comparable safety profiles to the originator. Both studies emphasized the potential of biosimilars to improve patient access and reduce treatment costs.

Market Analyses With Oncology Implications

A commentary critiqued factors undermining biosimilar market sustainability and recommended long-term solutions. It highlighted how pricing and procurement practices led to rapid price erosions, affecting development and marketing costs. The authors emphasized the need for multistakeholder-supported principles based on collective action theory to create sustainable policies. They suggested cooperative strategies, incentive systems, and coordination across governance levels to reconcile competing interests and achieve long-term market sustainability. The commentary called for further research and stakeholder agreement for effective implementation.

Lastly, in the second part of the series on biosimilars and health equity, attention shifted to the obstacles hindering affordable biosimilar treatments, particularly among underserved communities. Key barriers highlighted include the influence of payers, pharmacy benefit managers (PBMs), and financial incentives that favor more expensive originator biologics over biosimilars. These incentives, managed by managed care organizations and PBMs, often lead to higher profits when originator biologics are prescribed, thus limiting the adoption and potential cost savings of biosimilars. Addressing these systemic issues through policy changes, enhanced education, and improved transparency among stakeholders is crucial to achieving equitable access to biosimilar therapies.