Biosimilars Oncology Roundup: November 2023

The Center for Biosimilars^® covered an abundance of oncology news during November, especially during Global Biosimilars Week 2023, which was themed around the growth of oncology biosimilars.

Global Biosimilars Week 2023 Recap

Global Biosimilars Week (GBW) is an annual awareness campaign hosted by the International Generic and Biosimilar Medicines Association (IGBA) where stakeholders from around the world are encouraged to share the benefits of biosimilars and the current barriers impacting utilization, acceptance, affordability, and accessibility, of these lower-cost biologics. 2023 marks the fourth GBW event and the third year The Center for Biosimilars has served as a media partner.

As part of the partnership, IGBA and The Center for Biosimilars hosted a live webinar where panelists discussed the remaining global challenges to ensuring worldwide access to oncology biosimilars. The panelists dived into the different policy considerations affecting biosimilar approvals and how stakeholders can collaborate to expand global cancer care. Those who missed the live event can watch the full webinar here.

The Center for Biosimilars also conducted a 3-part article series in honor of GBW. Each part focused on a different aspect of global use of oncology biosimilars. Part 1 covered an international study from China that looked at the clinical and economic impact of oncology biosimilars and how Chinese regulatory authorities can adjust their policies to promote biosimilar use.

Part 2 was about a French analysis that quantified the cost-effectiveness of using subcutaneous (SC) vs intravenous (IV) trastuzumab products for treating HER2-positive breast and gastric cancers. The researchers evaluated the use of IV trastuzumab biosimilar as a replacement for IV and SC reference trastuzumab, as well as the use of SC reference trastuzumab to replace IV reference trastuzumab.

Part 3 focused on a European investigation of whether clinical efficacy studies have an impact on prescribing decisions for oncology biosimilars. The analysis also highlighted the need for a comprehensive approach that includes both quality/chemistry, manufacturing, and controls and clinical data to ensure patient safety and efficacy of biosimilars.

Denosumab Updates and Other News

Another Chinese study demonstrated comparable pharmacokinetic (PK), pharmacodynamic (PD), and safety between a denosumab biosimilar candidate (LY01011) and its reference product (Xgeva) in healthy participants. The single-center, randomized, double-blind, single-dose, active comparator, parallel-controlled analysis sought to provide phase 1 data in hopes for the biosimilar to move on to trials in patients with advanced malignancies that have metastasized to bones.

Samsung Bioepis shared data from a separate phase 1 study and a phase 3 study for its denosumab biosimilar (SB16) at the American Society for Bone and Mineral Research 2023 Annual Meeting in Canada. The phase 1 study demonstrated comparable PK and PD parameters with the reference product, and the phase 3 study demonstrated biosimilarity between the 2 products in patients with postmenopausal osteoporosis.

Additionally, the Community Oncology Alliance's (COA) Board of Directors announced the creation of the Drug Policy and Regulation Committee, which will seek to provide solutions that will ensure patients and practices have stable and affordable access to current and future drug products, including innovators, generics, and biosimilars. The committee consists of 7 COA members, including Kathy Oubre, MS, CEO of Pontchartrain Cancer Center and a member of The Center for Biosimilars’ Advisory Board.

In other news, a review of 12 phase 1 studies and 4 phase 3 studies found similar safety profiles between pegfilgrastim biosimilars and their reference product (Neulasta). Across the trials, 2978 patients received a biosimilar and 3787 received the reference product. The biosimilars studied were 4 pegfilgrastim products approved in the United States (Ziextenzo, Stimufend, Nyvepria, and Udenyca).

Finally, a retrospective study of 1156 patients with cancer receiving trastuzumab or bevacizumab in New England found that combining dose rounding and biosimilar use initiatives resulted in greater cost savings than either strategy alone, addressing the growing costs associated with cancer care.