OBJECTIVES: Immuno-oncology therapies have revolutionized cancer treatments; however, these significant survival improvements are accompanied by high prices, with the most attractive biologic targets generating revenues greater than $5 billion USD. While these biologics have faced minimal competition in recent years, a large proportion now face U.S. patent expiry prior to 2030, opening the door for new biosimilar development, launches, and robust competition. This abstract will explore the next wave of biosimilar assets, particularly targeted oncology therapies, and provide a better understanding of the future biosimilar landscape and expected challenges that drug manufacturers will encounter as they compete to win market share.

METHODS: A targeted review of the landscape of biosimilar candidates in development. This analysis explored key characteristics that may be associated with an opportunity for competitive advantage and launch success. These included biologic factors, clinical and development features, and company profile information.

RESULTS: We analyzed 26 biosimilar candidates. The majority of biosimilars in development are for Opdivo (N=9), Keytruda (N=7), Darzalex (N=2), and Tecentriq (N=1). The majority of assets represent two biologics with global revenues of $17.2 B (Keytruda) and $7.5B (Opdivo). Only three of these early assets are in Phase 1, 50% are in preclinical development, 20% in discovery phase, and 15% in IND/CTA File stage. The majority are being developed globally, with a few biosimilars targeting single markets such as China and Brazil. They are nearly split in targeting a single indication or 2+ indications. This abstract further explores how these characteristics can have a direct impact on a product’s success in the market, (i.e. targeted indication, potential indication extrapolation policies).

CONCLUSIONS: Due to potential policy changes, market barriers, and originator defense strategies, many key players are hiding their pipeline, resulting in a greater need to understand key characteristics that enable a successful launch and differentiate against competition.