South Korean biosimilar developer Celltrion has begun development of a pembrolizumab biosimilar, targeting Merck & Co's blockbuster immunotherapy Keytruda, while simultaneously preparing to launch its trastuzumab biosimilar in Europe following recent regulatory approval.
The PD-1 checkpoint inhibitor pembrolizumab has become a cornerstone treatment across multiple tumor types, generating $3.8 billion in revenue for Merck in 2017. Analysts project the drug could achieve peak annual sales exceeding $7 billion by its patent expiration in June 2028. Celltrion claims to be ahead of competitors by initiating development a full decade before potential market entry.
Herceptin Biosimilar Gains European Approval
Celltrion's trastuzumab biosimilar, Herzuma, received EU approval, positioning the company to compete with Samsung Bioepsis's Ontruzant, which gained European approval in November. European payers have reportedly delayed tender processes until both products reach the market to maximize pricing negotiations.
HoUng Kim, Celltrion's head of strategy and operations, stated that the company's trastuzumab biosimilar will be priced up to 50% cheaper than Roche's subcutaneous Herceptin. He emphasized Celltrion's competitive advantage through superior data packages, including stability data, and a compelling overall value proposition compared to Samsung Bioepsis.
Market Dynamics Favor Subcutaneous Formulation
Roche has successfully defended its Herceptin franchise through a patent-protected subcutaneous formulation that now represents 50% or more of the European market. The biosimilar competitors will launch intravenous-only versions, limiting their addressable market to less than $1 billion in total European sales.
The subcutaneous formulation offers significant convenience advantages, requiring half the hospital time compared to intravenous administration. This positioning challenge means biosimilar manufacturers are competing for a shrinking segment of the overall trastuzumab market.
Long Development Timeline Reflects Complexity
The extended development timeline for the pembrolizumab biosimilar reflects the inherent complexity of biosimilar development, which industry experts compare to "baking a cake without the recipe." Celltrion's early start demonstrates strategic planning for what could become a highly competitive market upon patent expiration.
Celltrion has established itself as a global biosimilar pioneer through successful launches of Remsima (infliximab) and Truxima (rituximab). The company positions its pipeline as superior to competitors including Novartis's Sandoz division and fellow South Korean company Samsung Bioepsis.
Herceptin generated $2.26 billion in revenues for Roche in the previous year, making it an attractive target for biosimilar development despite the market segmentation challenges posed by the subcutaneous formulation's dominance.
