Samsung Bioepis internalized subcutaneous (SC) formulation technology based on PH20 as global biosimilar competition expands into formulation conversion. Big pharma companies are extending market exclusivity by transitioning blockbuster drugs to SC formulations, prompting biosimilar developers to secure independent SC platforms. The SC biopharmaceutical market is projected to grow from $286.3 billion to $498.9 billion by 2031 according to Mordor Intelligence.
Samsung Bioepis Targets Keytruda and Enhertu Biosimilars with SC Technology
Samsung Bioepis is reviewing SC formulation applications for its biosimilar pipeline. The company is currently developing biosimilars for Keytruda and Enhertu, with industry observers noting high likelihood of prioritizing SC formulations for these two products. An industry source stated that the timing of development initiation will be critical, as waiting for original SC product patent expiration could delay market entry.
MSD's Keytruda generated $31.7 billion in sales last year as the world's top-selling cancer drug. MSD plans to convert 40% of the entire Keytruda market to the SC formulation Keytruda Qurex by the end of next year, creating a $12.7 billion SC formulation market by simple calculation. Samsung Bioepis internalized PH20-based SC technology and handles cultivation and purification processes with proprietary technology.
Celltrion Conducts World's First SC Biosimilar Clinical Trials
Celltrion already internalized PH20-based technology and initiated development of SC biosimilars for Herceptin and Darzalex last year. The company has been conducting regulatory clinical trials for Herjuma SC (CT-P6 SC) since February last year and started clinical trials for its Darzalex biosimilar SC formulation (CT-P44) in August last year. Celltrion is also reviewing expansion of formulation conversion CMO business for new drugs and external clients. Samsung Bioepis confirmed it is not considering external provision of formulation conversion technology.
Johnson & Johnson received FDA approval for Darzalex Faspro, the SC formulation of Darzalex, in 2020. Within approximately two years, the company converted over 80% of existing Darzalex infusion patients (85% in the US, 80% in Europe) to Darzalex Faspro. This left biosimilar companies with less than 20% of the market ahead of Darzalex (IV) patent expiration in 2030. SC formulations reduce administration time from several hours to several minutes compared to IV formulations and shorten hospital stays, earning high preference from both patients and medical staff.
Exclusive Licensing Agreements Limit SC Technology Access
Global biosimilar companies including Switzerland's Sandoz and India's Intas licensed SC formulation conversion technology from Korean company Alteogen. However, Alteogen signed exclusive contracts with MSD for Keytruda components and with Daiichi Sankyo for Enhertu components. Sandoz and Intas face difficulties applying Alteogen technology to Keytruda and Enhertu biosimilars. Halozyme, which participated in developing SC formulations for blockbusters including Herceptin, Darzalex, and Rituxan, also provides technology exclusively.
An industry source noted that platform companies signing exclusive contracts by component with big pharma created a situation where biosimilar companies without proprietary technology must wait until SC formulation patents expire. The source projected that proprietary technology carries relatively lower risk despite not completely excluding patent dispute possibilities, and offers the advantage of application to various products once patent issues are resolved.
Samsung Biologics Plans PFS Production Expansion by 2027
Samsung Bioepis's affiliate Samsung Biologics plans to expand production lines for prefilled syringes (PFS) and autoinjectors used in SC formulations by 2027. These facilities can be derivatively utilized for drug product (DP) production of SC formulation biosimilars. Celltrion's affiliate Celltrion Pharmaceutical disclosed plans to invest 2 trillion won in the Chungcheong region to expand PFS production capacity from the current 20 million syringes annually to 70 million syringes.
FAQ
What SC formulation technology did Samsung Bioepis develop?
Samsung Bioepis internalized PH20-based subcutaneous (SC) formulation technology and handles cultivation and purification processes with proprietary technology. The company is reviewing SC formulation applications for biosimilars currently in development including Keytruda and Enhertu.
What is the projected size of the SC biopharmaceutical market?
Mordor Intelligence projects the global SC biopharmaceutical market will grow from $286.3 billion to $498.9 billion by 2031. MSD plans to convert 40% of the Keytruda market to SC formulation by the end of next year, creating a $12.7 billion SC formulation market by simple calculation.
