The biosimilar market is shifting its focus from price to formulation. As subcutaneous (SC) formulations gain traction in the previously intravenous (IV)-dominated biopharmaceutical sector, domestic companies are actively developing related products and securing technology.
According to market research firm Mordor Intelligence, the global SC biopharmaceutical market grew from $257.5 billion last year to $286.3 billion this year, and is projected to reach $498.9 billion by 2031.
The rising popularity of SC formulations is attributed to their convenience. Unlike IV formulations that require lengthy hospital visits for administration, SC formulations allow for shorter administration times and self-administration, significantly reducing the burden on patients. For healthcare providers, this also lowers the operational burden of managing infusion rooms, enhancing their utility.
Patient preference for SC administration is evident. In a study of Roche's Tecentriq SC formulation, 70.7% of respondents preferred the SC method due to reduced administration time and the avoidance of discomfort associated with intravenous catheter insertion. Some U.S. insurers have begun covering 90-95% of IV costs for home administration, further promoting the adoption of SC formulations.
Domestic companies are also working to enhance their competitiveness in SC formulations. Celltrion is pursuing approval for its Herjuma SC formulation following the world’s first commercialization of Remsima SC. Herjuma is a biosimilar of Roche's breast cancer treatment Herceptin (trastuzumab), competing with Roche's original Herceptin and Celltrion's IV biosimilar Herjuma in the domestic trastuzumab market.
Herjuma SC is the first SC biosimilar to utilize Celltrion's hyaluronidase platform. While the existing IV formulation requires approximately 90 minutes for administration, the SC version can be administered in under five minutes. As there are currently no approved trastuzumab SC biosimilars, Herjuma SC could gain a first-mover advantage if approved.
A Celltrion representative stated, "Based on our in-house SC formulation transition technology, we will secure new pipelines and strengthen our global competitiveness, including growth in contract development and manufacturing organization (CDMO) services for formulation changes."
Alteogen is also targeting the global market with its SC conversion platform. ALT-B4 is the key substance in Alteogen's SC formulation change platform. The company revealed on June 18 that Sanofi was the first licensing partner for SC formulation conversion using ALT-B4, based on the Hybrozyme platform agreement signed in 2019. This marks the first public disclosure of a global technology export partner after years of confidentiality.
The potential for additional commercialization is expanding. Sanofi is currently conducting a Phase 1 clinical trial for a high-dose SC formulation of Dupixent using ALT-B4.
Alteogen demonstrated the competitiveness of its platform when Merck's (MSD) Keytruda SC, utilizing its technology, was commercialized last year. Keytruda SC received a permanent J-code in the U.S. in April. The J-code simplifies the billing process for hospitals and insurers, enhancing prescription accessibility. In South Korea, it received approval from the Ministry of Food and Drug Safety last month and is expected to launch in the fourth quarter of this year.
Hong Ga-hye, a researcher at Daishin Securities, projected that the Keytruda SC-related milestones could generate approximately 300 billion won this year, 400 billion won in 2027, and 500 billion won in 2028, adding that the revenue structure will likely shift from milestone and royalty-based to a focus on ongoing royalties.
* This article has been translated by AI.
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