In the subcutaneous injection (SC) platform market led by U.S.-based Halozyme and domestic Alteogen(196170), latecomers are accelerating development of SC biosimilars (biosimilar) applying their own technologies. As SC biosimilars using proprietary platforms emerge in a market once centered on converting global blockbuster drugs to SC, competition is diversifying.
According to the industry on the 19th, corporations developing biosimilars have recently been securing their own recombinant human hyaluronidase (PH20) technologies one after another and are moving to develop SC biosimilars using them.
◇ Halozyme and Alteogen lead the global blockbuster SC conversion market
SC conversion technology is cited as a key investment area in the global industry. Converting an intravenous (IV) infusion that requires hours in a hospital to an SC injection that can be given in minutes greatly improves patient convenience. In addition, launching blockbuster drugs facing patent expiration in SC formulations secures new patents and extends product life, prompting global big pharma to adopt the approach.
Since 2014, the number of SC formulation approvals has steadily increased. Last year, more than 30% of antibody drugs approved by the U.S. Food and Drug Administration (FDA) were SC.
The core of SC conversion is recombinant human hyaluronidase (PH20). Hyaluronidase is an enzyme that temporarily breaks down hyaluronic acid in subcutaneous tissue to help drugs spread and be absorbed quickly, and is used to convert existing IV therapies to SC formulations. Hyaluronidase-based SC platforms are led by Halozyme's "ENHANZE" and Alteogen's "ALT-B4."
Halozyme expanded the market by using ENHANZE to develop Roche of Switzerland's "Herceptin SC," Johnson & Johnson (J&J) of the United States' "Darzalex SC," and Janssen's "Rybrevant SC."
Alteogen likewise used ALT-B4 to develop the SC formulation of Merck (MSD)'s No. 1 global immuno-oncology drug "Keytruda," called "Keytruda Qurex," secured FDA approval, and is on the market. It is expanding applications to the antibody-drug conjugate (ADC) therapy "Enhertu" from AstraZeneca of the United Kingdom and Daiichi Sankyo of Japan, and to Sanofi of France's atopic dermatitis treatment "Dupixent."
Recently, the Huons(243070) group has also been pushing to sign platform technology licensing deals with global pharmaceutical companies, led by the recombinant human-derived hyaluronidase-based SC conversion platform "Hy-D-Fuse" from Huons Global(084110) subsidiary Huons Lab.
◇ Henlius, Celltrion, and Samsung Bioepis take on SC biosimilars with proprietary platforms
While Halozyme and Alteogen focus on platform businesses that convert original drugs from global big pharma to SC formulations, latecomers are concentrating on developing SC biosimilars using their own hyaluronidase technologies.
A representative case is Henlius, a subsidiary of China's Fosun Pharma. Applying its proprietary recombinant human hyaluronidase (rHuPH20) platform "Henozye," Henlius is developing "HLX319," a biosimilar of Roche's HER2-positive breast cancer therapy "Phesgo (pertuzumab·trastuzumab)."
Phase 1 is underway in China and is expected to be completed in October. Given the recent trend of streamlined biosimilar trials, there is talk that Phase 3 could be waived.
Henozye is a platform that temporarily breaks down hyaluronic acid in subcutaneous tissue to reduce tissue resistance and increase the dispersion and absorption of high-volume drugs. The company plans to apply the platform to various modalities, including bispecific and multispecific antibodies, fusion proteins, and antibody-drug conjugates (ADC).
In Korea, Celltrion(068270) is the most advanced. Celltrion began a registrational clinical trial in Feb. last year for "Herzuma SC (CT-P6 SC)," its first SC biosimilar using its own hyaluronidase platform. Herzuma SC is a biosimilar of Roche's breast cancer therapy "Herceptin." In Aug. last year, it also launched a trial for "CT-P44," a biosimilar of the multiple myeloma therapy "Darzalex SC."
Samsung Epis Holdings(0126Z0) subsidiary Samsung Bioepis also recently completed internal validation of its own hyaluronidase platform and filed related cell culture and purification process patents. The company is currently reviewing ways to use the technology.