On 2 September 2026, South Korean-headquartered Alteogen announced that it has entered into an option and licence agreement with Novartis for the development and commercialisation of subcutaneous (SC) formulations of Novartis products using Alteogen’s ALT-B4 drug delivery technology. The Novartis products to be developed into SC formulations have not been disclosed.
ALT-B4 is a recombinant human hyaluronidase enzyme platform (berahyaluronidase alfa) which enables the conversion of biologics typically administered via intravenous infusion into more convenient and rapid SC formulations.
If Novartis’ multiple options under the agreement are exercised and all milestones are achieved, Alteogen is eligible to receive up to US$3.2 million, comprising option exercise fees, development and commercial milestone payments and royalties on net sales of products commercialised under the agreement.
The agreement with Novartis is the latest in a series of deals entered into by Alteogen in relation to the use of ALT-B4 in the development of subcutaneous formulations of biopharmaceutical and biosimilar products. This includes a January 2026 agreement with Tesaro, a GSK subsidiary, for development of SC Jemperli® (dostarlimab); a 2019 exclusive licence, confirmed in June 2026, with Sanofi for development of a high dose SC formulation of Dupixent® (dupilumab), a November 2024 exclusive licence agreement with Daiichi Sankyo for SC Enhertu® (trastuzumab deruxtecan); a January 2023 agreement with Sandoz for an SC formulation of an undisclosed biosimilar; and the development of SC Keytruda® (pembrolizumab) with MSD, which has been approved including in the US as Keytruda Qlex™ (September 2025), EU (November 2025), Canada (February 2026) and Korea (May 2026).
Interest in subcutaneous formulations of antibody drug products is continuing to increase. For example, on 21 August 2026, Huonslab announced that it secured Korean patent registration, and filed a PCT application, for its recombinant human-derived hyaluronidase-based formulation conversion platform technology (HyDIFFUZE™), applied to 11 antibody therapeutics, including pembrolizumab, bevacizumab and dupilumab. A recent collaboration between Sandoz and Shanghai Henlius Biotech provides Sandoz with an option for a recombinant human hyaluronidase (HLXTE-Haase1001) to be used in the development of an SC biosimilar. At the end of July 2026, it was announced that Celltrion is partnering with Korean-based G2GBIO to convert antibody drugs to SC formulations. Meanwhile, MSD is currently engaged in litigation with Halozyme in the US and Europe in relation to Halozyme’s MDASE subcutaneous delivery technology and SC Keytruda® (pembrolizumab).