An In-Depth Analysis of Alteogen's Herceptin Subcutaneous Biosimilar Program

I. Executive Summary

Alteogen Inc. is a biopharmaceutical company strategically advancing a Herceptin (trastuzumab) biosimilar program that notably includes both an intravenous (IV) formulation, designated ALT-L2 (also developed with Qilu Pharmaceutical as QL-1701), and a differentiated subcutaneous (SC) formulation, ALT-LS2. The development of ALT-LS2 is critically dependent on Alteogen's proprietary Hybrozyme™ platform technology, specifically its novel recombinant human hyaluronidase enzyme, ALT-B4.[1]

Significant progress has been made, particularly with the IV formulation. ALT-L2, in partnership with Qilu Pharmaceutical, has successfully completed Phase III clinical trials and has been launched in the Chinese market, establishing an initial revenue stream through royalties for Alteogen and validating the company's trastuzumab molecule.[3] The SC formulation, ALT-LS2, is positioned as a higher-value product. Its development leverages Alteogen's patents related to SC trastuzumab formulations and the broader validation of the ALT-B4 technology, which has been licensed to several major global pharmaceutical companies—including MSD (for Keytruda SC), AstraZeneca, Daiichi Sankyo (for Enhertu SC), Sandoz, and Intas—for use with their respective innovator or biosimilar products.[2]

The market for Herceptin biosimilars is characterized by increasing competition. However, SC formulations present clear advantages in terms of patient convenience and efficient use of healthcare resources, a trend underscored by the market success of Roche's originator SC product, Herceptin Hylecta.[7] Alteogen's ALT-LS2 aims to capitalize on this demand for improved delivery methods.