Alteogen gains patent on SC trastuzumab biosimilar

Home/Pharma News | Posted 10/05/2019 post-comment0 Post your comment

South Korean biologicals company Alteogen announced on 27 March 2019 that it had gained a patent for a subcutaneous version (ALT LS2) of its candidate trastuzumab biosimilar (ALT L2).

Patent 2 V13E31

The company has patented a formulation for ALT LS2, a subcutaneous injectable formulation that incorporates human hyaluronidase technology into its trastuzumab biosimilar (ALT L2) for breast cancer therapy.

Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast and gastric cancers, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast and gastric cancers.

Alteogen said that it was planning to file additional patent applications and Patent Cooperation Treaty applications in 12 countries, including Europe and the US. The company expects that the patent will enable it to monopolize the market for subcutaneous injectable biosimilar trastuzumab.

The patents on the originator trastuzumab, Roche’s Herceptin, will expire in the US in June 2019 and already expired in Europe in July 2014 [1], Herceptin had 2018 worldwide sales of CHF 7.0 billion (US$7.5 billion).

This is not the first time Alteogen has gained patents for biosimilars. The company also won a process patent for its aflibercept biosimilar (ALT L9) in January 2019 [2].

1. Derbyshire M. Patent expiry dates for best-selling biologicals: 2017 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1):29-34. doi:10.5639/gabij.2018.0701.007
2. GaBI Online - Generics and Biosimilars Initiative. Alteogen wins process patent for aflibercept biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 10]. Available from:

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Source: Alteogen

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