ALT-L2: Herceptin biosimilar
· Alteogen is currently developing ALT-L2, a biosimilar of Herceptin (Trastuzumab), a monoclonal antibody for the treatment of breast cancer.
· Herceptin is an original biologic of Roche. It is a blockbuster monoclonal antibody drug, which sold USD 7 billion globally as of 2016. With great efficacy and little side effects, it has shown higher growth rate in comparison with other antibody drugs. The growth rate is even higher in Asia because it is prescribed for the treatment of breast cancer as well as gastric cancer. Asia has high number of gastric cancer patients, and usage of Herceptin for the gastric cancer approved as of 2010 in Asia has reinforced true potential of Herceptin.
· Substance patent for original Herceptin expires in 2014 and 2019 for Europe and the US respectively. Accordingly, multiple of pharmaceutical companies are currently developing Herceptin biosimilars.
· Alteogen has been developing ALT-L2 with its strategic alliance partner, Cristalia of Brazil, and successfully completed the phase I clinical trial in Canada. The phase III clinical trials will be underway after completion of necessary preparatory works.
Research | Process | Pre-clinical | Phase 1 | Phase 2 | Phase 3 | ||
---|---|---|---|---|---|---|---|
ALT-L2 | Herceptin Biosimilar | ||||||
BLA in China |
ALT-L2 | Herceptin Biosimilar |
---|---|
BLA in China | |
Research | |
Process | |
Pre-clinical | |
Phase 1 | |
Phase 2 | |
Phase 3 |