Drug maker Alteogen has announced that it will file an Investigational New Drug (IND) application with the FDA for its proposed biosimilar aflibercept (ALT-L9), an anti–vascular endothelial growth factor therapy referencing Regeneron’s Eylea, during 2018.
Drug maker Alteogen has announced that it will file an Investigational New Drug (IND) application with the FDA for its proposed biosimilar aflibercept (ALT-L9), an anti—vascular endothelial growth factor therapy referencing Regeneron’s Eylea, during 2018.
According to The Investor, Alteogen, based in the Republic of Korea, has completed US-based preclinical studies of ALT-L9 that demonstrated that the proposed biosimilar is similar to the reference, and says that it will present official preclinical data within the next 3 months. The preclinical toxicity study was conducted in animals during a 13-week period. Pulse News reports that the biosimilar developer will initiate global clinical trials soon after it receives an official report on the animal test results.
“We plan to present the official analysis report of the preclinical results at an academic conference and expect licensing-out negotiations to be accelerated,” Alteogen CEO, Soon-Jae Park, said in a statement.
According to Alteogen, ALT-L9 is also more resilient to high temperatures, and has a longer shelf life, than the originator drug because of the biosimilar developer’s formulation technology.
The 1 additional biosimilar in Alteogen’s pipeline is a proposed trastuzumab molecule, ALT-02. The drug reportedly underwent phase 1 studies in Canada in 2016, and phase 3 clinical trials for the drug were slated to begin in 2017. The drug maker also reports that it is developing a so-called “biobetter” (a therapy that has resulted from intentionally altering a biologic product in order to improve its clinical effects) of a monoclonal antibody using the company’s proprietary antibody-drug conjugate technology.
Alteogen is not the first biosimilar developer to announce progress on an aflibercept product during this month; Momenta Pharmaceuticals and its partner Mylan announced on January 3 that they will initiate a pivotal clinical trial of M710, in 2018. On January 8, biosimilar developer Coherus announced at the 36th Annual J.P. Morgan Healthcare Conference that its CHS-2020 has initiated preclinical development.