Alteogen is among a number of contenders vying to bring aflibercept biosimilars to market. Key patents on the originator begin to expire in 2023.
Alteogen, a Daejeon, Republic of Korea biopharmaceutical developer, said it has successfully completed a phase 1 clinical trial of an aflibercept biosimilar referencing Eylea.
Investigators said the Alteogen biosimilar candidate (ALT-L9) and the originator product were randomized 1:1 to 28 patients with neovascular age-related macular degeneration in a double-blind, controlled trial. They said no adverse drug-related reactions were observed in either patient cohort and improvements in best corrected visual acuity and central subfield thickness were similar across the groups.
“In this phase 1 clinical trial, Alteogen confirmed the safety and efficacy of ALT-L9 were similar to that of Eylea,” the company said in a statement. The company hopes to complete an accelerated phase 3 trial using the results of the phase 1 trial.
Eylea is a flagship product for Regeneron, a Tarrytown, New York–based company that garnered $4.9 billion in US aflibercept revenues in 2020, up 7% from 2019.
In the statement, Alteogen said it hopes to potentially be the first to launch an aflibercept biosimilar, although it did not specify which market. The phase 1 trial was conducted at 4 hospitals in Korea. However, the company said it has strengthened the biosimilar candidate’s potential with a formulation patent registered in the United States, European Union, and Japan.
“Alteogen is uniquely positioned based on our patent position to launch a Eylea biosimilar upon substance patent expiration,” said Soon Jae Park, CEO. “Our patent position will give us a potentially commercial first-mover advantage.”
Regeneron has stated that its US and EU composition-of-patents for aflibercept will expire in 2023 and 2025, respectively. The company also has manufacturing, formulation, and administration regimen patents that expire at later dates. Regeneron has also stated intentions to try to extend the Eylea exclusivity window by filing more patent claims. In China and Japan, the product loses patent protection in 2022, offering an earlier market opportunity for Alteogen.
Alteogen does have competition. Formycon and Bioeq have teamed up on development and licensing of their own aflibercept biosimilar candidate (FYB203). They announced a phase 3 equivalence study for the biosimilar in August 2020.
Momenta, Amgen, and Coherus BioSciences, and Samsung Bioepis each have aflibercept biosimilar candidates of their own.