Bevacizumab biosimilar on the way

Amgen and Allergan today announced the submission of an application to the FDA for a biosimilar candidate to bevacizumab (ABP 215). The companies believe this submission is the first bevacizumab biosimilar application submitted to the FDA.

Included in the submission is data from a phase 3 study conducted in patients with lung cancer, showing no clinically meaningful difference between the biosimilar and bevacizumab in terms of efficacy, safety and immunogenicity. Bevacizumab is also used off-label for ophthalmic purposes.

"Allergan is committed to developing safe and effective therapies in certain critical disease areas," said David Nicholson, Chief R&D Officer at Allergan. "The filing of ABP 215 is an important step forward in advancing a potential treatment option for patients with disorders susceptible to VEGF inhibition."

Amgen and Allergan are collaborating on the development and commercialization of 4 oncology biosimilars. Amgen has a total of 9 biosimilars in its portfolio. One has won FDA approval (adalimumab-atto) and 8 are in development.