Amgen and Allergan submit biologics license application to US FDA for ABP 215

16 November 2016 (Last Updated November 16th, 2016 18:30)

Amgen and Allergan have submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for ABP 215.

Amgen and Allergan have submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for ABP 215.

ABP 215 is a biosimilar candidate to bevacizumab, a recombinant immunoglobulin G1 monoclonal antibody (mAb) that binds to vascular endothelial growth factor (VEGF) and reduces the interaction of VEGF with its receptors, VEGF receptor-1 and VEGF receptor-2.

Bevacizumab is approved in the US, EU and other regions for the treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous non-small-cell lung cancer (NSCLC).

Amgen research and development executive vice-president Sean Harper said: "ABP 215 is one of four oncology biosimilars in our pipeline, and today's BLA submission is an important milestone as Amgen seeks to expand our oncology portfolio.

"ABP 215 has the potential to offer an additional high-quality therapeutic option for patients diagnosed with cancer, continuing Amgen's mission of providing patients with vital medicines."

The submission was based on analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data.

"The submission was based on analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data."

In a Phase III study conducted in adult patients with non-squamous NSCLC, bevacizumab showed no clinically meaningful difference in terms of efficacy, safety and immunogenicity.

Amgen has a total of nine biosimilars in its portfolio, while Allergan is independently developing biosimilars.

The two companies collaborated in December 2011 to develop and commercialise four oncology antibody biosimilar medicines on a global basis.

Amgen has assumed the primary responsibility for developing, manufacturing and initially commercialising the oncology antibody products.


Image: Micrographs of squamous cell carcinoma. Photo: courtesy of Nephron.