Amgen's Biosimilar BLA For ABP 501 Submitted To FDA

On Nov. 25, 2015 Amgen announced the submission of a Biologics License Application (BLA) with the United States FDA for ABP 501, a biosimilar candidate to Humira (adalimumab). This represents Amgen's first BLA submission using the 351(k) biosimilar pathway.

ABP 501 is a biosimilar candidate to adalimumab, an anti-TNF-α monoclonal antibody, which is approved in many countries for the treatment of various inflammatory diseases. Amgen's BLA submission includes analytical, clinical, and pharmacokinetic data. Phase III comparative efficacy and safety studies were conducted in both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis.

The Phase III studies met their primary endpoints, showing clinical equivalence to adalimumab. Safety and immunogenicity of ABP 501 were also comparable to adalimumab. Data to support the transition of adalimumab patients to ABP 501 are included in the submission.

It was initially unclear whether or not Amgen was in support of the development of biosimilars. The company previously said minor changes in formulation may have significant affects on patient safety.

During an Oct. 28, 2015 third-quarter earnings call Amgen CEO, Bob Bradway, said the company was preparing to file clinical trial data with the FDA for ABP 501, and expected legal pushback from AbbVie, the original developer of Humira.

AbbVie CEO Richard Gonzalez has said the company plans to aggressively defend its patents for Humira from biosimilar competitors, many of which will protect the product until 2022. AbbVie currently has 70 patents protecting Humira, and the company expects nearly $18 billion in global sales will come from Humira alone.

Amgen currently has nine biosimilar molecules in development, and is expected to launch ABP 501 in 2017.

Source: Amgen