Amgen has filed the first biosimilar version of AbbVie’s anti-inflammatory super-blockbuster Humira in the European Union, in the hope of offering a cheaper alternative to the drug and thus potentially improving access to it.
The drugmaker is seeking permission to market ABP 501, a biosimilar to the anti-TNF-_ monoclonal antibody, which is approved across a range of inflammatory diseases and pulls in annual sales of more than £13 billion, making it the world’s number-one selling drug last year.
Amgen says its filing, which also marks the firm’s first for a biosimilar in the Europe Union, is supported by data from Phase III Studies in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis, which met their primary goals in showing clinical equivalence to adalimumab and a comparable safety profile.
While pricing information isn’t yet available, biosimilars are coming out at around 20%-30% than their branded reference drugs without compromising on safety or efficacy, which is quite an attractive proposition to healthcare systems particularly during the current financial climate.
The European submission for ABP 501 comes just days after a marketing application for the biosimilar was submitted in the US.
Merck, Amgen in immunotherapy pact
Meanwhile, Amgen and Merck & Co have announced a cancer immunotherapy collaboration to support a Phase Ib/III study investigating Blincyto (blinatumomab) in combination with Keytruda (pembrolizumab) in patients with diffuse large B-cell lymphoma (DLBCL), which is the most common type of non-Hodgkin lymphoma (NHL).
Blincyto is Amgen's CD19 bispecific T cell engager and Keytruda is Merck's anti-PD-1 therapy, and the companies are exploring whether their combination will offer a more powerful treatment approach for DLBCL patients.
The companies have also announced a second immunotherapy cancer collaboration to support a Phase I/II study of AMG 820, Amgen's anti-colony-stimulating factor 1 receptor (CSF1R) antibody, in combination with Keytruda in patients with select advanced solid tumours, including non-small cell lung, colorectal and pancreatic cancers.