Last December, Amgen submitted its biosimilar version of Roche’s oncology biologic Avastin (bevacizumab) for approval to the European Medicines Agency (EMA), and in a recent investor presentation the firm said its trastuzumab candidate ABP 980 is also up for review.
The breast cancer monoclonal antibody (mAb) added around CHF 6.8bn ($6.9bn) to Roche’s 2016 results, around 30% of which was in Europe.
But though the submission shows Amgen has ambitions on this $2bn plus market, it is one of at least three biosimilar developers to have filed their versions of Herceptin with the EMA. Mylan/Biocon’s proposed candidate was accepted for review last August, and Samsung Bioepis’ version followed suit in October.
According to Amgen’s presentation from March 8, ABP 980 is yet to have been submitted to the US Food and Drug Administration (FDA) for review, though this is planned for the near future.
Mylan and Biocon are believed to be the first firms to have a Herceptin biosimilar accepted for review in the US, with the FDA setting a Biosimilar User Fee Act (BsUFA) target action date of September 3.
Amgen’s version of Avastin – also estimated to make Roche $7bn annually – has a BsUFA target action date of September 14 in the US.
In total, Amgen’s biosimilar portfolio targets worldwide originator sales of $60bn, with versions of Remicade (infliximab), Rituxan (rituximab), Soliris (eculizumab), Erbitux (cetuximab) and three undisclosed molecules in the development pipeline.
Amjevita, Amgen’s version of AbbVie’s $16bn global best-seller Humira, became the first adalimumab biosimilar to be approved in the US last September. Two European versions – named Amgevita and Solymbic – were recommended in the EU in January.