The number of first approvals for biosimilars in the US, Japan, or EU has increased significantly in the past two years, breaking the stagnation of the three years prior, with 2017 setting a new record for number of first approvals in a single year.
The FDA alone approved five new biosimilar products, bringing the number of approved biosimilars in the US from four to nine. This includes two products for Oncology use: Mylan and Biocon’s Ogivri, which is a biosimilar to Genentech’s Herceptin (trastuzumab); and Amgen and Allergan’s Mvasi, which is a biosimilar to Genentech’s Avastin (bevacizumab).
The European Medicines Agency (EMA) approved eight new biosimilars, including biosimilars of AbbVie’s Humira (adalimumab), Genentech’s Rituxan (rituximab), Herceptin, Eli Lilly’s Humalog (insulin lispro injection), and Eli Lilly’s Forsteo (teriparatide). With 23 additional unique drugs currently in pre-registration, GlobalData believes that it is likely that this trend of biosimilar approvals will continue in 2018.