2017 a record breaking year for biosimilars approvals

The number of first approvals for biosimilars in the USA, Japan, or European Union 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, according to a new analysis.

Analytics firm GlobalData notes that the US Food and Drug Administration alone approved five new biosimilar products, bringing the number of approved biosimilars in the USA from four to nine. This includes two products for oncology use: Mylan (Nasdaq: MYL) and Biocon’s (BSE: 532523) Ogivri, which is a biosimilar to Genentech’s Herceptin (trastuzumab) and Amgen (Nasdaq: AMGN) and Allergan’s (NYSE: AGN) Mvasi, which is a biosimilar to Genentech’s Avastin (bevacizumab).

The European Medicines Agency approved eight new biosimilars, including biosimilars of AbbVie’s (NYSE: ABBV) Humira (adalimumab), Genentech’s Rituxan (rituximab) Herceptin, Eli Lilly’s Humalog (insulin lispro injection), and Eli Lilly’s (NYSE: LLY) 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.