European Commission Grants Marketing Authorization for Adalimumab and Trastuzumab Biosimilars

Last week the European Commission granted marketing authorization for two biosimilars.

First, Sandoz, a division of Novartis, announced on July 27 that it had received marketing authorization for Hyrimoz, its adalimumab biosimilar to AbbVie’s Humira.  Authorization was granted for all indications of the reference biologic, including rheumatoid arthritis, plaque psoriasis, Crohn’s disease, uveitis, and ulcerative colitis.  Sandoz’s Hyrimoz was shown to match the reference biologic in safety, efficacy, and technical quality.  This is Sandoz’s seventh biosimilar approval in Europe.  Approval from Hyrimoz also follows approval for four other adalimumab biosimilars in Europe: Amgevita and Solymbi by Amgen, Cyltezo by Boehringer Ingelheim, and Imraldi by Samsung Bioepis.  Humira is currently the world’s highest selling drug, and reportedly generated approximately $18.4 billion in sales in 2017.

Second, on July 31, Pfizer announced that it had received marketing approval for Trazimera, its trastuzumab biosimilar to Roche/Genentech’s Herceptin.  Trastuzumab treats breast and gastric cancers involving overexpression of the protein human epidermal growth factor (HER2).  The approval was based on research that showed clinical equivalence between Trazimera and the reference product.  This is Pfizer’s fourth biosimilar to receive approval in Europe and its first approval of an anticancer biosimilar.  European patent protection for Herceptin expired in 2014, and Trazimera joins four other trastuzumab biosimilars that are currently on the market.