Sandoz proposed biosimilars rituximab and etanercept recommended for approval in Europe
Sandoz, announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions, separately recommending the approval of both Sandoz’ biosimilar rituximab and biosimilar etanercept in Europe.
The products are recommended to treat the same indications as their respective reference medicines.
“We are proud to help patients in Europe with blood cancers and immunological diseases by improving their access to effective treatments through the potential approval of not just one, but two new Sandoz biosimilar medicines,” said Mark Levick, MD PhD, Global Head of Development, Biopharmaceuticals, Sandoz. “Today’s recommendations from the CHMP will not only benefit patients, but they demonstrate our leadership in biosimilars and the strength of the Sandoz and Novartis immunology and oncology portfolios”.
The CHMP recommendations were based on two comprehensive development programs in which analytical, preclinical and clinical – including pharmacokinetic/pharmacodynamic – data were generated. The programs demonstrated biosimilarity of biosimilar rituximab and etanercept to their respective reference medicines.
Sandoz has a leading biosimilar pipeline and, in addition to biosimilar rituximab and etanercept (Erelzi approved in 2016 by the FDA), plans to launch three more biosimilars of major oncology and immunology biologics across key geographies by 2020.
Source: Sandoz press release