Novartis/Sandoz Biosimilar Erelzi OK'd; Covets Enbrel's US Sales
Novartis AG unit Sandoz Inc. won US approval of its biosimilar Erelzi, which is referenced on Amgen's tumor necrosis factor blocker Enbrel (etanercept). The product, however, currently is caught in a patent dispute, although a recent stipulation has provided some hope for a smoother path through the legal jungle than other biosimilars may face.
You may also be interested in...
Amgen started 2018 off on solid footing with a 2% jump in Q1 revenue to $5.55bn versus consensus estimates of $5.4bn, but new drugs like the CGRP inhibitor Aimovig are needed to keep the momentum going and supplement declining sales for key products.
Amgen signaled future declines in revenue for its top-selling product Enbrel during its third quarter conference call as payer pressure on drug pricing and competition mounts.
Pfizer commits to “late November” launch for its biosimilar version of infliximab, partnered with Celltrion, which will be the second biosimilar to reach the US market. Remicade innovator Janssen considers it an “at risk” launch and will continue patent litigation, as well as commercial tactics to protect its market.