The EU’s CHMP has given the green light to Imraldi, Samsung Bioepis’ biosimilar version of AbbVie’s blockbuster adalimumab product Humira. If approved by the European Commission, this will be the South Korean company’s third biosimilar anti-TNF alpha product to gain a marketing authorization in the EU.

Quality data will be focus of ‘extra advice’ offered by European Medicines Agency’s pilot, which will suggest directions for sponsors’ next steps but stop short of formal data evaluation.

After US FDA's Oncologic Drugs Advisory Committee voted to delay approval of Karyopharm's multiple myeloma drug Xpovio, the company submitted some data from the Phase III BOSTON trial, which prompted the FDA to award an accelerated approval for a narrower indication.