EMA recommends market approval of four biologics

The CHMP experts said that two biosimilar TNF alpha blockers met the comparability criteria vs Enbrel (etanercept), the originator developed by Amgen: Pfizer’s Lifmior (etanercept) as treatment for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, pediatric plaque psoriasis, and axial spondyloarthritis. Additionally, the agency extended the label of Samsung Bioepis/Biogen’s Benepali (etanercept) to treat juvenile idiopathic arthritis and pediatric plaque psoriasis in patients weighing more than 62.5kg. The acceptance of the company’s type II variation application complements the indications already that got market approval in January 2016 (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis, and plaque psoriasis). Additionally the EMA okayed EU approval of Celltrion’s Truxima (CT-P10), a biosimilar version of Roche’s first generation CD20 blocker rituximab to treat non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), RA, granulomatosis with polyangiitis and microscopic polyangiitis.

On the antibody side, the CHPM recommended authorisation of Merck & Co’s Zinplava (bezlotoxumab) to prevent infections with Clostridium difficile.

The agency also said that two targeted therapies met its criteria for EU market approval: Roche’s ALK and RET blocker Alecensa (alectinib) is recommended for conditional market approval in adult crizotinib-refractive patients with ALK-positive non small cell lung cancer (NSCLC). Finally, the CHMP  backed market authorisation of Eli Lilly’s JAK blocker Olumiant (baricitinib) to treat moderate to severe active rheumatoid arthritis.