EMA Recommends Approval of Two Biosimilars

January 27, 2017

The agency recommended approval of a total of eight drugs at its January 2017 meeting, two of which are biosimilars.

The European Medicines Agency (EMA) announced that its Committee for Medicinal Products for Human Use (CHMP) recommended eight drugs for market authorization at its latest meeting, held Jan. 23–26, 2017. Among the approvals were two biosimilars for the treatment of rheumatoid arthritis.

Several of the recommendations were for treatments of various forms of arthritis:

  • Xeljanz (tofacitinib) for the treatment of rheumatoid arthritis

  • Amgevita (adalimumab), a biosimilar, for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, hidradenitis suppurativa, Crohn's disease, pediatric Crohn's disease, ulcerative colitis and uveitis

  • Solymbic (adalimumab), a biosimilar, for the treatment of rheumatoid arthritis, enthesitis-related arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis and uveitis.

  • Jylamvo (methotrexate), a hybrid, for the treatment of rheumatological disorders and psoriasis. It was also approved for the maintenance treatment of acute lymphoblastic leukaemia (ALL).

CHMP also recommended Yargesa (miglustat) and Daptomycin Hospira (daptomycin), both generics. Yargesa treats Gaucher disease, and Daptomycin Hospira is a treatment for complicated skin and soft-tissue infections (cSSTI), right-sided infective endocarditis (RIE) due to Staphylococcus aureus and Saureus bacteraemia associated with RIE or with cSSTI.

Positive opinions were granted for two informed consent applications: Rolufta (umeclidinium) for the treatment of chronic obstructive pulmonary disease (COPD) and Tadalafil Lilly (tadalafil) for the treatment of erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia. 

The committee also recommended extensions of indications for Revlimid and Synjardy and withdrew marketing authorization for Zioxtenzo (pegfilgrastim), a biosimliar medicine to treat neutropenia in cancer patients, and Xgeva (denosumab), for the treatment of hypercalcemia of malignancy (high levels of calcium in the blood caused by cancer).

Source: EMA