EMA Recommends 9 New Medicines, Including Biosimilars

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP), the European Union (EU)’s drug regulatory agency, recommended the approval of 9 new medications, 3 of which are biosimilars, at its April 2017 meeting. The 3 recommended biosimilars are all products of Sandoz.

CHMP recommended granting marketing authorization for etanercept-szzs (Erelzi; a biosimilar of reference drug Enbrel), for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis, and pediatric plaque psoriasis. Etanercept-szzs, which inhibits tumor necrosis factor-alpha, will be available and injectable solution. (The EU approved another etanercept biosimilar, Benepali, in January 2016.) The 2 other recommended biosimilars, are follow-on biologics to rituximab (Rituxan in the US and MabThera in the EU): Rixathon and Riximyo, and are indicated for the treatment of non-Hodgkin’s lymphoma, RA, granulomatosis with polyangiitis, and microscopic polyangiitis. Rixathon has an additional indication for the treatment of chronic lymphocytic leukemia. Both Rixathon and Riximyo will be available as a 500-mg and 100-mg concentrate for infusion. (The EU approved another rituximab biosimilar, Truxima, in February 2017.)

CHMP also recommended 2 orphan medications for the treatment of 2 different rare neurodegenerative conditions in children. Biogen’s nusinersen (Spinraza), indicated for the treatment of spinal muscular atrophy (SMA), was reviewed under an accelerated assessment program. There is currently no approved treatment for SMA in the EU. The second orphan pediatric drug to be recommended was BioMarin Pharmaceutical’s cerliponase alfa (Brineura), for the treatment of neuronal ceroid lipofuscinosis (CLN2) type 2 disease. Brineura was also reviewed under an accelerated assessment program. There are currently no medicines approved for CLN2 treatment, only options that address symptoms.

The other recommended medications are:

• Pfizer’s inotuzumab ozogamicin (Besponsa ), which was recommended for the treatment of acute lymphoblastic leukemia (ALL) and has an orphan designation. Besponsa will be the first antibody drug conjugate to become available for treatment of ALL.
• Sanofi’s sarilumab (Kevzara), which was recommended for the treatment of RA. Sarilumab is an interleukin-6 receptor inhibitor that will be available as a solution for subcutaneous injection in both pre-filled syringes and pre-filled pens. Kevzara was shown in clinical trials to inhibit the progression of joint damage in RA patients.
• Almirall’s dimethyl fumarate (Skilarence) was recommended as a first-line induction and long-term treatment for adults with moderate to severe plaque psoriasis. Skilarence will be available as 30-mg and 120-mg gastro-resistant tablets.
• CMP Orphan’s trientine tetrahydrochloride (Cuprior), another orphan drug, was recommended for the treatment of Wilson’s disease, a rare autosomal recessive inherited disorder.