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Friday, June 28, 2013
EU CHMP recommends ten new medicine for approval including two first two monoclonal antibody biosimilars
In one of the busiest
meetings of 2013 so far, the Committee recommended ten new medicines for approval, including the first two monoclonal antibody biosimilars, and a new advanced therapy medicine. These medicines are intended for patients suffering from diseases including cancer, multiple sclerosis and other auto-immune diseases.
Ten new medicines recommended for approval
recommended granting of marketing authorisations for the first two monoclonal antibody biosimilars.
are recommended for authorisation in the same indications as Remicade (infliximab), a monoclonal antibody that has been authorised in the European Union (EU) since 1999.
Three medicines to treat cancer received positive opinions from the
a cell-based therapy for the treatment of metastatic castrate-resistant prostate cancer, which is also the fourth advanced therapy
to be recommended for
, for the treatment of unresectable or metastatic melanoma with a BRAF V600 mutation; and
for the treatment of metastatic colorectal cancer.
for the management of cystinosis
for the treatment of multiple sclerosis.
(Fenofibrate / simvastatin) as adjunctive therapy to diet and exercise, to reduce triglycerides and increase HDL-cholesterol levels in adults with mixed dyslipidemia with high cardiovascular risk
for the short-term treatment of reflux symptoms in adults,
for the treatment of haemostasis, and as an adjunct to haemostasis.
of two initial recommendations for
adopted a positive
, revising its previous opinion not to grant new
status to the medicine at its March 2013 meeting.
adopted a final negative opinion following the
Five recommendations for extensions of indications
of the existing
Eylea, Evicel, Onglyza, Velcade
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