In the EU, certolizumab pegol has been approved for use in pregnant and nursing women with chronic rheumatic disease…
2 Biosimilars Make Their Way Toward the European Market
Two biosimilar treatments, Rixathon and Imraldi, are moving closer to market release in Europe for the treatment of rheumatic and other diseases…
EMA Panel Recommends Nod for Sanofi, Regeneron’s Arthritis Drug
(Reuters)—A European Medicines Agency panel said on Friday it recommended granting marketing approval to Sanofi and Regeneron’s experimental drug to treat rheumatoid arthritis (RA). The Committee for Medicinal Products for Human Use gave a positive opinion on the drug, sarilumab (Kevzara), citing its ability to reduce the signs and symptoms of RA. Sarilumab, the active…
EMA Flags Faulty Generic Drug Data, Backs Sales Halt
(Reuters)—The European Medicines Agency (EMA) recommended suspending sales of some generic drugs after a review found that data collected by a contract research company in India for their approval was unreliable. The EMA’s list included drugs made by some of the top generic drugmakers, including Teva Pharmaceutical Industries Ltd., Mylan NV and Novartis AG’s Sandoz….
Spanish Drugmaker Fears Disruption if EMA Moves from Britain
MADRID (Reuters)—The likely relocation of the European Medicines Agency (EMA) from London threatens to disrupt the approval of new drugs and is a medium and long-term worry for top Spanish drugmaker Almirall, its chief executive says on Monday. The EMA, Europe’s equivalent the U.S. Food and Drug Administration, approves medicines for all European Union countries…
Europe Launches New Fast Approval Scheme for Promising Drugs
LONDON (Reuters)—European regulators launched a new scheme on Monday to speed the approval of promising new drugs that address unmet medical needs by offering enhanced support to medicine developers as they work on clinical trials. The European Medicines Agency‘s (EMA) initiative called PRIME, which stands for PRIority MEdicines, is the latest example of regulators on…
Biosimilars Seek Regulatory Approval in the U.S. & Europe; Plus MTX Underused in the U.S.
In Europe, an etanercept biosimilar is getting closer to being approved to treat RA and more, and in the U.S., an application for an adalimumab biosimilar has been submitted for FDA approval. Also, an analysis of methotrexate use in the U.S. shows that therapy may actually be underused for RA…
Smarter Regulation Can Help Cut Drug Prices, Says EU Agency Head
LONDON (Reuters)—Europe’s top drug regulator weighed into the medicine pricing debate on Wednesday, arguing a smarter and faster pharmaceutical approval system was needed to help rein in the spiraling cost of new treatments. In exchange for speeding up the approval process, society would expect manufacturers to charge less for innovative medicines, European Medicines Agency (EMA)…