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Regulatory NEWS
NO BOOSTER, SINGLE DOSE
Entering the marketplace battle for HIV-1 share with a new fixed-dose pill is Viiv Healthcare Ltd., the joint venture between Glaxosmithkline plc and New York-based Pfizer Inc., which won the go-ahead from U.S. regulators last week for Triumeq.
PRICED LIKE CEREZYME
First to market with an all-oral first-line therapy for adults with Gaucher disease type 1, the most common form, is the Genzyme unit of Paris-based Sanofi SA, which gained FDA marketing clearance for Cerdelga (eliglustat), giving patients an option to the infused enzyme replacement therapy (ERT) Cerezyme (imiglucerase), also developed by Genzyme.
LONDON – With the number of biosimilars approved in Europe on the rise, the UK Bioindustry Association (BIA) and the Association of the British Pharmaceutical Industry (ABPI) have joined forces in a publicity campaign to ensure prescribers are aware that – unlike small-molecule generics – biosimilars are not straight swaps for the originator products.
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