Genzyme/Isis Gear Up For Long-awaited Kynamro Launch
Genzyme said it is ready to deliver product, but complying with the REMS that helped pave the way for approval is a time-limiting factor for launching the familial hypercholesterolemia drug. Drug will be priced at $176,000 per year, significantly lower than Aegerion’s competing Juxtapid.
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<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
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<p>Executive Summary</p> This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
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