Germany’s IQWiG: New Year, Same Sternness On Dossier Structure
This article was originally published in The Pink Sheet Daily
Pfizer’s kidney cancer drug Inlyta scrapes through the German added value assessment process but Almirall’s COPD product Eklira gets a “thumbs down,” showing that comparator selection is not the only deciding factor in the process.
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Germany’s powerful health care watchdog G-BA, in its first full opinion on early added benefit assessment of medicines, says the process is fair and promotes real drug innovation, in sharp contrast to the biopharma industry which maintains it is a cost-cutting tool wielded by health insurance funds.
Second-generation VEGF inhibitor Inlyta (axitinib) gained approval based as much on its complementary safety profile as its superiority in a head-to-head comparison with Bayer/Onyx’s Nexavar .
Forest pays $75 million up front for U.S. rights to Almirall's once-daily long-acting beta agonist in combination with a corticosteroid.