Reviewing 2005: The Top Biopharma Stories
Among our stop stories from 2005: Safety and the FDA: decision by indecision; ahe Plan B kerfuffle; acquisition as the new exit strategy for private biotechs; TLRs-the hottest drug target; pricing revives vaccines; Pfizer's challenges and Genentech's triumphs. Among the predictions for the big stories of 2006: Medicare's impact, the oncology bubble, biogenerics and genomics' revival--via diagnostics.
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Our review of top stories of 2006 touches on a variety of subjects, but the majority drive to one über-theme: the pipeline challenge. Products suddenly disappeared into the generic abyss, with nothing new to take their places. Compounds likely to succeed didn't. The price of in-licensable products soared. Even relatively good news for pipelines largely reflected the absence of further bad news: the safety squabbles did not result in higher hurdles to product approvals.
The dust at Pfizer still hasn't settled as new CEO Jeff Kindler shakes up the senior office suite at the world's largest pharmaceutical company. But the dust hasn't obscured the basic message: Pfizer's strategic and managerial model hasn't worked. What's more, the Big Pharma's board is one of a handful in the industry coming to similar conclusions.
Biosimilars' time has come--in Europe, at least. The European regulators asserted during a workshop in Paris at the beginning of December that biosimilars guidelines will be finalized before mid-2006. This will open up a market which could be worth $8 billion within five years in the EU, according to the European Generic Association (EGA).