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IMAP Pharmaceuticals and Biotech Industry Report - 2012

IMAP Pharmaceuticals and Biotech Industry Report - 2012

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Fight for the biosimilar market takes an unexpected turnMany generic companies expected additional growth in the next years to come from biosimilars, copycat products of biotech drugs.The definition of the regulatory process for biosimilars has been lengthy <strong>and</strong> to some extent unpredictable, <strong>and</strong> the resulting uncertaintywas generally considered a major roadblock for the development of the biosimilar market.In 2011 the situation changed as more clarity regarding the regulatory process was established.But as the regulatory path to biosimilars was cleared, the competitive l<strong>and</strong>scape completely changed as new <strong>and</strong> unexpected allianceswere built. Several originator biotech companies entered strategic alliances with new, sometimes unforeseen, partners to enterinto the biosimilar field (see table below).While the Fujifilm / Hanwha <strong>and</strong> Richter / Stada deals rather resemble a “normal” drug development licensing arrangement, theAmgen / Watson (not targeting Amgen’s biotech drugs) <strong>and</strong> Biogen / Samsung (not targeting, of course, Biogen’s biotech drugs) areclearly an unusual partnership.It remains to be seen if these alliances will be successful. Lonza’s JV with Teva, signed in 2009 with a similar intention as the alliancesformed last year, should provide results soon. Clearly, the new partnerships profoundly change the race for the distribution of thebiosimilar market. And the number of deals involving <strong>Biotech</strong> firms in this short time span also indicates the wariness of the <strong>Biotech</strong>originators towards generic competition.8

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