31.10.2012 - With AET Biotech Ltd. and BioXpress SA, two new players join the queue of Humira copycats.
The two partners pool their expertise in the manufacturing of biologicals and in development and marketing. The TNF-alpha blocker is a promising target with projected global sales of more US$9bn this year. Malta-based AET BioTech Ltd. is the biosimilars operation of German generic drugs firm Alfred E. Tiefenbacher GmbH & Co. KG in Hamburg. BioXpress S.A. is a Swiss biotech focused on the development of monoclonal antibody biosimilars.
The firms aim to jointly develop the biosimilar to registration, based on BioXpress expression technology. AET will shoulder commercialisation of the resulting antibody and will, in addition, provide further investment in terms of committed long-term financing. The Humira patent runs out in 2016. However, Abbott is trying to prevent biosimilar competition by legal action. Furthermore, larger players like Boehringer Ingelheim are already developing Humira follow-on biologics. Humira has an interesting history. Originally the drug was developed by German BASF AG who sold its pharma business to Abbott.
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26.05.2015 The Finnish Medicines Agency Fimea has joined the Dutch MEB in its stance on the interchangeability of biosimilars. The Fimea now sees physician-driven switching of biologics as unproblematic.
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