Intellectual Property,
Administrative/Regulatory
Aug. 28, 2014
Sandoz may bring clarity to biosimilars rules
Manufacturers of reference products and biosimilars await further guidance from the Federal Circuit as to the metes and bounds of the new regime ushered in by the BPCIA. By Jeffry S. Mann and Stephen Paul Mahinka
Jeffry S. Mann
Partner
Morgan Lewis & Bockius LLP
Jeffry is a partner the firm's intellectual property practice, which focuses on strategic counseling, intellectual property portfolio design, preparation and prosecution of patent applications, and licensing and due diligence primarily in the life sciences industry.
Stephen Paul Mahinka
Partner
Morgan Lewis & Bockius LLP
Stephen is the chair of the firm's life sciences and healthcare interdisciplinary group, and a member of the firm's FDA and Antitrust practices.
The global biosimilars market accounted for approximately $1.3 billion in revenue last year. By 2020, revenue attributable to biosimilars is anticipated to increase to $35 billion as market share for biosimilar products grow in the North American, European and Asian markets. An important consideration driving the growth in the biosimilars market is the "patent cliff" facing several biologics. Ten biologics are projected to lose patent protection during the next four years (e.g., Humira, sa...
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