Economics Of Harm From Biologic-Biosimilar Competition

Law360, New York ( April 20, 2016, 11:55 AM EDT) -- For more than two decades and despite the Biologics Price Competition and Innovation Act of 2009, the Hatch-Waxman brand-generic disputes have dominated the life sciences competitive landscape. However, a new and highly anticipated biologic-biosimilar competition is finally a reality: look no further than the recent launch of Sandoz's filgrastim biosimilar Zarxio and anticipated launch of Celltrion's infliximab biosimilar Inflectra. The advent of this new type of competition is a big deal: in the U.S. alone, biologics market is estimated at more than $140 billion and more than 20 biologics with a market value of over $50 billion will lose patent protection by 2019. More than 50 percent of the U.S. prescription drug budget is expected to be biologics by 2018 and it is estimated that 40 percent of all pharmaceutical industry R&D and products in the pipeline involve biopharmaceuticals rather than traditional drugs.[1]...

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