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.
The economic insights and tools related to pharmaceutical competition developed during the decades of brand-generic Hatch-Waxman disputes will be useful in analyzing biologic-biosimilar competition in BPCIA disputes. However, insights and tools developed and routinely applied by economists in the contexts of small molecule brand-brand (e.g., Lipitor-Zocor) and brand-branded generic (Wellbutrin XL-Budeprion XL) competition and biologic brand-brand (e.g., Humira-Enbrel) competition will be also valuable in BPCIA disputes.
Biosimilar product launches, such as the anticipated launch of Inflectra later this year, are expected to pick up pace. As the launch of biosimilars in the U.S. picks up momentum, so too will the number of high-stakes biologic-biosimilar disputes. The traditional economic analysis employed for Hatch-Waxman brand-generic disputes, while still useful, will not be sufficient to guide irreparable harm and other economic analysis in this new life sciences competitive landscape. In this Law360 article, Michal Malkiewicz explores how critical it is that sound economic tools and insights from cases across life sciences are used in biologic-biosimilar disputes.