Introduction
Biologic drug products are used to treat a variety of serious diseases, including cancer, blindness, rheumatoid arthritis, multiple sclerosis, and diabetes. Biologics, which include antibodies and large proteins, tend to be more complex than traditional small molecule drugs. Biologics are typically manufactured in living cells, and the manufacturing processes can be exquisitely sensitive to small environment changes, for example, in temperature or nutrient content.
In 2015, biologics accounted for 38 percent of U.S. prescription drug spending, and they also accounted for 70 percent of the growth in drug spending from 2010 to 2015.1In 2017, eight of the top selling drugs were biologics.
In 2010, Congress passed the Biologics Price Competition and Innovation Act (BPCIA), which established an abbreviated pathway2to market for biosimilars. Biosimilars are often referred to as generic versions of innovator biologics.3To date, the U.S. Food and Drug Administration (FDA) has licensed 11 biosimilars. As part of a broader emphasis on encouraging biologics market competition, the FDA recently published its Biosimilars Action Plan (the BAP).4
Biosimilar Action Plan
The FDA’s BAP contains four key elements:
While a comprehensive review of the BAP is beyond the scope of this alert, some key points include:
Conclusion
The proposed actions outlined in the BAP, in conjunction with initiatives like the Biosimilar Product Development program (BPD program),8should facilitate a more transparent path to market for biosimilars. For questions regarding the BAP, or any biosimilar-related questions, please contact David Hoffmeister or any member of the firm’s FDA regulatory practice.