The FDA recently released draft guidance concerning the labeling of biosimilar products (analogous in the biologic context to generic drugs). It’s called, not surprisingly “Labeling for Biosimilar Products Guidance for Industry.” Here’s a link to it on the FDA’s website.
When we think of bioequivalence, we think of generic drugs, and more specifically generic drug preemption under PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and its progeny. Generic preemption, as we’ve discussed many times, depends on the impossibility of making an immediate change to a product (including its labeling) as required by state law, where the same change necessitates prior approval by the FDA under federal law. So we took a look at the guidance to see whether biosimilar products were likely to enjoy the same protection from state-law product liability.
It doesn’t look that way.