Demand for biologics is growing fast, but even after Congress passed authorizing legislation in 2010, the pace of generic entry appears to have stalled. Seeking to spur increased generic competition, the FTC held an all-day workshop earlier this week to discuss evolving FDA and state regulations, especially on the key issues of substitutability and naming rules for follow-on biologics. While the workshop participants did not reach consensus, the debate was lively and provided much for the FTC to consider as it continues to examine and weigh in on the topic.View memo, FTC Workshop Seeks to Spark Biosimilars Competition
