On November 15, 2019, FDA approved Pfizer’s adalimumab product, a biosimilar to AbbVie’s Humira, marking the 25th approval of a biosimilar under the Biologics Price Competition and Innovation Act (BPCIA). A biosimilar is a...more
FDA (Finally!) Issues New Regulations to Clarify Pharmaceutical Patent Litigation: How to Use Patent “Use Codes” -
October 6, 2016, the FDA issued a final rule implementing certain provisions of the Medicare...more
11/29/2016
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On October 6, 2016, the FDA issued a final rule implementing certain provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) governing the approval of generic drugs, including...more