York FaulknerFeb 23, 20218 minFDA Abbreviated Biologics Application ("aBLA") for Biosimilar ProductsAbbreviated Biologics Applications for biosimilar products are governed by 42 U.S.C. § 262. Section 262(k) requires an applicant seeking...
York FaulknerFeb 21, 20219 minPatent Disputes Regarding Biosimilar & Interchangeable Biological ProductsAs an overview, the patent dispute resolution procedures under the Biologics Act include (1) the confidential disclosure of the aBLA...
York FaulknerFeb 19, 202119 minProcedural Aspects of Generic Drug Patent Litigation... The Hatch Waxman Act also created a new framework for innovator-generic drug patent litigation that promotes early resolution of...