Biosimilar Biological Products: An Introduction
A session from FDLI’s Introduction to Biologics: Vaccines, Biosimilars, Cell and Gene Therapies, and More
Recorded March 5–6, 2024
Biosimilar Biological Products: An Introduction
Understand background and definitions of biologic and biosimilar drugs and new drug applications (NDAs) and biologics license applications (BLAs). Summarize biosimilar pathways to market and application contents. Learn about the types of meetings available to interact with FDA. Examine interchangeability standards and conditions of use.
Krista Hessler Carver, Partner, Covington & Burling LLP
This session was recorded as part of FDLI’s Introduction to Biologics: Vaccines, Biosimilars, Cell and Gene Therapies, and More Course in March 2024.
KRISTA HESSLER CARVER is a partner at Covington & Burling LLP in Washington, DC. Ms. Carver’s practice focuses on FDA regulatory and legislative matters for clients in the pharmaceutical and biotechnology industries. Ms. Carver counsels clients on an array of FDA regulatory issues, including orphan-drug designation and exclusivity, priority review vouchers, FDA’s expedited programs, pediatric testing, risk evaluation and mitigation strategies (REMS), and Hatch-Waxman and biosimilars issues. Ms. Carver also assists clients with advocacy before FDA, including formal dispute resolution requests and citizen petitions, and with legislative issues concerning amendments to the Federal Food, Drug, and Cosmetic Act. Ms. Carver received her JD, magna cum laude, from Harvard Law School and her BS in Chemistry, summa cum laude, from William & Mary.Get Access
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