Health Care & Hospital Law,
Administrative/Regulatory
Feb. 24, 2020
FDA, FTC issue joint statement on efforts to support market for biologics
To help ensure increased biosimilar licensing and consumer and healthcare provider awareness of the benefits of biosimilars, the Food and Drug Administration and the Federal Trade Commission recently issued a joint statement identifying four joint goals regarding the market for biologics
Georgia C. Ravitz
Georgia was a partner in Wilson, Sonsini, Goodrich & Rosati PC's life sciences practice, where she specializes in FDA regulatory, health care, and consumer products innovation and compliance. Prior to joining the firm, Georgia was a senior partner in the FDA and advertising practices of Arent Fox in Washington, D.C., where she led the firm's consumer product safety practice.
James R. Ravitz
Partner
Jamie was a partner in Wilson Sonsini's life sciences practice, representing manufacturers and distributors of products regulated by the FDA, including medical devices, drugs, biologics, food, cannabis, dietary supplements, and cosmetic products. Before joining the firm, Jamie led the FDA and health care life sciences practice at Arent Fox in Washington.
David M. Hoffmeister
Partner
Wilson Sonsini Goodrich & Rosati PC
David plays a major leadership role in the firm's drug and device regulatory and health care law practice and brings more than 25 years of experience in drug and device regulatory and health care law. David was named as one of the "25 Leading Biotech Attorneys" in California in 2011 by the Daily Journal, and is recognized as one of the leading food and drug regulatory lawyers in the country.
Vern Norviel
Partner
Wilson Sonsini Goodrich & Rosati PC
Vern is a senior practitioner in the firm's Patents and Innovations Strategies practice.
Jeffrey W. Guise
Partner
Wilson Sonsini Goodrich & Rosati PC
Email: jguise@wsgr.com
Dr. Guise is a senior practitioner in the firm's Patents and Innovations Strategies practice.
Charles Andres
Senior counsel
Wilson Sonsini Goodrich & Rosati PC
Charles is senior counsel in the firm's Patents and Innovations Strategies practice and the firm's U.S. Food and Drug Administration, Healthcare, and Consumer Products Compliance practice.
Biologics are complex drugs that include antibodies, living cells such as CAR-T cells that are used to treat cancer, and may soon include artificially produced organs for human transplant. Biologics, because of their complexity, are often more expensive and difficult to manufacture than traditional small molecule drugs. Biologics can be exquisitely sensitive to small alterations in production processes, ambient environmental conditions, or media materials. All of thes...
For only $95 a month (the price of 2 article purchases)
Receive unlimited article access and full access to our archives,
Daily Appellate Report, award winning columns, and our
Verdicts and Settlements.
Or
$795 for an entire year!
Or access this article for $45
(Purchase provides 7-day access to this article. Printing, posting or downloading is not allowed.)
Already a subscriber?
Sign In