The next 12 to 18 months are likely to be a critical time for an industry at the forefront of 21st century health care — biosimilars. Congress enacted landmark legislation in 2010 creating an expedited FDA approval pathway for these products, and the biosimilars industry has begun to grow rapidly.
But the U.S. Food and Drug Administration and the courts are now considering several important aspects of the biosimilars statutory and regulatory framework, and their decisions will determine the industry’s full potential as it comes of age.
This content has been archived. It is available through our partners, LexisNexis® and Bloomberg Law.
To view this content, please continue to their sites.
Not a Lexis Subscriber?
Subscribe Now
Not a Bloomberg Law Subscriber?
Subscribe Now
LexisNexis® and Bloomberg Law are third party online distributors of the broad collection of current and archived versions of ALM's legal news publications. LexisNexis® and Bloomberg Law customers are able to access and use ALM's content, including content from the National Law Journal, The American Lawyer, Legaltech News, The New York Law Journal, and Corporate Counsel, as well as other sources of legal information.
For questions call 1-877-256-2472 or contact us at [email protected]
