Foley Partner Antoinette Konski authored an article that appeared in the September 2011 issue of BioProcess International titled “Generic Biologics.” Konski reviews several key provisions of various regulatory pathways for generic biologics in the United States, China, India and throughout Europe, and discusses how these pathways could support biosimilar manufacturing.
Click here to read the complete article.
Authors
Related Insights
29 November 2023
Article
International Trade, Enforcement & Compliance Recent Developments Update (November 29, 2023)
Did you know that whistleblowers can use the False Claims Act to get the U.S. government to investigate allegations of lost revenue to the U.S. Treasury, including underpaid customs tariffs? A large importer recently found this out.
29 November 2023
Manufacturing Industry Advisor
Who Regulates My Product?
In the world of healthy food and beverages, a crucial first step towards bringing a new product to the crowded U.S. market is identifying and understanding the regulatory authorities that oversee your product.
29 November 2023
Manufacturing Industry Advisor
What Every Multinational Company Should Know About . . . Implementing an International Compliance Program (Part I)
Record penalties for violations of U.S. regulations governing international conduct and transactions illustrate the risk of costly enforcement actions facing multinational companies.