The Biologics Price Competition and Innovation Act: Potential Problems in the Biologic-Drug Regulatory Scheme
نویسنده
چکیده
منابع مشابه
Worldwide experience with biosimilar development
Limited access for high-quality biologics due to cost of treatment constitutes an unmet medical need in the United States (US) and other regions of the world. The term "biosimilar" is used to designate a follow-on biologic that meets extremely high standards for comparability or similarity to the originator biologic drug that is approved for use in the same indications. Use of biosimilar produc...
متن کاملThe constitutional protection of trade secrets and patents under the Biologics Price Competition and Innovation Act of 2009.
The Biologics Price Competition and Innovation Act of 2009 ("Biosimilars Act") is for the field of pharmaceutical products the single most important legislative development since passage of the Drug Price Competition and Patent Term Restoration Act of 1984 ("Hatch-Waxman Act"), on which portions of the Biosimilars Act are clearly patterned. Congress revised section 351 of the Public Health Serv...
متن کاملThe economics of biosimilars.
BACKGROUND The high cost of pharmaceuticals, especially biologics, has become an important issue in the battle to control healthcare costs. The Hatch-Waxman Act encourages generic competition but still provides incentives for pioneers to develop new drugs. The Biologics Price Competition and Innovation Act is intended to do the same for biologics and biosimilars. OBJECTIVE To examine informat...
متن کاملBiosimilars: An Emerging Category of Biologic Drugs for Emergency Medicine Practitioners
Biologics are the fastest growing segment of annual United States (US) drug expenditure. Biologics are complex proteins derived from living sources that are important therapy for a variety of diseases. The US is now poised to introduce biosimilars, which are copies of biologics that are not manufactured by the innovator company and are approved under an abbreviated regulatory process. Biosimila...
متن کاملFollow-on biologics: competition in the biopharmaceutical marketplace.
OBJECTIVE To describe the implications of a follow-on biologic approval process with focus on current stakeholders, implications of the status quo, and recommendations for future policy. DATA SOURCES A search using Medline, International Pharmaceutical Abstracts, Med Ad News, F-D-C Reports/Pink Sheets, and Google index directories was conducted with terms such as biologic, biopharmaceutical, ...
متن کامل