[PDF][PDF] The complexities of biosimilars and the regulatory approval process
S Lucio - Am J Manag Care, 2018 - ajmc.s3.amazonaws.com
The potential for a biosimilar class of drugs came into existence via the Biologics Price
Competition and Innovation Act (BPCIA) of 2009, itself a part of the Patient Protection and …
Competition and Innovation Act (BPCIA) of 2009, itself a part of the Patient Protection and …
Developing the nation's biosimilars program
S Kozlowski, J Woodcock, K Midthun… - … England Journal of …, 2011 - Mass Medical Soc
Developing the Nation's Biosimilars Program | New England Journal of Medicine Skip to main
content The New England Journal of Medicine homepage Advanced Search SEARCH The New …
content The New England Journal of Medicine homepage Advanced Search SEARCH The New …
Regulatory and cost barriers are likely to limit biosimilar development and expected savings in the near future
HG Grabowski, R Guha, M Salgado - Health Affairs, 2014 - healthaffairs.org
In March 2010 Congress established an abbreviated Food and Drug Administration
approval pathway for biosimilars—drugs that are very similar but not identical to a reference …
approval pathway for biosimilars—drugs that are very similar but not identical to a reference …
[PDF][PDF] Biosimilars: biologics that meet patients' needs and healthcare economics
M McCamish, W Yoon, J McKay - Am J Manag Care, 2016 - ajmc.s3.amazonaws.com
REPORT own versions of these biologics, which have been described as “follow-on
biologics” or “biosimilars.” In the United States and the European Union, biosimilar is a …
biologics” or “biosimilars.” In the United States and the European Union, biosimilar is a …
Optimizing use and addressing challenges to uptake of biosimilars.
MB Leber - The American Journal of Managed Care, 2018 - europepmc.org
With the passing and implementation of the Biologics Price Competition and Innovation Act
in 2010, biosimilars became a new classification of FDA-approved drugs. The biosimilar …
in 2010, biosimilars became a new classification of FDA-approved drugs. The biosimilar …
Perspectives on the current state of the biosimilar regulatory pathway in the United States
MK Dougherty, I Zineh, L Christl - Clinical Pharmacology & …, 2018 - Wiley Online Library
The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) created an
abbreviated licensure pathway in the United States that allows for the development and …
abbreviated licensure pathway in the United States that allows for the development and …
The US biosimilars act: challenges facing regulatory approval
C Nick - Pharmaceutical Medicine, 2012 - Springer
Ever since the signing of the US healthcare reform legislation, the Patient Protection and
Affordable Care Act (PPAC), speculation as to what a US FDA biosimilar programme might …
Affordable Care Act (PPAC), speculation as to what a US FDA biosimilar programme might …
Biologics are not natural monopolies
A Brill, B Ippolito - Health Affairs Forefront, 2019 - healthaffairs.org
Recently, several physicians and health policy analysts took to the Health Affairs blog to
propose what was, to anyone who has been following biosimilars for the last decade or …
propose what was, to anyone who has been following biosimilars for the last decade or …
[HTML][HTML] Biosimilar cost savings in the United States: initial experience and future potential
AW Mulcahy, JP Hlávka, SR Case - Rand health quarterly, 2018 - ncbi.nlm.nih.gov
Abstract The Biologics Price Competition and Innovation Act (BPCIA), enacted as part of the
2010 Patient Protection and Affordable Care Act (ACA), authorized the US Food and Drug …
2010 Patient Protection and Affordable Care Act (ACA), authorized the US Food and Drug …
US Biosimilar pathway unlikely to be used
C Wiatr - BioDrugs, 2011 - Springer
In March 2010, the US passed the healthcare reform bill, including The Biologics Price
Competition and Innovation Act of 2009, which established an abbreviated Biologic License …
Competition and Innovation Act of 2009, which established an abbreviated Biologic License …