Global Development of Biosimilars: Understanding and Reducing Regulatory Uncertainty in the USA
Posted on March 4, 2016
By: Ajaz S. Hussain, Ph.D.
Insight Advice and Solutions LLC. Frederick, MD 21702, USA*, and The National Institute for Pharmaceutical Technology & Education
Introduction Development of biosimilars for markets such as EU and USA can take 7 to 8 years and cost of between $50 million and $250 million. It is important to safeguard these large investments in development of biosimilars and it may be desirable to aim for one ‘global development’. The US is...
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Related Topics and Keywords
Ajaz S. Hussain, BPCIA, Development of biosimilars, efficient regulatory pathway, interchangeable biosimilar, National Institute of Pharmaceutical Technology and Education, regulatory uncertainty, The Biologics Price Competition and Innovation Act of 2009
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