Intellectual Property,
Administrative/Regulatory
Aug. 28, 2014
Biosimilars and the new road to FDA approval
Many fundamental issues concerning the BPCIA remain unresolved, making this regulatory pathway unattractive to some potential biosimilar manufacturers.
Biologics are a class of medicines that include protein-based products used to treat a disease or health condition. However, they differ from more traditional "small-molecule" drugs in that they are made by cellular processes or biotechnology. Biologics are large, complex molecules that are difficult to manufacture, characterize and compare to one another, and are extremely expensive to develop. While biologic products have revolutionized patient therapies for a variety of cancers and infl...
For only $95 a month (the price of 2 article purchases)
Receive unlimited article access and full access to our archives,
Daily Appellate Report, award winning columns, and our
Verdicts and Settlements.
Or
$795 for an entire year!
Or access this article for $45
(Purchase provides 7-day access to this article. Printing, posting or downloading is not allowed.)
Already a subscriber?
Sign In