BPCIA's disclosure requirements under 42 U.S.C. Section 262(l)(2)(A) not enforceable by injunction; applicant seeking FDA approval for biosimilar product need not wait for licensure before providing commercial marketing notice.
To continue reading, please subscribe.
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!
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!
Already a subscriber?
Sign In