Legal

Among the briefs filed in defense of the Affordable Care Act and, with it, the Biologics Price Competition and Innovation Act (BPCIA), is one from the Association for Accessible Medicines, which argues the BPCIA is vital to biosimilars market development.
Australia’s secretive drug approval system gives what some believe is an unfair advantage to rival drug companies.
 
Trying to carve back its market share for Neupogen, its filgrastim originator product, Amgen is hoping product exclusivity can be backdated.
European investigators say their analysis of court cases involving innovator monoclonal antibodies suggests secondary patents have generally failed to stop biosimilar competition.
Taking an abundance of time to file a motion to block Kanjinti from coming to market, Genentech unwittingly may have tipped the scales in favor of biosimilar applicants.
 
Ha Kung Wong, JD, a patent law attorney with Venable of New York, New York, discusses recent regulatory actions to promote biosimilars.
The Center for Biosimilars® recaps the top stories for the week of March 30, 2020.
Life under the new biologics pathway will be easier for some drugs than others, notes Stacie L. Ropka, PhD, JD, a patent attorney with Axinn, Veltrop & Harkrider LLP, in Hartford, Connecticut.
Seen up close, many patents are not truly strong enough to block biosimilar commercialization, although patents filed after FDA approval of originator products can bar access to modern manufacturing methods, according to Hans Sauer, deputy general counsel and vice president for intellectual property at the Biotechnology Innovation Organization (BIO).
The Supreme Court will hear an appeal by a coalition of 20 mainly Democratic states, which are hoping for a reversal of a Fifth Circuit Court of Appeals ruling that held the Affordable Care Act’s (ACA) individual mandate is unconstitutional and called into question whether the remaining provisions of the law could still stand. However, a decision will not come until after the November 2020 presidential election.

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