Legal
Policy recommendations for a sustainable biosimilars market: lessons from Europe
Author(s): Michael S Reilly, Esq, Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP
Page: 76-83
Author byline as per print journal: Professor Philip J Schneider1, MS, FASHP, FASPEN, FFIP; Michael S Reilly2, Esq Abstract: Approximately 25% of all new medicines approved in recent years and… Read More »
It is time to change US trade policy to foster access to medicines
Abstract: While Americans are deeply concerned about drug prices, the United States Trade Representative (USTR) continues to negotiate agreements like the United States-Mexico-Canada Agreement (USMCA) that put at risk the… Read More »
Biosimilars: considerations in light of the Italian legal framework
Author(s): Enrico Adriano Raffaelli, LLB, JD, Fausto Massimino, LLB, JD
Page: 5-23
Abstract: Biological and biotechnological medicines are important pharmaceutical innovations due to their influence on the treatment of many conditions and because they have led the way in devising new and… Read More »
Biosimilars patent litigation in Canada and Japan: a comparative strategic overview and EU and US update
Abstract: Biosimilars are highly similar versions of reference biological products, some with the potential to be deemed ‘interchangeable’ by medicines regulatory bodies, such as the US Food and Drug Administration.… Read More »