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 sustainability of the generics industry and undermine the development of biosimilars that play a critical role in access to medicines. It is time to restore […]
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 in development today are biologicals. The complexity of biologicals, the investment needed to meet ever more stringent regulatory and payer requirements, combined with the needs […]
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. Biosimilar patent litigation continues to evolve as biosimilars enter new global markets. This manuscript is the second part of a manuscript that took a look […]
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 innovative pharmacological therapies. In addition, biosimilars, which can be authorized on the date of expiry of a biological originator’s patent, give an opportunity for the […]
