February 13th 2018
By Samantha DiGrande
Yesterday, President Trump released his budget proposal for the 2019 fiscal year. On the same day, the Proceedings of the National Academy of Sciences of the United States of America released a paper summarizing the NIH’s contribution of funding to new drugs approved from 2010 to 2016.
November 29th 2017
Robert Cerwinski, JD, partner at Goodwin, discusses the challenges that reference product sponsors encounter when they also seek to develop biosimilars.
October 19th 2017
By The Center for Biosimilars Staff
SPCs are an intellectual property right that grants an extension of up to 5 years on a 20-year patent term for an innovative pharmaceutical. The goal of the SPC is to offset the loss of patent protection that occurs during the development and clinical trials of a generic or biosimilar.
August 18th 2017
By Kelly Davio
A recent paper, published in BioDrugs, argues that, in biosimilar development, bridging studies between locally licensed and internationally licensed reference biologics may be unnecessary.
August 4th 2017
By Jackie Syrop
The development of biosimilars is focused on the minimization of potential differences between the proposed biosimilar and reference product, as well as the establishment of a robust manufacturing process to consistently produce a high-quality biosimilar.
