Biologics

WHO Meeting Looks Forward on Distinguishable Names

October 20, 2016

This month’s World Health Organization Open Sessions with INN Stakeholders explored the value, and the future, of the biological qualifier system. The Global Alliance for Patient Access was pleased to present to WHO officials and an international group of fellow stakeholders.

GAfPA “NOR-SWITCH” Paper Explores Impact of Biosimilar Switching Research

September 15, 2016

Data from a clinical study in Norway may soon explain the effects of switching stable patients from a biologic medicine, infliximab, to its biosimilar counterpart. But, as the Global Alliance for Patient Access argues in a new white paper, policymakers must accurately interpret what the NOR-SWITCH study will – and will not – demonstrate about the safety of switching.

FDA Hearings Underscore Need for Clear Policy on Biosimilars

July 20, 2016

July 12 and 13 hearings of the FDA’s Arthritis Advisory Committee cleared the way for two new biosimilars, adalimumab and etanercept. The committee unanimously supported manufacturers’ applications for the drugs – but that wasn’t the only point of consensus. Participants and even committee members expressed concerns about unfinished regulatory policy and the need to prioritize patient safety.