Sandoz-led review of 90 published studies finds no evidence to support theoretical concern about differences in immunogenicity when switching between reference biologics and their biosimilars; findings could instill more public confidence about biosimilars in US and reduce importance of an interchangeability designation from FDA.
A new Sandoz Inc.-led literature review finding a lack of adverse effects from switching between a reference biologic and a biosimilar could reduce the importance of an interchangeability designation from the US FDA.
The act of switching between innovator biologics and their biosimilars has not been associated with altered immunologic response, efficacy or safety concerns, according to a systematic review of
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.
Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.
The European Medicines Agency’s latest move towards a more streamlined process for biosimilar registration in Europe was the hottest topic at last week’s annual biosimilars conference held by Medicines for Europe in Amsterdam.
