A European Medicines Agency pilot scheme offering tailored scientific advice on biosimilar development has been viewed by applicants as a “valuable opportunity” and the process will continue as part of regular operations, according to an agency report.

A European Medicines Agency pilot scheme offering tailored scientific advice on biosimilar development has been viewed by applicants as a “valuable opportunity” and the process will continue as part of regular operations, according to an agency report.

Generic and biosimilar medicines must become central to European healthcare policy as the region looks to rebuild in the wake of the COVID-19 pandemic, Medicines for Europe’s new president, Rebecca Guntern of Sandoz, tells Generics Bulletin in an exclusive interview.

After 180 Life Sciences recently struck a deal with Korea’s Celltrion to support its work in repurposing off-patent biologics, CEO Jim Woody speaks to Generics Bulletin about what the collaboration means for the company and its next steps.

A continuing lack of legal certainty continues to plague suppliers to the Northern Ireland market despite the latest proposals from the EU Commission, UK and European off-patent industry leaders Mark Samuels and Adrian van den Hoven tell Generics Bulletin.

With multiple US biosimilar applications held up by the FDA’s inability to conduct necessary inspections in the context of the COVID-19 pandemic, the agency tells Generics Bulletin that it is “actively working” on a solution.