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Regulation

Set Alert for Regulation

EMA Moves Ahead With Tailored Scientific Advice For Biosimilars

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.

Biosimilars Europe

Central Role For Industry Beckons As Europe Rebuilds After COVID

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.

Policy Regulation

Legal Certainty Needed On Northern Ireland, Industry Insists

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.

Policy Regulation

FDA Will Take Action On Biosimilars Delayed By Inspection Lag

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.

Biosimilars FDA

Will All US Biosimilar mAbs Be Interchangeable In The Long Run?

As Boehringer Ingelheim’s Cyltezo has become the second-ever interchangeable biosimilar approved by the US FDA – as well as the first monoclonal antibody to garner the designation and offering the first published data from a switching trial to support interchangeability – the debate around the potential impact for interchangeable products in the keenly-watched adalimumab space and beyond continues to grow.

Biosimilars Regulation

First Interchangeable Humira Biosimilar Approved In US

Boehringer Ingelheim has won a landmark first US interchangeability designation for a biosimilar to Humira, with the firm’s Cyltezo version of adalimumab representing the second ever interchangeable biosimilar approved by the FDA.

Biosimilars Approvals

EU Revamps Plans To Ease Medicines Trade Between GB and NI

Proposals on medicines put forward by the European Commission are part of a package of measures to improve the implementation of the Northern Ireland Protocol by relaxing checks on goods moving across the Irish sea.

Europe United Kingdom

US FDA Unlikely To Issue Broad Biosimilar Guidance Saying Comparative Clinical Studies Unnecessary

OTBB head Sarah Yim says FDA internal thinking is not aligned on the idea and that a lot of convincing was necessary to drop the clinical study requirement for insulin biosimilars.

Biosimilars Drug Approval Standards

FDA-EMA Pilot Could Further Push Global Generic Harmonization, But Will Sponsors Use It?

Regulators hope parallel scientific advice pilot for complex generics is more popular than brand program was at start; sponsors want use of foreign comparator products and tighter harmonization.

Review Pathway Regulation
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