Regulation

Responding to questions seeking clarifications over a statement on the scientific rationale supporting the interchangeability of biosimilars in the EU, the EMA has issued a supplementary Q&A document to address issues around multiple switches, complexity of molecular structure and national switching policies.

Teva will not engage in paragraph IV patent-infringement litigation with Evoke Pharma over the originator’s Gimoti (metoclopramide) nasal spray treatment for diabetic gastroparesis, following a court order.

The FDA has published a “Research Roadmap” setting out in detail its areas of interest for the agency’s biosimilar regulatory science pilot program under BsUFA III.

An IGBA research report suggests international health bodies lack an accurate picture of global essential medicines shortages due to issues with monitoring and recording.

The burden of having to produce separate product packs for Great Britain and Northern Ireland is among a number of concerns raised by industry executives at a recent hearing in the House of Lords.

Germany’s Bundesministerium für Gesundheit is reworking the country’s off-patent drug legislation to allow for more flexible pricing.

With the US on the cusp of biosimilar competition to Humira, Julie Reed – executive director of the country’s Biosimilars Forum – has urged PBMs to bolster access by making all adalimumab biosimilars available as they launch throughout 2023.

Former employees at the Association for Accessible Medicines detail problems that emerged during Leonard’s tenure, but also say the board of directors must improve its management of the trade organization.

Having previously underlined that it would not tell the market the exact moment it filed its proposed biosimilar pegfilgrastim on-body injector device, Coherus BioSciences has now confirmed a filing was completed late last year.