Generics Bulletin is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Regulation

Set Alert for Regulation

EMA Clarifies Questions Over Biosimilar Interchangeability

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.

Biosimilars Regulation

Teva Concedes On US Gimoti ANDA, Voiding 180-Day Exclusivity

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.

Generic Drugs Intellectual Property

BsUFA Research Roadmap Highlights Interchangeability And Reducing Trials

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.

Biologics Regulation

IGBA Struggles To Find Data On Global Drug Shortages For WHO

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

International Supply Chain

Industry Warns Of New Post-Brexit ‘Cliff Edge’ For Medicines Supply To Northern Ireland

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.

United Kingdom Europe

German Generic Reform To Relax Pediatric Pricing

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

Germany Generic Drugs

Biosimilars Forum Urges Equal Access For US Humira Rivals

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.

Biosimilars United States

A Bad Fit: Dan Leonard’s Leadership Style Did Not Translate At AAM

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.

Leadership United States

Coherus Files On-Body Pegfilgrastim, Says ‘People Talk’ On Potential Rivals

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.

Biosimilars Regulation
See All
UsernamePublicRestriction

Register