Biosimilars & Generics

Dickinson, who joined the Office of Chief Counsel in 1994, retired on 24 September. Former colleagues note the impact she had within and outside the agency, particularly as the ‘legendary leader’ of the legal approach to generic drugs.

Susan Rosencrance, who helped negotiate GDUFA III, will take over as acting director of the Office of Generic Drugs following Sally Choe’s departure on 8 October. Former OGD head Uhl says the director needs to be the ‘number one advocate for the generic drug program inside the agency.’

US FDA India country director Dr Sarah McMullen provides a fact check at a recent conclave to dispel the notion that interchangeable biosimilars are safer and more effective than other approved biosimilars.

Pink Sheet reporters and editor discuss the impact of the long wait for a user fee deal to be negotiated, how the FDA will interpret President Biden’s statement that the COVID-19 pandemic is over, and concerns with the clinical development of the monkeypox treatment Tpoxx.

The FDA had picked grantees for the initial round of biosimilar regulatory science research, but told them not to start major activities until the user fee reauthorization was assured. Congress now appears to have reached deal for a ‘practically clean’ reauthorization.

A joint statement from the European Medicines Agency and Heads of Medicines Agencies on biosimilar interchangeability is “concerning,” says Europe’s R&D-based industry federation, EFPIA.

Increases in approved ANDAs that were affected by GDUFA research shows the importance of the US FDA’s regulatory science program.

Pharmaceutical industry groups pushed back on expansion beyond CARES Act requirements that agency proposed in draft guidance, saying it would increase the risk of drug shortages instead of reducing it. One group went further, objecting to cGMP regulatory creep into the supply chain.

The European Commission has laid out a number of possibilities for changing the EU framework on compulsory licensing to improve the availability of products in health emergencies. The options include extending the scope of compulsory licences beyond patents to other forms of protection such as data exclusivity.

OTBB Director Sarah Yim tells the Pink Sheet that FDA cannot make an official determination that biosimilar-to-biosimilar switches are acceptable, but the agency does think about how a product will be used in the market while assessing the application.

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

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.