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Biosimilars & Generics

Set Alert for Biosimilars & Generics

Former FDA Chief Counsel Elizabeth Dickinson Hailed For Her Expertise, Warmth And Mentorship

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.

FDA Legal Issues

Next US FDA Generics Leader Must Have ‘Frank Conversations’ With Colleagues, Industry, Former OGD Director Says

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.’

Generic Drugs Leadership

'Incorrect' To Assume Interchangeables Are Safer, More Effective Than Biosimilars, Says FDA

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.

Biosimilars Drug Safety

Pink Sheet Podcast: Finally, A US FDA User Fee Deal, ‘Pandemic Is Over’ Take-Aways, Tpoxx Development Issues

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.

User Fees Coronavirus COVID-19

Will US FDA User Fee Deal Allow BsUFA Reg Science Research To Start?

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.

Biosimilars User Fees

R&D Industry Finds Biosimilar Interchangeability Statement By EU Regulators ‘Concerning’

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.

Europe Biologics

GDUFA Research Impacting Generic Development, ANDA Approvals

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

Generic Drugs Research & Development

Industry Calls For Narrower, More Flexible Supply Risk Planning Program Than US FDA Proposed

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.

Manufacturing Supply Chain

EU Gears Up For Compulsory Licensing Reform

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.

Europe Intellectual Property

Concern Over Biosimilar-To-Biosimilar Switch Could Impact Approval, US FDA Official Says

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.

Biosimilars Review Pathway

Keeping Track: US FDA Novel Approvals Return With Xenpozyme, Spevigo Nods; Stimufend Survives COVID-19 Delays

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

US FDA Performance Tracker Drug Review

EU Biosimilar Filings, Opinions And Approvals

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.

Europe Approvals
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