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Biosimilars & Generics

Set Alert for Biosimilars & Generics

EU Legislators Firm Up Commission’s Plans To Overhaul Pharma Rules

Efforts to overhaul the EU pharmaceutical legislation have been given added impetus after the European Parliament called for action to boost innovation and medicines access, shore up manufacturing and supply chains, and examine the link between R&D spending and drug prices.

Europe Legislation

Health Canada Ponders UK Model On Easing Biosimilar Study Requirements

Discussions are ongoing at Health Canada on the feasibility of adopting the UK model of easing clinical study requirements for biosimilars, said director general Celia Lourenco at a recent event. Meanwhile, the US FDA’s stance is unchanged for now.

Regulation Biosimilars

Growing Complex Generic Application Load May Force US FDA Staffing Changes

Complex products are slowly gaining a larger share of ANDA submission and approval totals, which could mean the FDA has to adapt its in-house expertise to compensate.

Generic Drugs Review Pathway

Former Generic Industry Exec Who Went Undercover For DOJ No Longer Debarred

US FDA chief scientist said former exec, who was part of the generic drug scandal, deserves special termination of 1993 debarment due to his 'substantial assistance' to the DOJ in its investigations of others. Office of Regulatory Affairs wanted to deny his petition.

Generic Drugs Enforcement

Strange Bedfellows: Generics Firms Join Big Pharma In Opposing Price Negotiation Legislation

Concerns that Medicare drug price negotiation provisions in the Build Back Better legislation would upend the generic and biosimilar industries might resonate with legislators more than complaints from branded drug companies.

Pricing Debate Legislation

US FDA Pandemic Performance: On-Time Decision Rates Improve; COVID Applications, Supplements Drop

Biosimilars continue their erratic behavior, with the low numbers driving big swings.

Coronavirus COVID-19 Drug Review

Belgian Court Backs Generic Clawback Exemption Against Brand Industry Challenge

Belgian off-patent industry association Medaxes has welcomed a court decision to reject a brand industry challenge over the exemption of generics from the country’s pharmaceutical clawback tax.

Belgium Legal Issues

BsUFA III Meeting Improvements To Cut Requests, Improve Biosimilar Development Efficiency

New biosimilar Type 2a meeting will facilitate faster development, stakeholders said, but one representative also warned that the inspection backlog must be eliminated in order for the US FDA to meet the new user fee program commitments.

Biosimilars User Fees

GDUFA III: Convening Enhanced Mid-Cycle Meeting Will Cost Sponsors

Requesting the new meeting type for an ANDA assessment will trigger a goal date extension with another possible should an unsolicited application amendment also be necessary.

Generic Drugs User Fees

GDUFA III Agreement Will Constrain Fee Revenue Increases

Generic user fee program's next iteration will also offer improved mid- and post-assessment communications for sponsors to receive feedback from US FDA.

Generic Drugs User Fees

Industry Leaders Call For Legal Certainty On Northern Ireland Regulation

The European Commission’s proposals for solving the post-Brexit regulatory problems relating to the Northern Ireland market are welcome but they do not go far enough and risk leaving suppliers in a legal limbo, says the off-patent medicines industry.

Europe United Kingdom

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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