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Biosimilars & Generics

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EU Committee Backs Collective Drug Price Talks, Early-Warning System For Shortages

A report beefing up the proposals contained in the European Commission’s Pharmaceutical Strategy has been approved by an influential parliamentary committee that wants to see a “stable, updated and safety-centered regulatory system” and an "autonomous and resilient" pharmaceutical industry.

Europe Regulation

Could Sponsors’ Supply Chain Policing Have Caught Alleged CRO Fraud?

The US FDA always encourages sponsors to ensure their suppliers and contractors are following the law, but agency inspectors may have been the only ones who could have discovered the data integrity problems that forced the downgrading of more than 100 generic drug applications.

Generic Drugs Research & Development

More Than 100 Applications Lost Equivalence Rating Thanks To Allegedly Falsified Data At Two CROs

Sponsors must decide whether to repeat bioequivalence and other studies after two CROs were found to have potentially falsified data, causing the US FDA to reject all data produced by the firms.

Generic Drugs Compliance

Medicines Patent Pool Welcomes WHO’s Updated Essential Medicines List

The World Health Organization’s updated essential medicines list includes four medicines already licensed to the Medicines Patent Pool, of which two were developed through MPP licensees. The WHO’s updated list includes SGLT2 inhibitors – oral medications used to lower blood glucose levels – for which the MPP and the International Diabetes Federation have committed to improve affordable access in low- and middle-income countries.

International Market Access

US FDA Unlikely To Issue Broad Biosimilar Guidance Saying Comparative Clinical Studies Unnecessary

OTBB head Sarah Yim says FDA internal thinking is not aligned on the idea and that a lot of convincing was necessary to drop the clinical study requirement for insulin biosimilars.

Biosimilars Drug Approval Standards

Generic Entry Reforms Gain Steam In Congress With House Committee Passage

Bills to reign in petitions, pay-for-delay, product hopping, and patent thickets clear House Judiciary Committee. Legislation may have better shot at enactment this time around given bipartisan support in both House and Senate Committees.

Intellectual Property Legislation

European Commission Steps Further Towards ‘Ambitious’ Pharma Legislation Reform

The incentives system, access to medicines, future proofing for novel products and antimicrobial resistance are just some of the topics included in a new consultation.

Europe Biosimilars

Real-World Evidence Under Consideration For Use In Interchangeable Biosimilars Applications

US FDA research funded under BSUFA III will investigate what kind of safety data is needed for interchangeability. A demonstration project aimed at improving biosimilar product development efficiency and enhanced regulatory decision-making also will be part of the new regulatory science research program.

Biosimilars User Fees

BsUFA III Expands Biosimilar Supplement Review Goals To Speed Approvals

Six supplement categories based on submission content will be created with review goals between three and 10 months.

User Fees Biosimilars

Generic Drugs: ‘Competitive’ Exclusivity Benefited Few Sponsors But Is Increasingly Popular

The six months of additional exclusivity from US FDA’s CGT program appears to have kept some generic sponsors from the market, and didn’t even prompt others to enter quickly, but use of the competitive generic exclusivity program continues to grow.

Generic Drugs Intellectual Property

US FDA’s Patent ‘Concerns’ Include Thickets, Product Hopping, And Evergreening

Senators press for sharing of FDA applications with PTO as Woodcock letter seeks collaboration on everything from PTAB to patent term extensions to ‘possible misuse of the patent system.’

Intellectual Property Generic Drugs

ANDA Guidance Says Yes To Limited Stability Data, No To Expired Reference Product During COVID

US FDA's updated Q&A guidance on developing generics for submission via the abbreviated new drug application pathway during the COVID-19 pandemic has been published.

Generic Drugs Coronavirus COVID-19
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