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Biosimilars & Generics

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Italy Probes Alleged Antitrust Deal Over Biosimilar Version Of Eye Drug Lucentis

Did Samsung Bioepis and Biogen choose early US access for their Lucentis biosimilar in exchange for postponing launch in other markets? That’s what Italy’s competition authority believes, as it investigates the biosimilar sponsors and originator companies Genentech and Novartis.

Regulation Legal Issues

US FDA’s Yim Hints At Revisiting Biosimilar Suffix Naming Convention, Reassures On Immunogenicity

In an ‘ask me anything’ Q&A on Reddit, Sarah Yim, director of US FDA’s Office of Therapeutic Biologics and Biosimilars, offered some insights on the US biologics naming convention, biosimilar interchangeability, and the possibility of future competition on cell and gene therapies.

Biosimilars Review Pathway

ANDA Suitability Petitions: The Timelines They Are A-Changin'

US suitability petition submissions see an uptick against the backdrop of GDUFA III new goals for the FDA's response to such petitions. The Pink Sheet tracks some of the activity as applicants seek to tap market opportunities without the need for new clinical data.

Regulation Generic Drugs

Former Sandoz Exec Kellum Avoids Jail Time Over US Price Fixing

Four years after pleading guilty plea generic price-fixing allegations, the former Sandoz US vice-president of business contracting and analytics, Hector Armando Kellum, will serve his sentence outside a jail cell and pay a fine.

Legal Issues Generic Drugs

Brand Drug Shortages Complicate US FDA Messaging To Congress

The US FDA is eager for Congress to address critical factors contributing to chronic generic drug shortages, but elected officials often are more focused on special cases like obesity drugs and ADHD treatment where the answers are very different. 

Generic Drugs Manufacturing

US Appeals Court Backs Dismissal Of Bystolic ‘Pay-For-Delay’ Case

The US Court of Appeals for the Second Circuit afirmed a US district court decision to dismiss purchaser and payer claims linked to so-called “pay-for-delay” agreements with generics firms over nebivolol rivals to Bystolic.

Generic Drugs Legal Issues

US FDA Transparency Win: Sponsors Know More Product-Specific Guidances Coming, Requests Fall

After creating a list of anticipated product-specific guidances to be published for generic sponsors and increasing PSG production, public requests for the agency to write a PSG declined.

Generic Drugs Guidance Documents

Pink Sheet Podcast: US FDA Adcomm Reform, Clinical Trial Modeling Boost, AI For Drug Review

Pink Sheet reporter and editors discuss what an upcoming listening session means for the FDA’s advisory committee reform effort, the agency’s efforts to help clinical trial modeling and simulation, and the UK’s MHRA plan to use artificial intelligence to assist in drug reviews.

Advisory Committees Clinical Trials

EU Urban Wastewater Directive Update ‘Unfairly Targets Pharmaceutical Industry’

The European Parliament has voted for a deal agreed with the council of ministers to ensure polluters pay for cleaning up urban wastewater.

Europe Germany

US FDA Developing Model Master File System To Grow Modeling, Simulation Field

Similar to drug master files, MMFs would allow models to be reused, but critical issues, such as protection of proprietary information, still must be resolved.

Artificial Intelligence Clinical Trials

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

Pink Sheet Podcast: US FDA Biosimilar Strategy, Gene Therapy Accelerated Approvals, FDA v. Partisan Politics

Pink Sheet reporter and editors discuss the impact of FDA biosimilar promotion guidance on the future of the interchangeability designation, upcoming guidance on accelerated approval for gene therapies, and partisan attacks on the agency from Capitol Hill.

Biosimilars Gene Therapy

Mary Beth Clarke, CDER Exec Programs Office Director And Generic User Fee Shepherd, Will Retire

Clarke helped launch GDUFA I and negotiate GDUFA II, chaired the CDER Executive Committee and oversaw many other programs in the US FDA’s drugs center.

FDA Leadership

Rx Advertising: Interchangeability Doesn’t Mean Clinical Superiority To Other Biosimilars, FDA Says

Updated draft guidance on promotion of biologic reference products, biosimilars and interchangeable biosimilars offers another indication of the US’s push to do away with the interchangeability designation.

Advertising, Marketing & Sales Biosimilars

Generic Or Innovator? Sandoz Sues CMS Over Potential Change In Rebate Classification

Sandoz argued against paying higher rebates for two of its drugs via the Centers for Medicare and Medicaid Services’ Medicaid drug rebate program in a US court six years after the suggestion was first made.

Generic Drugs Legal Issues

Parallel Scientific Advice: Is The EMA User Fee Impacting Interest?

EMA charges participants to receive scientific advice through the fledgling program, unlike the US FDA, which may not fit the budgets of some complex generic sponsors. At the same time, sponsors also may simply not be aware the program exists yet.

Generic Drugs Regional Comparisons
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