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US FDA’s Byooviz Review By The Numbers

 
• By Sue Sutter

A timeline of the development and approval of Samsung Bioepis’ Byooviz, a biosimilar to Genentech’s Lucentis, and a listing of FDA reviewers on the biologics license application.

Drug Review Profile: Byooviz Chronology
Byooviz was the first biosimilar to Lucentis approved in the US. • Source: Shutterstock/Alamy

Elsewhere in this Drug Review Profile, the Pink Sheet examines how Samsung Bioepis Co., Ltd. and Coherus BioSciences, Inc./Bioeq IP AG, sponsors of biosimilar versions of Genentech, Inc.’s macular degeneration drug Lucentis, had to navigate different expectations from the US Food and Drug Administration and European Medicines Agency. (Also see "Biosimilar Lucentis Sponsors Had To Navigate Different FDA, EMA Requirements" - Pink Sheet, 1 September, 2022.)

This Drug Review Profile also looks at how the FDA justified an interchangeability determination for Coherus’ Cimerli (ranibizumab-eqrn) in the absence of data from a "switching" study

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EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

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.

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By Dave Wallace

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.

Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 
• By Derrick Gingery

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.

Biosimilars Industry Celebrates EMA’s Plan to Reduce Clinical Trials

 
• By Dave Wallace

The European Medicines Agency’s latest move towards a more streamlined process for biosimilar registration in Europe was the hottest topic at last week’s annual biosimilars conference held by Medicines for Europe in Amsterdam.

More from Biosimilars & Generics

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

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.

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By Dave Wallace

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.

Beyond Tariffs: The Silver Lining Of The US Pharma Security Investigation

 
• By Jessica Merrill

An investigation by the US Secretary of Commerce into pharmaceutical imports gives industry an opportunity to comment. AAM CEO John Murphy talked to Pink Sheet's sister publication Scrip about the latest developments.