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Biosimilar Guidance Development Timelines Criticized By Docs And Patients

 
• By Sue Sutter

FDA's user fee deal with sponsors sets target dates for documents on interchangeability, naming and labeling, but non-industry stakeholders urge agency to accelerate their release; guidance development efforts will get boost in BsUFA II with funding for new dedicated biosimilars unit starting in fiscal year 2018.

FDA entrance sign 2016

The FDA/industry-negotiated agreement to renew the biosimilar user fee program provides too much lag time for issuing and finalizing key guidance documents, representatives from consumer and professional groups said at an Oct. 20 meeting.

However, the agreement’s target dates for a long-delayed draft guidance on interchangeability, and final guidance documents on nonproprietary naming and...

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EU Biosimilar Filings, Opinions And Approvals

 
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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.

Korea’s New Health Minister: ‘Golden Time For The Country To Become A Biopharma Leader’

 
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Multiple Korean ministries, biopharma companies, and other officials convened at a bio innovation roundtable to discuss strategies to emerge as a global biopharma powerhouse.

US FDA Upheaval Forces User Fee Talks To Begin Later Than Usual

 
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The fall start of PDUFA and GDUFA negotiations could impact the agreement review process and other parts of the schedule intended to ensure it reaches Congress on time.

Off-Patent Drugs Get UK Spotlight, But Picture Is Still ‘Nuanced’

 
• By Urtė Fultinavičiūtė

The importance of generic and biosimilar medicines is being recognized by the UK government for the first time. However, Mark Samuels, CEO of Medicines UK, the trade body representing the off-patent industry, says companies are still face multiple hurdles in the market.

More from Biosimilars & Generics

US FDA Gives Leucovorin Unprecedented Path To New Claim Amid ‘Autism Crisis’

 
• By Bridget Silverman

The Trump Administration's autism campaign convinced GSK to submit an sNDA for its no-longer-marketed leucovorin as a treatment for a rare folate deficiency condition with promises to ensure insurance coverage for autism.

Korea’s New Health Minister: ‘Golden Time For The Country To Become A Biopharma Leader’

 
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Multiple Korean ministries, biopharma companies, and other officials convened at a bio innovation roundtable to discuss strategies to emerge as a global biopharma powerhouse.

Swissmedic Slashes Months Off Review Time For Certain Drug Filings

 
• By Anabel Costa-Ferreira

Switzerland’s health care products agency said it had cut the time it takes to review marketing applications for certain drugs submitted via its regulatory reliance procedure because it wants to further enhance the appeal of the pathway.