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Side Step-Wise Development: Sponsors Aren’t Using FDA’s Preferred Approach To Biosimilars

 
• By Derrick Gingery

Rather than conduct most analytical characterization and non-clinical studies first, the hallmark of the US FDA approach, biosimilar sponsors are often initiating clinical trials about the same time.

Steps
The approach is not working from a 'chronological' standpoint, Sarah Yim said. • Source: Shutterstock

After more than a decade, the US FDA’s vaunted step-wise approach to biosimilar development is not being used as intended, which may be hindering the sector’s growth and limiting pricing pressure on originator biologics.

The FDA wants biosimilar sponsors to analytically characterize their biosimilar candidates before conducting clinical trials, which can help eliminate uncertainty...

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Biogenerics After All? US FDA Wants Biosimilar Process To Mirror Generics

 
• By Ramsey Baghdadi

US FDA’s new top drug regulator is promising to update regulatory standards for biosimilars to make the process look more like the generic drug pathway, where ‘we just characterize the molecule.’ Advancements in characterization are driving the ‘analytical revolution.’

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.

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

 
• By Jung Won Shin

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

 
• By Derrick Gingery

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.

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How Will Trump’s Visa Brick, Rubio’s Tariff Fix, Lower Domestic Tax Impact Indian Pharma?

 
• By Vibha Ravi

As US Secretary of State Marco Rubio hints at reconsideration of a punitive Russian oil tariff, Trump adds an H-1B visa brick to his trade wall and India lowers GST on cancer and rare disease drugs, the Pink Sheet considers the impact.

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’

 
• By Jung Won Shin

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