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Sandoz's Multi-Switch Biosimilar Trials: A View To Interchangeability?

 
• By Derrick Gingery

Company's application development seems to be outpacing FDA's policy development in next step along the 351(k) pathway.

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Sandoz Inc.'s application package for its biosimilar to Amgen Inc.'s Enbrel continues to signal to FDA that the company is ready to move forward on interchangeability even if the agency is not.

A clinical study with multiple switches between GP2015 and its reference product was part of Sandoz's application to determine it...

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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.

More from Biosimilars & Generics

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.