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Sandoz Inc.

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Latest From Sandoz Inc.

FDA Official Foresees Reduced Biosimilar Data Burden

New guidance from UK's MHRA saying comparative clinical efficacy studies typically will not be needed is a start, but other regulators may need a few years before adopting similar rules.

Biosimilars Drug Approval Standards

Bio-Thera Follows Hikma Deal With Sandoz Bevacizumab Alliance

Sandoz has plugged another gap in its off-patent oncology pipeline, from which the company has rolled-out four marketed oncology biosimilars, by bringing in Bio-Thera Solutions’ BAT1706 proposed biosimilar to Avastin, including in the US and Europe.

Biosimilars Commercial

Biosimilars: Deep Product Understanding Will Move Regulators To Reduce Clinical Data Requirements, US FDA Official Says

New guidance from UK's MHRA saying comparative clinical efficacy studies typically will not be needed is a start, but other regulators may need a few years before adopting similar rules.

Biosimilars Drug Approval Standards

Are Regeneron And Pfizer/BioNTech COVID-19 Products Covered By Patent Safe Harbor?

Allele claims Regeneron’s monoclonal antibody cocktail and Pfizer/BioNTech’s COVID-19 vaccine infringe its fluorescent protein patent. Regeneron asks court to toss suit against it, arguing use of protein for FDA submission is protected. A different court denied Pfizer/BioNTech’s motion to dismiss similar suit.

Intellectual Property Legal Issues
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