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Sandoz Inc.

Division of Novartis AG
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Latest From Sandoz Inc.

Lupin’s Karkaria Addresses Biosimilars Pushback

Lupin's biotech president notes push-back by innovator firms against biosimilars in the US parallels that witnessed when small molecule generic competition first emerged, but remains confident that biosimilars will gain traction. The executive also sees little need for separate interchangeability studies.

Biosimilars Strategy

Lupin’s Karkaria On Biosimilars Pushback And Interchangeability

Lupin's biotech president notes push-back by innovator firms against biosimilars in the US parallels that witnessed when small molecule generic competition first emerged, but remains confident that biosimilars will gain traction. The executive also sees little need for separate interchangeability studies.

 

Commercial Strategy

FDA's Stein Sees Differences On Biosimilar Review

US FDA's Office of New Drugs director Peter Stein explained that different review divisions take different approaches in their regulation of biosimilars, but feels their frameworks will become more unified as they gain experience in reviewing biosimilar programs.

Biosimilars Regulation

US FDA's Stein: 'Cognitive Dissonance' Exists Between Review Divisions In Regulation Of Biosimilars

US FDA's Office of New Drugs director Peter Stein explained that different review divisions take different approaches in their regulation of biosimilars, but feels their frameworks will become more unified as they gain experience in reviewing biosimilar programs.

Biosimilars Drug Approval Standards
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