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Sandoz Inc.

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Latest From Sandoz Inc.

Sandoz Defeat On Amgen’s Otezla Pushes US Generic Opportunity Back To 2028

Amgen is set to enjoy its monopoly on the Otezla oral treatment for plaque psoriasis until late into the decade, after ANDA sponsors Sandoz and Zydus Cadila failed to find a way around the originator’s intellectual property, including a key patent expiring early in 2028.

Companies Generic Drugs

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
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