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Interchangeable Biosimilar Approved Without Switching Data; Cimerli To Compete With Lucentis

 
• By Sue Sutter

Citing low risk of a clinically impactful immunogenic response from systemic anti-drug antibodies and intraocular inflammation when alternating between Coherus’ Cimerli and Genentech’s reference product ranibizumab, US FDA says a switching study would not be informative.

Railroad tracks crossing
Coherus avoided having to conduct a study in which patients switched back and forth between Cimerli and the reference product Lucentis. • Source: Shutterstock

The US Food and Drug Administration on 2 August approved Coherus BioSciences, Inc.’s Cimerli (ranibizumab-eqrn) as the first interchangeable biosimilar to Genentech, Inc.’s age-related macular degeneration treatment Lucentis, without the need for a “switching” study.

Cimerli is approved for all five of Lucentis’ indications: neovascular (wet) AMD; macular edema following retinal vein occlusion; diabetic macular...

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New EU Filings

 
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Japan Roundup: Approvals Recommended For Ibtrozi, Voranigo And Ycanth

 
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First-Of-A-Kind Nasal Spray For Pain In Children Among 13 New EU Filings

 
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• By Derrick Gingery

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