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Apotex Inc.

www.apotex.com

Latest From Apotex Inc.

Keeping Track: A Diverse Array Of Approvals, A CRL For Evolus' Botox Competitor, And Coherus Refiles Neulasta Biosimilar

The latest drug development news and highlights from our US FDA Performance Tracker.
Drug Review Regulation

Keeping Track: FDA Delays Elagolix, Mylan Eyes For Neulasta Biosimilar Approval, And Duvelisib Gets Priority Review

The latest drug development news and highlights from our US FDA Performance Tracker.

Biosimilars Drug Review

Mylan Poised To Launch Its First US Biosimilar, With A Stacked Pipeline Behind It

A biosimilar of Amgen's Neulasta appears on track for FDA approval by the June 4 action date, management said during an investor briefing that showcased Mylan's expansive biosimilar pipeline. Mid- to late-stage copies of products like Advair, Symbicort, Herceptin, Humira, Avastin, Rituxan, Eylea and Botox highlight the strategic direction Mylan moved in nearly a decade ago. 

Biosimilars Generic Drugs

Australian Court Restrains Apotex Challenge To Cipla-Meda’s Dymista

Apotex’s plans to launch a nasal spray formulation that competes with Cipla-Meda’s Dymista has been blocked by the Federal Court of Australia, at least for now. Apotex has challenged the validity of certain claims of the patent pertaining to Dymista.

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