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Apotex Inc.

www.apotex.com

Latest From Apotex Inc.

FDA Warns Apotex Management To Demand Quality, Meet Specs

Apotex warning letter reflects FDA’s emphasis on company-wide quality systems and invalidated OOS results.

Manufacturing Quality

Biosimilar Litigation Trends: Settlements, Declaratory Judgment Rejections, Congressional Intervention

Of the 27 suits brought so far, four have resulted in patent settlements; restarting patent dance is new trend for ongoing litigation.

Biosimilars Intellectual Property

US FDA’s First Competitive Generic Therapy Approval Comes With A Twist

Apotex’s potassium chloride oral solution is eligible for 180-day exclusivity under new expedited pathway even though Amneal’s generic referencing same product was approved three weeks earlier; Amneal's continued marketing will not be blocked by Apotex’s exclusivity, which is forfeited if it fails to launch within 75 days.

Approvals Generic Drugs

EMA ‘Yes’ For Pegfilgrastim Biosimilars Spells End For Neulasta’s EU Stronghold

Approval of the first pegfilgrastim biosimilars in the EU would mark the start of a period of accelerated sales declines for Amgen's Neulasta but the outlook for the blockbuster bio-originator is not necessarily bleak.

Biosimilars Commercial
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