Latest From Apotex Inc.
Apotex warning letter reflects FDA’s emphasis on company-wide quality systems and invalidated OOS results.
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.
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.
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.
- Generic Drugs
- Therapeutic Areas
- North America
- Parent & Subsidiaries
- Apotex Inc.
- Senior Management
- Jeremy B Desai, PhD, Pres. & CEO
- Contact Info
Phone: (800) 268-4623
150 Signet Dr.
Toronto, M9L IT9
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