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Apotex Inc.

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Latest From Apotex Inc.

Mylan’s Fulphila: First Neulasta Biosimilar’s Road To US Market Slowed Only By Product Quality, GMP Deficiencies

Mylan demonstrated analytical similarity, including for the PEG moiety, and the absence of clinically meaningful differences between MYL-1401H and Amgen’s pegfilgrastim during first review cycle, but it had to resubmit the application after FDA flagged concerns about the biosimilar’s manufacturing process and ongoing facility deficiencies.

Drug Review Profile Biosimilars

Lack Of Priority? No ANDAs Approved Using Expedited Pathway In FY 2018

US FDA also refused to receive many priority generic drug applications, suggesting the expedited pathway may not be working as intended quite yet.
Generic Drugs Review Pathway

Keeping Track: FDA Starts November With A Bang

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

Complex Generics: US FDA Heeds Some, But Not All, Of Industry’s Calls For Flexibility On Transdermal Products

Revised draft guidance suggests greater openness to alternative methods and scales for measuring adhesion, but agency sticks with 15% non-inferiority margin despite manufacturer objections; FDA also releases new guidance on assessing irritation and sensitization potential with topical delivery system products.

Drug Delivery Drug Approval Standards
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