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.
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Revised draft guidance suggests greater openness to alternative methods and scales for measuring adhesion, but agency sticks with 15% non-inferiority margin despite manufacturer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.
- Generic Drugs
- Therapeutic Areas
- North America
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- Apotex Inc.
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- Jeremy B Desai, PhD, Pres. & CEO
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Phone: (800) 268-4623
150 Signet Dr.
Toronto, M9L IT9
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