Latest From Apotex Inc.
Federal appeals court affirms ruling that Apotex's biosimilars do not infringe Amgen's manufacturing process patent, but its applications have stalled at FDA for the past three years.
Janssen concludes the manufacturing processes for Renflexis do not infringe its Remicade patents, clearing Samsung and partner Merck from potential damages resulting from their at-risk launch of the biosimilar; innovator's legal action remains against Inflectra partners Pfizer and Celltrion.
Manufacturers should create internal databases on elemental impurities for product risk assessments and not depend on suppliers to provide this information, which is called for under ICH Q3D. So far risk assessments have shown that most products are significantly below elemental impurity thresholds. Pharmaceutical manufacturers must complete assessments of legacy drugs by Dec. 31.
The EMA’s scientific committee, the CHMP, now has four biosimilar versions of Amgen’s neutropenia drug Neulasta (pegfilgrastim) under review, after Sandoz re-submitted its product at the end of October.
- 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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