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Apotex Inc.

Latest From Apotex Inc.

Apotex's Neulasta, Neupogen Biosimilars Clear Legal Hurdles, But Approval Questions Remain

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.

BioPharmaceutical Policy

Samsung's Biosimilar Manufacturing Documents Lead Janssen To Drop Infringement Suit

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.

BioPharmaceutical Policy

Manufacturers Should Generate Own Elemental Impurity Data To Comply With ICH Q3D

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.

United States Europe

Four Biosimilar Pegfilgrastims Under EU Review After Sandoz Re-Submits Zioxtenzo

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.

Biosimilars Drug Review
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