New product-specific bioequivalence guidance
Journal Title: Generics and Biosimilars Initiative Journal - Year 2014, Vol 3, Issue 1
Abstract
For harmonization of the authorization requirements for specific generic applications within the EU, consistent criteria were drafted for 16 active substances, which are out now for public consultation.
Authors and Affiliations
Christoph Baumgärtel
Keywords
Related Articles
- EP ID EP354200
- DOI 10.5639/gabij.2014.0301.009
- Views 122
- Downloads 0
Access to liposomal generic formulations: beyond AmBisome and Doxil/Caelyx
The lack of clear regulatory guidance remains a key bottleneck for securing a second quality-assured source of liposomal amphotericin B (LAmB), the WHO-recommended drug for visceral leishmaniasis. The approval of the fir...
Statin generics: no differences in efficacy after switching
A study presented at the 2010 Congress of the European Society of Cardiology, had created a considerable stir. Its abstract allegedly showed that the originator drug Lipitor was more beneficial than any of its generic st...
Legislative efforts to limit prescription information sharing between patients and healthcare providers represent a serious threat to the health and safety of the American nation
Legislation in support of pharmacist notification to patients and providers of substitution of an interchangeable biologic for the originator biologic was recently vetoed in California. Automatic substitution of approved...
Top developments in biosimilars during 2013
The past year has been a busy one for the biosimilars industry. Perhaps one of the most important milestones during 2013 was the European approval of the first monoclonal antibody biosimilar [Remsima/Inflectra (inflixima...
Tyrosine kinase inhibitors becoming generic drugs – risks and chances from a regulatory perspective
Aim: To provide a systematic overview on: i) safety profiles; ii) pharmacokinetic parameters; and iii) regulatory framework of anti-cancer tyrosine kinase inhibitors (TKI). Methodology: Recherché of pharmakokinetic (PK)-...