by chuck_ltd | 6 Jan, 2017 | Biosimilars, CHCUK News & Articles
Europe’s biosimilar market continues to develop, with biosimilars in new classes approved and pending in applications before the European Medicines Agency (EMA). 22 biosimilars are approved in eight different product classes and 16 biosimilar applications, including...
by chuck_ltd | 17 Aug, 2016 | Biosimilars, CHCUK News & Articles, News
Guideline on Good Pharmacovigilance Practices (GVP). Product- or Population-Specific Considerations II: Biological Medicinal Products The European Medicines Agency (EMA) has adopted a new chapter to its guidelines on good pharmacovigilance practices (EU-GVP), entitled...
by chuck_ltd | 29 Apr, 2016 | Biosimilars, CHCUK News & Articles, News
Biosimilars, otherwise known as subsequent entry biologics or “SEBs” in Canada, are a rapidly emerging trend in healthcare. There is a common misconception that biosimilars are “generic” biologic medications. In reality, biosimilars and traditional generic...