EMA takes steps toward facilitating global clinical trials for biosimilars
Applicants for marketing authorisation for biosimilars in the European Union (“EU”), under certain conditions, will be able in the near future to use batches of reference biological medicinal products...
View ArticleEMA releases a draft revision to the Biosimilars Guideline for public...
The European Medicines Agency (“EMA”) initiated a public consultation on a proposed revision of its Guideline on “Similar Biological Medicinal Products” (the “Biosimilars Guideline”), available at the...
View ArticleEurope approves its first mAb biosimilar & FDA is handling 17 biosimilar INDs
Not surprising after the European Medicines Agency (EMA) positive opinion for two biosimilars to Remicade (infliximab) in June, the first of these was authorized in September. Authorization of Remsima...
View ArticleAIFA publishes “Second Concept Paper” on biosimilars
On June 15, 2016, AIFA (the Italian Medicines Agency) published a “Second Concept Paper” on the use of biosimilars within the National Health System (NHS). The document is intended to start a...
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