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EMA-HMA Biosimilar Interchangeability Statement Offers ‘Unity And Clarity’ For Europe

Provides Foundation For Uptake Ahead Of Upcoming EU Pharmaceutical Legislation Reform

 
• By Dave Wallace

The recent statement by the EMA and HMA affirming the interchangeability of biologics and biosimilars has given a boost to Europe’s biosimilars industry ahead of key legislative reforms, heard delegates to Medicines for Europe’s 18th Biosimilar Medicines Conference in Brussels.

Isabell Remus Speaking At 18th Biosimilar Medicines Conference
Isabell Remus says the EMA-HMA statement brought “relief and joy” • Source: Medicines for Europe

The recent statement from the European Medicines Agency and Heads of Medicines Agencies on the scientific rationale supporting the interchangeability of biosimilar medicines in the EU “brings unity and clarity” to the European biosimilars arena and provides a foundation to support the wider uptake of biosimilars, according to Sandoz Europe’s head of biosimilars and specialty, Isabell Remus.

Speaking at European off-patent industry association Medicines for Europe’s 18th Biosimilar Medicines Conference in Brussels, Belgium, in early October, Remus – who is also chair of the association’s biosimilar medicines group – commented on the EMA-HMA

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