2001, Competition, Food and Safety

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2001

Competition

Food

Safety

Sweeping changes in leaked EU pharma law draft reignite profit vs access conflict

Pharmaceutical Technology

FEBRUARY 24, 2023

The revision process is reviving old conflicts in the pharma industry over fair and affordable access to medicines versus Europe’s status as a competitive home for pharma innovation. EU competitiveness Moll said the legislation revisions should instead be used to make Europe more attractive to pharma companies.

Pharma

Pharma Medicine Competition Food

Interchangeability of biosimilars in the EU – the industry impact

European Pharmaceutical Review

DECEMBER 19, 2022

3 Under this pathway, comparability studies are required to substantiate the similar nature, in terms of safety and efficacy, of the biosimilar and the reference product. This is reflected in the legal basis for biosimilars under Article 6 of Regulation 726/2004 and Article 10(4) of Directive 2001/83 (as amended by Directive 2004/27).

Medicine

Medicine Biopharma Safety Food

Pharma Rep Focus

Sweeping changes in leaked EU pharma law draft reignite profit vs access conflict

Interchangeability of biosimilars in the EU – the industry impact

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