2006 Competition Safety 
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.
PM360
SEPTEMBER 28, 2022
Chrys Kokino has been involved in the biosimilars market prior to the first biosimilar being approved in Europe in 2006. The entire premise was that because biosimilars were so new, and there was not a lot of information on the safety and efficacy of those products, customers should be a bit leery prior to jumping on the biosimilar bandwagon.
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Pharmaceutical Technology
MARCH 24, 2023
Biosimilars are an important tool to facilitate competition, lower the price of drugs, and create savings across the board. Currently, 40 biosimilars are FDA-approved and 25 have launched, whereas the EMA has approved 86 biosimilars since 2006. Further, there remains scepticism on the efficacy and safety of biosimilars.
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. The Impact of Biosimilar Competition in Europe, IQVIA, December 2021. EMA Guideline on Similar Biological Medicinal Products, 23 October 2014, CHMP/437/04 Rev 1.
European Pharmaceutical Review
FEBRUARY 7, 2023
In addition, the devices must not present an unacceptable risk to patient and user health and safety as established in Articles 94 and 95 of the MDR. However, a delicate balance will need to be struck between the need for affordable and accessible medicinal products and the desire to foster innovation and competitiveness in the EU.
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