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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
[The war against generics and biosimilars in France: game over?]
1"Membre de l'Académie nationale de médecine, professeur émérite à la faculté de médecine de Marseille, Marseille, France".
Abstract:
"The war against generics and biosimilars in france: game over? French people seem get accustomed to generics use after a period of approximately two decades punctuated with reluctance, controversies, behavioral barriers, incentives, conventions and regulations. Fortunately the recent so-called Levothyrox crisis and the more confidential one about Valsartan have not had the deleterious impact that was feared. A more peaceful atmosphere if not resignation can now be noticed. Only three kinds of medically justified situations make now them out of hand: in case of narrow therapeutic margin; in the case of child under six if there is no generics adapted to him; in the case of patients showing a contraindication to excipient with known effect. The identification of these situations will ask judgement from the prescribers. The debates concerning biosimilars deployment did not find their root in biosimilars therapeutic indications which are extrapolations from the princeps indications even if biosimilars have been tested in one only of the princeps indications. They came from the French health authorities palinodes about their interchangeability. Far from assisting prescriptions, such palinodes could have generated prescribers' and patients' lack of confidence."
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