Bioequivalent Drugs: Towards A Needed Holistic Paradigm Shift?
Journal Title: Drug Designing & Intellectual Properties International Journal - Year 2018, Vol 2, Issue 4
Abstract
The author of this short communication has been working in and teaching drug development for the last 20 years. He has been involved in more than 100 drug development projects, including drug delivery, medical device, biologics, innovators and generic drugs. He has also been involved in all the steps that are needed to file properly to different governmental agencies investigational new drug applications (IND), clinical trial applications (CTA), abbreviated and new drug applications/submissions (ANDA\S; NDA/S), 505b2, 510k and biologics legal applications (BLA). After several other interactions with all the other actors, such as Health Canada (HC), the Food and Drug Agency (FDA), the European Medicines Agency (EMA), pharmacovigilance companies and consultants, public relation companies, insurance companies and especially patients, the author has decided to gather all the comments in order to initiate a kind of a new debate on the innovators and generic drugs. However, the goal of this current expert opinion is not to generate conflicts, or to compare generic versus innovator drugs in the sense that one is better than the other. The author has already been involved in several bioequivalence studies, comparing two innovator products where the results showed lack of bioequivalence….or in bioequivalence studies evaluated with clinical endpoint where generic drug products were more potent than the innovators…The goal of this paper should be more based on the following question: are the current methods used to assess bioequivalence are suitable and reliable enough to “stamp” that generic drugs are bioequivalent, are as stable, reliable form a quality, a safety and efficacy standpoints.Based on the literature generic drugs can be defined as copies of innovator drugs and should contain the same dose strength, the same indication, pharmacodynamical effects, adverse events, safety profile and route of administration than the brand drug. Basically, generic drugs should behave the same than the innovator drugs. To achieve this equivalent profile, drug substance should be formulated and mimic as much as possible the formulation of the brand. It means that drug products ideally should show the same composition from both a chemical but also from a physical point of view. If these last comments are achieved then the biopharmaceutical phase, therefore the phase where the active pharmaceutical ingredient (API) should become available to the body, this phase should be equivalent between the generic and the brand. To help formulators developing bioequivalent formulation, several tools and development methods have been developed over the last decades.
Authors and Affiliations
François-Xavier Lacasse
Keywords
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- EP ID EP588790
- DOI 10.32474/DDIPIJ.2018.02.000144
- Views 156
- Downloads 0
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