Is there a difference between the brand-name drug and the generic aripiprazole drug?
The generic drug treats the same way as the original drug: scientific studies confirm this, both efficacy and safety. Also, all generic drugs corresponding to the same original drug have equivalent efficacy and safety in use. There is, therefore, no risk of switching from the original prescription to the generic in the event of mild illness or the possibility of long-term treatment. If in doubt, do not hesitate to talk to your doctor and pharmacist. If generic drugs are as effective and as safe as brand-name drugs, why do we need STUDIES to justify them? The studies of bioequivalence carried out before the marketing authorizations make it possible to guarantee that the generic medicinal product acts in the same way as the original medicinal product and, therefore, verify that the manufacturing processes and excipients do not call into question the efficacy and safety of the molecule. Indeed, to obtain the status of a "generic" drug, a drug must prove its pharmaceutical quality and its bioequivalence with the original medicine, that is to say, to prove that it has the same effectiveness and the same safety of use. Finally, designed from already existing molecules, generic drugs allow savings on research and development costs already amortized by original medications. In addition, they generally require less marketing and advertising costs. They can therefore be offered at a lower selling price while guaranteeing equivalent quality.
Are some generic cardiovascular drugs less effective than brand-name drugs?
The generic drug treats the same way as the brand-name drug. Scientific studies confirm this, both in terms of efficacy and safety. An analysis of the scientific literature confirms the equivalence of generic cardiovascular drugs with originator drugs in terms of clinical results. You will find more information on this study on the Effective and Safe Medicines page of the solidarites-sante.gouv.fr website. Do not hesitate to speak with your doctor to understand the reasons for his choice. Does the levothyroxine molecule have different effects in the generic form? The example of levothyroxine that you cite is one of the so-called "narrow therapeutic margin" drugs. These drugs are characterized by toxic (or ineffective) concentrations close to effective concentrations. Therefore, slight variations in dose or concentration may lead to a change in the benefit/risk ratio. Thus, the acceptability interval of the bioequivalence is tightened for this type of medication. As with all generic drugs, bioequivalence studies are carried out on finished products: they thus make it possible to guarantee that the excipients are chosen, and therefore the form of the drug, do not question the efficacy and safety of the molecule. The generic drug works at the same speed and in the same way in the body as the brand-name drug. In the case of drugs with a narrow therapeutic margin, any change during treatment must be made with caution, whether it is a change from one originator to another, from an originator to a generic specialty, or from a generic thing to another. The dosage adjustment is sensitive for both the generic drug and the original drug. It should be noted that no proof has been provided to date that there is a risk in substituting drugs with a narrow therapeutic margin.
What is most important for a drug: its bioequivalence or its effectiveness?
You are right; what matters above all is the effectiveness and safety of the drug. It turns out that the bioequivalence makes it possible to guarantee identical efficacy and safety of use between two drugs. To obtain marketing authorization, a generic drug must prove its bioequivalence with the original medicine, i.e., to demonstrate that it acts in the same way in the body and therefore to verify that the manufacturing processes and excipients do not call into question the efficacy and safety of the molecule. The generic drug does not have to prove the effectiveness of its molecule since the original laboratory has already demonstrated this through its program of clinical trials on numerous patients. Furthermore, scientific studies comparing the efficacy and safety of generic drugs and original drugs show no overall difference, including for drugs with a narrow therapeutic margin. I invite you to consult the studies in question on the Effective and Safe Medicines page of the pharm4all generic pharmacy website in the section bioequivalence.
Are generic drugs effective for diseases such as cancer, thyroid, and cardiovascular disease?
Generic medicine contains the same amount of the same active substance as the original medicine. Thus, it heals in the same way as the original medicine. Studies comparing the efficacy and safety of generic and brand-name drugs show no overall difference, including drugs with a narrow therapeutic window, such as thyroid treatments. Also, generic drugs are prescribed in hospitals to treat serious illnesses such as cancer or chronic diseases such as cardiovascular pathologies. It should be noted that drugs with a narrow therapeutic margin are drugs for which slight variations in dose or concentration can lead to a change in the benefit/risk ratio. This is why any change during treatment should be made with care, whether switching from one brand-name drug to another, from a brand-name drug to a generic drug, from one generic drug to another.
Can you swear that generics contain 100% of the active substance?
Yes. Indeed, a drug is considered generic on two conditions: it must contain strictly the same amount of the same active ingredient as the original drug; It must prove that it behaves in the same way as the original drug in the body. It must prove its "bioequivalence": to obtain its marketing authorization, the generic drug must demonstrate the amount of active ingredient available in the patient's blood and the speed at which it reaches circulation. Blood is similar to the original drug. This bioequivalence is the guarantee of therapeutic efficacy identical to that of the original drug. Therefore, a generic drug has the same active ingredient, in the same amount, as the original drug, and it acts in the same way in the body.
Why aren't generics the same as brand-name drugs? Does the difference of excipients call into question their effectiveness?
Suppose the generic drug may differ from the original drug on the composition in excipients. In that case, patents can prevent a generic drug company from using certain excipients, while he can already use the molecule fallen into the public domain. The excipients are inert substances without therapeutic activity. They are associated with the active principle of a drug (generic or original) to put it in shape and allow the arrival of the active substance in the part of the body where it must act. If the excipients of the generic drug may differ from those of the original medicine, this does not affect its effectiveness and safety. Indeed, to obtain the status of a "generic" drug, a drug must prove its bio-equivalence with the original drug: it must verify that it has the same amount of active ingredient and behaves in the same way. The way in the body, i.e., the active substance reaches the bloodstream at the same speed (bioavailability). Bioequivalence studies on finished products make it possible to guarantee that the excipients chosen do not call into question the efficacy and safety of the molecule.