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Original and reproduced drugs: what do the clinician need to know?

Author:
A.V. SHCHULKIN, A.A. FILIMONOVA
Federal State Budgetary Educational Institution of Higher Education “Ryazan State Medical University” of the Ministry of Health of the Russian Federation, Ryazan, Russia

Place of publication:
S.S. KORSAKOV JOURNAL OF NEUROLOGY AND PSYCHIATRY, 2021, Vol. 121, No. 10, Issue 2

Abstract:
This review article examines modern approaches to testing and registering generic drugs. It presents the history of generic drug research methodology and current Russian legislation. It describes the stages of confirming the equivalence of original and generic drugs: pharmaceutical equivalence, bioequivalence, and therapeutic equivalence. It also examines in detail the methods for assessing bioequivalence as a key test during generic drug registration. Using the example of the original Russian neuroprotector Mexidol (ethylmethylhydroxypyridine succinate) and its generic versions, it describes how legislative acts are implemented in practice. It concludes that not all generic drugs are interchangeable with the original drug.

Key words: original and generic drugs, generics, ethylmethylhydroxypyridine succinate, Mexidol.

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Actual

Results of an international multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of sequential therapy with ethylmethylhydroxypyridine succinate in patients in the acute and early recovery periods of ischemic stroke (IS)
Results of an international multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of sequential therapy with ethylmethylhydroxypyridine succinate in patients in the acute and early recovery periods of ischemic stroke (IS)
Cognitive disorders in the practice of a primary link: Focus for patients with arterial hypertension
Cognitive disorders in the practice of a primary link: Focus for patients with arterial hypertension
Resolution of the Council of Experts "The possibilities of neuroprotective therapy in patients with arterial hypertension and cognitive disorders"
Resolution of the Council of Experts "The possibilities of neuroprotective therapy in patients with arterial hypertension and cognitive disorders"
The results of an international multicenter randomized double-blind-controlled study of evaluating the effectiveness of the effectiveness and safety of consistent therapy of patients with chronic brain ischemia with Mexidol and Mexidol Forte 250 (study of Memo)
The results of an international multicenter randomized double-blind-controlled study of evaluating the effectiveness of the effectiveness and safety of consistent therapy of patients with chronic brain ischemia with Mexidol and Mexidol Forte 250 (study of Memo)
Reproduced drugs: Benefit ratio/risk
Reproduced drugs: Benefit ratio/risk
Treatment of patients with ischemic stroke in the vertebral-baslar system in the acute period: Experience in the use of the neuroprotective drug Mexidol
Treatment of patients with ischemic stroke in the vertebral-baslar system in the acute period: Experience in the use of the neuroprotective drug Mexidol
The use of Mexidol in patients with mild (moderate) cognitive disorders: the results of meta -analysis
The use of Mexidol in patients with mild (moderate) cognitive disorders: the results of meta -analysis
The effect of therapy with the drug Mexol on the regression of neurological deficiency and a functional outcome in patients with ischemic stroke: a systematic review and meta analysis
The effect of therapy with the drug Mexol on the regression of neurological deficiency and a functional outcome in patients with ischemic stroke: a systematic review and meta analysis
Arterial hypertension and cognitive disorders. The gaze of a neurologist
Arterial hypertension and cognitive disorders. The gaze of a neurologist
The effectiveness of Mexidol in patients of different age groups with chronic brain ischemia with cognitive disorders (the results of subanalysis of the international multicenter randomized double blind placebo-controlled study of memes)
The effectiveness of Mexidol in patients of different age groups with chronic brain ischemia with cognitive disorders (the results of subanalysis of the international multicenter randomized double blind placebo-controlled study of memes)
The effectiveness and safety of Mexidol in patients of different age groups in the acute and early recovery periods of the hemisphere ischemic stroke (the results of subanarized a randomized double blind multicenter placebo-controlled in parallel groups of the study of epic)
The effectiveness and safety of Mexidol in patients of different age groups in the acute and early recovery periods of the hemisphere ischemic stroke (the results of subanarized a randomized double blind multicenter placebo-controlled in parallel groups of the study of epic)
The results of a multicenter dual blind randomized placebo-controlled clinical study on the assessment of the effectiveness and safety of the drug Mexidol in the treatment of attention deficit syndrome in children (mega)
The results of a multicenter dual blind randomized placebo-controlled clinical study on the assessment of the effectiveness and safety of the drug Mexidol in the treatment of attention deficit syndrome in children (mega)

Actual

Results of an international multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of sequential therapy with ethylmethylhydroxypyridine succinate in patients in the acute and early recovery periods of ischemic stroke (IS)
Results of an international multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of sequential therapy with ethylmethylhydroxypyridine succinate in patients in the acute and early recovery periods of ischemic stroke (IS)
Cognitive disorders in the practice of a primary link: Focus for patients with arterial hypertension
Cognitive disorders in the practice of a primary link: Focus for patients with arterial hypertension
Resolution of the Council of Experts "The possibilities of neuroprotective therapy in patients with arterial hypertension and cognitive disorders"
Resolution of the Council of Experts "The possibilities of neuroprotective therapy in patients with arterial hypertension and cognitive disorders"
The results of an international multicenter randomized double-blind-controlled study of evaluating the effectiveness of the effectiveness and safety of consistent therapy of patients with chronic brain ischemia with Mexidol and Mexidol Forte 250 (study of Memo)
The results of an international multicenter randomized double-blind-controlled study of evaluating the effectiveness of the effectiveness and safety of consistent therapy of patients with chronic brain ischemia with Mexidol and Mexidol Forte 250 (study of Memo)
Reproduced drugs: Benefit ratio/risk
Reproduced drugs: Benefit ratio/risk
Treatment of patients with ischemic stroke in the vertebral-baslar system in the acute period: Experience in the use of the neuroprotective drug Mexidol
Treatment of patients with ischemic stroke in the vertebral-baslar system in the acute period: Experience in the use of the neuroprotective drug Mexidol
The use of Mexidol in patients with mild (moderate) cognitive disorders: the results of meta -analysis
The use of Mexidol in patients with mild (moderate) cognitive disorders: the results of meta -analysis
The effect of therapy with the drug Mexol on the regression of neurological deficiency and a functional outcome in patients with ischemic stroke: a systematic review and meta analysis
The effect of therapy with the drug Mexol on the regression of neurological deficiency and a functional outcome in patients with ischemic stroke: a systematic review and meta analysis
Arterial hypertension and cognitive disorders. The gaze of a neurologist
Arterial hypertension and cognitive disorders. The gaze of a neurologist
The effectiveness of Mexidol in patients of different age groups with chronic brain ischemia with cognitive disorders (the results of subanalysis of the international multicenter randomized double blind placebo-controlled study of memes)
The effectiveness of Mexidol in patients of different age groups with chronic brain ischemia with cognitive disorders (the results of subanalysis of the international multicenter randomized double blind placebo-controlled study of memes)
The effectiveness and safety of Mexidol in patients of different age groups in the acute and early recovery periods of the hemisphere ischemic stroke (the results of subanarized a randomized double blind multicenter placebo-controlled in parallel groups of the study of epic)
The effectiveness and safety of Mexidol in patients of different age groups in the acute and early recovery periods of the hemisphere ischemic stroke (the results of subanarized a randomized double blind multicenter placebo-controlled in parallel groups of the study of epic)
The results of a multicenter dual blind randomized placebo-controlled clinical study on the assessment of the effectiveness and safety of the drug Mexidol in the treatment of attention deficit syndrome in children (mega)
The results of a multicenter dual blind randomized placebo-controlled clinical study on the assessment of the effectiveness and safety of the drug Mexidol in the treatment of attention deficit syndrome in children (mega)

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