Резюме
Тарасенко О.О. Оригінальні та генеричні препарати в сучасній системі охорони здоров’я.
Згідно з даними експертів ВООЗ лікарські препарати займають 80-85% серед всіх видів медичної допомоги. Частота застосування генеричних препаратів досить висока в усіх країнах світу, що обумовлено можливістю зниження фактичних витрат на охорону здоров’я. У зв’язку з цим основною проблемою генерика є доказ його подоби оригінальному препарату. У статті розкриваються такі поняття як «інноваційний препарат», «бренд» і «генерик», наведені історичні етапи появи генериків і процедура їх. В роботі аналізуються трактування визначень терапевтичної еквівалентності генерика регуляторними органами різних країн (FDA, ВООЗ, EMEA). Окрему увагу приділено питанням фармацевтичної альтернативності лікарських засобів. У висновку наведено основні підходи до доказу взаємозамінності двох препаратів.
Ключові слова: інноваційний препарат, генерик, процедура впровадження генерика на ринок, підходи до доказу взаємозамінності двох препаратів.

Резюме
Тарасенко О.А. Оригинальные и генерические препараты в современной системе здравоохранения.
Согласно данным экспертов ВОЗ лекарственные препараты занимают 80-85% среди всех видов медицинской помощи. Частота применения генерических препаратов достаточно высока во всех странах мира, что обусловлено возможностью снижения фактических затрат на здравоохранение. В связи с этим основной проблемой генерика является доказательство его подобия оригинальному препарату. В статье раскрываются такие понятия как «инновационный препарат», «бренд» и «генерик», приведены исторические этапы появления генериков и процедура их внедрения на рынок. В работе анализируются трактовки определений терапевтической эквивалентности генерика регуляторными органами различных стран (FDA, ВОЗ, EMEA). Отдельное внимание уделено вопросам фармацевтической альтернативности лекарственных средств. В заключении приведены основные подходы к доказательству взаимозаменяемости двух препаратов.
Ключевые слова: инновационный препарат, генерик, процедура внедрения генерика на рынок, подходы к доказательству взаимозаменяемости двух препаратов.
Summary
Tarasenko O.A. Original and generic drugs in the modern-term health care system.
According to the WHO Expert drugs occupy 80-85% of all types of medical care. Frequency of application generates-cal drugs is quite high in all countries of the world, due to the possibility of reducing the actual costs of health care. In this connection, the main problem is the generic proof of its similarity to the original drug. The article describes the concepts such as “innovative drug”, “brand” and “generic”, given the historical stages of the emergence of generic drugs and the procedure of their introduction to the market. The paper examines the interpretation of the definition of therapeutic equivalence of generic regulatory authorities in different countries (FDA, WHO, EMEA). Special attention is paid to the issues of the pharmaceutical alternative medicines. In the conclusion the main approaches to the proof of the interchangeability of the two drugs.
Key words: innovative drug, generic, generic procedure introduction to the market, approaches to the proof of the interchangeability of the two drugs.

Рецензент: д. фарм. н., проф. Т.С. Сахарова

УДК 615.014.2/038/036.8

Национальный фармацевтический университет (Харьков)

National University of Pharmacy (Kharkov)

olga.tar.rogan@mail.ru

National health is one of the most important investment objects. In recent decades a consistent trend to growth of expenditures for healthcare is observed worldwide. According to data from WHO experts the drugs take 80-85% of all medical care types. The attempts of heavy regulation of prices for drugs in the context of market economy usually bring no success. Besides, in the result of controlled pricing total expenditures for medications may even increase, as far as the drugs cheapness sometimes stimulates their extra consumption. This is precisely why public health authorities of countries encourage entry into market of drugs that are equivalent to existing drugs, namely of generics. The share growth of these drug products in national pharmaceutical markets is observed almost in all countries and amounts up to 50% and more.

Generic substitution implies a substitution of a drug with another one containing the same active ingredient and is performed by pharmacist. There exist 4 stages of drug substitution: generic substitution is not allowed, generic substitution is allowed, generic substitution is encouraged, generic substitution is compulsory.

The history of pharmaceutical legislative framework creation accounts for many years on the way to patient protection from poor-quality and sometimes unsafe drugs. It is full of dramatic incidents ad crises of public confidence to safety of drugs and food. The term “generic” occurred in the seventies of the 20th century. It means that equivalent drugs are to be named with generic name, while original drug is to be sold under specific trade name. The definitions given nowadays to the generic drug by WHO and ЕМЕА are almost the same; however, the main difference is in value assessment and the necessity of carrying out the study on therapeutic equivalence in order to prove drugs equivalence in effectiveness and safety.

The requirements imposed on generic products are the same all over the world, that is: the content of the same active ingredient as in original drug; the same bioavailability; release in the same dosage form; comparability in quality, effectiveness and safety; absence of patent protection; compliance with the compendial requirements; production according to GMP (“Good Manufacturing Practice”); presence of the same indications and precautions for use; lower cost as compared to original drug.

The commitment to use generic drugs even in the conditions of low public solvency is justified only in the case when they are not obsolete and have proven equivalency to original drugs. Change of treatment method only on the basis of financial reasons may have serious negative influence on the patients’ health, especially for patients requiring constant treatment. It is impermissible to decide on the treatment method under influence of incorrect or misleading information. Thus, the main problem for generics is in proving of equivalence to original drugs. According to present-day ideas the “ideal” generic has to have effectiveness and safety drug therapy analogous to original drug, i.e. to be the same in terms of therapy. Study of generic drug is performed as to prove its therapeutic replaceability with the original one.

Ambiguity of results interpretation, absence of clear definitions of therapeutic equivalence specified by regulatory authorities of different countries (FDA, WHO, EMEA) leads to uncertainty both of medical doctors and patients in selection of drugs from the generic set. However, all the definitions of therapeutic equivalence provide for pharmaceutical equivalence/alternative and for carrying out of its study: bioequivalence study in humans (comparative pharmacokinetic study); comparative study of pharmacodynamics in humans; comparative clinical trials; dissolution test in vitro.

The choice of method of proving of therapeutic equivalence depends on physical and chemical properties of active substance, specific features of pharmacokinetics and pharmacodynamics, dosage form etc. Nowadays the common practice for pelleted generics is the acceptance of therapeutic equivalence on the basis of pharmacokinetic equivalence (bioequivalence). Thus, the generic selection is based on the fact that drugs bioequivalence is the indirect proof of their therapeutic effectiveness.

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