What is Bioequivalent Drug?

Equivalent medicines are the medicines which have the same features with innovator medicines thus it is scientifically proved that they provide the same treatment on the patient and they are put on the market after the expiration of protection of innovator medicine.
4 basic features of equivalent medicine are being effective, dependable, quality and economic.
An equivalent medicine has the same effectiveness, quality and safety with its innovator medicine..

What is Original/Reference Drug?

Innovator medicine is the first product put on the market under patent preservation produced by innovator firm. Equivalent medicines are produced after expiration of protection of these.medicines.

Is there any difference between bioequivalent and original drugs?

Every procedure from production to marketing is same with both equivalent and innovator medicines. The only difference is clinical practices on living things done on innovator medicines are applied.

At the present day, the repetition of clinical practices on living things for equivalent medicines, which were done for innovator medicines before by production firm, are not found ethical and healty for public health.
For equivalent medicines all researches and examinations are done asked by health authorities and it is proved that they provide the same treatment with bioequivalence practices.

The evidence that they provide the same treatment is bioequivalence practices.

	Regulatory Requirements	Reference	Equivalent
	General company info
	Product attributes (prescribing information, leaflets, packages)
	Expert report
	Drug composition
	Good Manufacturing Practices (GMP)
	Raw material control
	Finished product control
	Stability tests (API and finished product)
	Bioequivalent and reference product benchmark
	Pre-clinical studies
	Clinical studies
	Bioequivalence

What's bioequivalence?

Bioequivalence, shows that equivalent product and innovator product provide the same treatment in other words it is accepted as the guarantee of therapeutic equality.

Two medicines, which have the same effective substance that contain same or similar pharmaceutical forms and pass to blood at same rate and amount are bioequivalent with each other.

In our country' Regulations on Pharmaceutical Officinal Evaluation of Bioavaliability and Bioequivalence' was published in 1994.
Urgency to carry bioequivalence studies were put in to practice retrospectively considering the public health.
Approval process by the Ministry of the mentioned medicines continues. In this process none of the medicines have been pulled off the market because of non-equivalence.