Bilim Pharmaceuticals is one of the leading generic companies in Turkey who can develop generic drugs. Now, lets focus on generic drug which is the basis for product development studies.

What is a generic drug? A generic drug is a drug which is produced and distributed without patent protection. A generic must contain the same active ingredients as the original formulation. Generic drugs are identical or bioequivalent to the brand name counterpart with respect to pharmacokinetic and pharmacodynamic properties. By extension, therefore, generics are identical in dose, strength, route of administration, safety, efficacy, and intended use. In Turkey as well as in developed countries (such as USA, EU, etc.) generic drugs are considered as effective alternative to original drugs and widely prescribed.

What is an original drug? Original drug is the first marketed drug for which its safety, efficacy and quality are proved scientifically.

What is the main difference between generic and original drug? Generic and original drugs are the same in terms of therapeutic effects.   Generic manufacturers do not spend the cost of drug discovery, and instead are able to reverse-engineer known drug compounds to allow them to manufacture bioequivalent versions. Generic manufacturers also do not bear the burden of proving the safety and efficacy of the drugs through clinical trials, since these trials have already been conducted by the brand name company. Also it has been accepted that performing these clinical trials again on animals and human being is not ethical and also is not acceptable in terms of public health.

Are the generic drugs as safe as original drugs? Yes. A generic drug contains the same active ingredients as the original drug and so it has the same pharmacological effect. Generic drugs are bioequivalent to the original drugs and provide the same benefits and adverse effects. Bilim Pharmaceuticals has state-of-art production facilities compliant to cGMP and other international regulatory standards. Bilim is also contract manufacturer of some innovator companies for local market and export.

Why does the generic drug cost less? Generic manufacturers do not bear the burden of proving the safety and efficacy of the drugs through clinical trials since these trials have already been conducted by the innovator company. Depending on country, generic drugs offer more economical option, such as 20% - 80% less price, for treatment.

What is the advantage of patients, governments and insurance companies from generic drugs? Generic drugs are bioequivalent to the original drugs and provide the same benefits and adverse effects. Generic drugs can save patients, governments and insurance companies substantial costs since they are cheaper than the original drugs. With these savings other expensive healthcare requirements for patients can be supported.

When generic drugs can be marketed? Generic drugs can be marketed when the patent protection and data exclusivity are expired.

Can a medicinal product have multiple patent protection? Yes. Medicinal products may have multiple patent protection. Patents are classified as; Basic molecule patent which protects molecule for intended treatment, Synthesis patent which protects synthesis route of molecule, Formulation patent which protects galenical formulation of finished dosage form, New indication patent which protects alternative therapeutic effects.

What is data exclusivity? Data exclusivity refers to the period during which the data of the original marketing authorization holder relating to (pre-) clinical testing is protected. Data exclusivity refers to the six or ten-year protection period granted to the original Marketing Authorization (MA) holder before generic applicants can file their applications for marketing authorization.

Who checks the quality, reliability and effectiveness of generic drugs? Like all other pharmaceuticals, the quality, reliability and effectiveness of generic drugs is audited and assured by the health authority which provides the license for the manufactured drugs. In order to receive a sales license for a generic drug, it must be "bioequivalent" with the original drug, i.e. it must essentially be similar to the original drug.

What is the importance of bioequivalence? Two pharmaceutical products are bioequivalent if they are pharmaceutically equivalent and their bioavailabilities (rate and extent of availability) after administration in the same molar dose are similar to such a degree that their effects, with respect to both efficacy and safety, can be expected to be essentially the same. Before dossier submission in CTD format to health authorities, bioequivalency must be proven between generic drug and original drug. Bioequivalency studies are performed under cGCP (Good Clinical Practices) guidelines at approved CROs (Clinical Research Organization), analysis of these studies are executed under cGLP (Good Laboratory Practices) guidelines issued by WHO (World Health Organization) and ICH.

Why is the presence of the generic drug industry important in Turkey? Because of the plans to bring general health insurance into effect and ensure that the medical system covers the entire population in the coming period, the use of generic drugs that are cheaper than the original drugs is advantageous in terms of saving public health expenses. On the other hand, when the production capacity of the domestic pharmaceutical industry is considered, the industry offers the necessary facilities like technology and compliance with GMP rules to sell its products in Turkey and to foreign countries.