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What are the originator and generic drugs?
1. Safety and efficacy of pharmaceutical products
In order for a medicinal product to be authorized for the Cyprus market, it must obtain a Marketing Authorization from the Medicines Council, which is the competent authority. The marketing authorization for medicinal products is only issued when it is established that all quality standards are met throughout their development stages and when it is shown that they are effective and safe for the purpose for which they are intended.
2. Originator pharmaceutical products
A long-term research and spending of millions of euros is required before an original medicinal product is authorised. In order to be compensated for the very costly process of discovery and/or development of the new medicinal product, the company that "discovered" it, acquires a patent. Additionally this original medicinal product has a data protection period for a period of ten (10) years after its authorisation, during which no corresponding generic medicinal product can be placed on the market.
During the period when the original medicinal product has exclusivity on the market, it usually has a high price. Upon the end of its data protection period, another pharmaceutical industry can obtain a marketing authorization and legally market a generic (copy) medicinal product.
3. Generic pharmaceutical products
Generics are considered as “copies” of registered, original medicinal products which are already placed on the market. The dosage, method of administration, effectiveness, safety and quality of generics are comparable if not the same with that of the original products.
Generics consist of the same active ingredient or combination of active ingredients as the original medicinal products but their price is usually much lower compared with the price of the original medicinal product.
After the expiry of the data protection period of the original medicinal product, pharmaceutical companies operating and specializing in the manufacture of generics can market generics . As the companies that develop the generics are not burdened with research and development costs, generics cost far less than the original.
Generics are safe and effective and are constantly monitored just like the original medicinal products in terms of the occurrence of side effects.
The use of generics is one of the pillars of all modern health systems. The use of generics leads to significant savings, which are redistributed for the purchase of innovative and usually very expensive medicines.
4. Biological medicinal products
A separate category in the Catalogue of Medicinal Products are the biological and biosimilar medicinal products.
A biological medicinal product (or Biological) is the medicinal product, the active substance of which is biological. This substance is produced or extracted from a biological source, that is, a living organism.
5. Biosimilar medicinal products
A biosimilar medicinal product (or Biosimilar) is "similar" to a licensed biological medicinal product (or Biological). The active substance of a Biosimilar is "similar" to that of the Biological. Biosimilars and Biologicals are generally used at the same dose and for the treatment of the same disease. Biosimilars are not considered as generics of the original biological product.
The GHS Catalogue of Medicinal Products will include original, generic, biological and biosimilar medicinal products.