BIOLOGICAL AND BIOSIMILAR DRUGS
The draft Guideline for the Licensing of Biologicals and Biosimilar Medicines which was opened for comments in May 2017 was not unfortunately published in 2020 either.
Turkey's 2023 vision targets to focus on research and development in healthcare, to develop a value creating ecosystem with the contributions of domestic and foreign invesment. In parallel with the developments in the world, the prioritization of investment in biotechnological medicines appears as a strategic necessity. To achieve this objective, robust and sustainable, science-based regulatory frameworks for innovative products, including biotechnologicals, should be developed and implemented. This approach is particularly important for the safe delivery of medicines to patients.
Turkish pharma is not large enough to shoulder the cost of domestic biosimilar medicines manufacturing. Production of local biosimilars should aim to be marketed in high value foreign markets. Countries that have a manufacturing advantage in this field, such as India, China and Cuba are low value markets which afford to sell their products at a loss. Thus, regulatory system to be adapted by the Turkish authorities would also determine the marketing horizon.
If the regulatory framework at the time of of the licensing of biosimilar product is compatible with the regulatory climate of the targeted markets, the product would have a chance to be valued in target markets. As we are currently awaiting a legislation on biosimilars in Turkey, there is no biosimilar product that can officially be submitted to global markets.
In case the legislation is developed, as demanded by some industry representatives , as “country-tailored guideline criteria”, the risk of restricting the market to Turkey only is very high. It is impossible to achieve the expected economic gains by targeting the local market only.
It is certain, however, that biosimilar medicines, which would be produced according to a national legislation in compliance with international criteria, would foster the trust of of foreign licensing health authorities, would bring the export advantage due to compliance with international criteria and will make an important contribution to our national economy.
WHO has drawn the attention to the increase of non- comparable biologics (NCBs) manufactured in countries that do not have science-based guidelines prepared according to WHO 2009 criteria (Argentina, Brazil, Thailand, Colombia, etc.). There is a risk that such products proliferate and enter our market as well.
In this context, 2020 has been a year that we continued to emphasise the importance of the speedy publication of the draft guideline prepared in accordance with the EMA and FDA requirements, to make our country a competitive player in the biosimilars global market.
As AIFD, as companies that develop both the reference products and biosimilars, we highly desire that the draft guideline be published and put into effect as soon as possible as it will guide us in our applications. Due to the high investment costs and long investment return period in this field, Turkey has a limited market size.
Therefore, biological products to be developed in Turkey should have the quality level to target world markets.
The most important project of 2020 was a scientific publication on Biological and Biosimilars, prepared under AIFD coordination. The authors, all academicians who are experts in their fields, are gathered at regular intervals and the content was put together. The book, designed both in print and in digital formats, was published in the third quarter of 2020. The book covers a wide range of scientific subjects, a compilation of chapters from R&D processes of biotechnological drugs to their clinical studies, from immunogenicity to pharmacovigilance.
AIFD undertook all the publication and distribution activities of this scientific book, which was written to be a reference resource for everyone interested in biological and biosimilar products, especially all healthcare professionals.
The digital version of the book and its content can be accessed on the website of “biyoteknolojikilaclar.net”. The current printed version of the book can also be requested through this site.
