Policy Shift on Biosimilar Drugs Welcomed

Over the past decade, biotechnology methods have enabled the treatment of numerous diseases in the global pharmaceutical industry. Every country is working intensively to make biotechnological medicines accessible to patients. In this context, the rapid deployment of biosimilar medicines that enter the market after the intellectual property protection periods of reference biotechnological medicines expire plays a critical role. Last week, the European Association of Generic and Biosimilar Medicines 'Medicines for Europe' held the Biosimilar Medicines 2021 Conference. Many public and private sector representatives from various institutions and organizations attended the conference online. The European Union and the United Kingdom stated that they have made regulatory changes to enable biosimilar medicines to reach patients more rapidly.

Murat Barlas, Board Member of the Pharmaceutical Industry Employers' Union and President of the Turkey Biotechnological Medicine Platform, expressed satisfaction with the policy changes regarding biosimilar medicines in Europe, stating:

"In line with the scientific and technological developments in this field, many studies that were previously mandatory for biosimilar products are no longer necessary. In this context, practices that unnecessarily prolonged processes and increased costs are being discontinued. For years, we have been calling for regulations in our country that would enable biosimilar medicines developed and manufactured here to reach patients as soon as possible without compromising even the slightest on quality, efficacy and safety. Finally, we are beginning to see steps from Europe in the direction that we have long adopted and advocated. Without further delay, we expect our country to implement biosimilar medicine regulations tailored to our nation, guided by scientific principles, following the example of countries like Argentina and South Korea, which have become strong players in this field in a short time."