IEIS Panel Delivers Important Call to Action for the Pharmaceutical Industry

Executives of the Pharmaceutical Industry Employers' Association (İEİS) participated in symposiums organized within the scope of BIOEXPO and delivered important messages regarding the sector's needs and demands. One of the most notable sessions at BIOEXPO, held between 7-9 April 2021, was the "Current Approaches from R&D to Regulation in Biosimilar Medicines Symposium" on 8-9 April. The panel titled "Where Are We in Biosimilar Drug Development Projects? Barriers and Opportunities" held on 9 April was moderated by the Pharmaceutical Industry Employers' Association (İEİS). The panel, led by Murat Barlas, İEİS Board Member and President of the Turkey Biotechnological Medicines Platform, featured speakers from leading sector companies including Abdi İbrahim Ilaç Chief Executive Officer Dr. Süha Taşpolatoğlu, Atabay İlaç Research and Development and Innovation Director Doğan Taşkent, Dem İlaç Board Chairman Deniz Demir, Koçak İlaç External Relations and Business Development Director Cem Koçak, and Nobel İlaç General Manager Hakan Şahin. Representatives of exclusively domestic pharmaceutical companies, the panelists delivered detailed presentations on the intensive investments and activities in biosimilar drug development and manufacturing that have been ongoing for many years in our country. The issue that panelists particularly emphasized was the establishment of a regulatory system that takes our country's conditions into account and would lead our country to innovation in this field.  

Domestic Licensing Will Reduce Cost and Time in Manufacturing

The consensus view of industry leaders was that serious barriers still exist preventing biosimilar medicines, which the industry is actively developing and manufacturing, from reaching patients, and that this barrier is the regulatory system and licensing issue. According to information provided at the panel, these products are currently being licensed based on regulations formulated using the United States and EU as the basis. When license dossiers are reviewed, the processes often encounter additional requests that unnecessarily extend timelines and make production more expensive. The panelists expressed unanimous opinion that the practice of manufacturing based on foreign licenses hinders industry development and blocks the health system. Common examples mentioned in the discussions were the domestic licensing efforts of countries that have succeeded in this field, such as Argentina, South Korea, and India. Another important issue emphasized at the panel, which attracted considerable interest from participants and sector stakeholders, was the need for establishing an effective incentive system in this area. It was stated that, to date, the pharmaceutical industry has made significant investments with the physical investment incentives provided and continues to do so, but since the public incentive system is largely based on tax reductions and exemptions, it is insufficient from the industry's perspective. It was emphasized that return on investments is significantly delayed due to barriers to market entry of manufactured products. The demand for effective provision of financial project support in the field of biosimilar products, which require large-scale and continuous investment, was once again strongly emphasized by company executives.