Project to Produce National Biosimilar Drug Molecule for Cancer Treatment Started

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A project to produce a national biosimilar drug molecule to be used in cancer treatment has started.

Turkey's two well-established institutions with half a century of history, NOBEL İLAÇ and TÜBİTAK MAM, are pioneering the establishment of a biotechnological drug production ecosystem by collaborating to develop and produce biotechnological molecules with entirely domestic resources.

Today, therapeutic monoclonal antibodies (MAbs) are recognized as revolutionary molecules in targeted therapy approaches, especially in the fields of oncology, immunology and organ transplantation. MAb-based biopharmaceuticals account for a significant portion of biotechnological drug expenditures in Turkey, all of which are imported from abroad. These drugs will increase their share in the coming years and will be used in the treatment of various deadly and common diseases, including cancer. However, biotechnological medicines are more expensive than conventional medicines as they have more complex and costly production technologies. The production of these drugs in Turkey, which are one of the biggest reasons for the foreign trade deficit in pharmaceuticals, will both facilitate patients' access to medicines and ensure more efficient use of public budgets allocated to health. In this respect, it is of critical importance for our country to bring to the market similar biopharmaceuticals whose patents have expired, just like chemical drugs.

Within the scope of the public R&D and domestic pharmaceutical industry partnership to be established with this project, a biosimilar of a biotechnological anticancer drug will be produced for the treatment of patients with metastatic colorectal and head and neck cancer using entirely domestic resources. For this purpose, a recombinant cell bank capable of producing the biosimilar drug will be established and the production, purification and analysis of the drug will be carried out in the pilot plant to be established and phase studies will be initiated. TÜBİTAK MAM GMBE will undertake the tasks within the scope of ensuring the continuity of the knowledge and gains to be obtained from the project results as the "Responsible Project Executing Organization (SPYK)".

As a result of this partnership, many new innovative and competitive biosimilar and original biopharmaceutical products will be developed in our country by establishing the infrastructure and technological know-how to produce world-class biopharmaceuticals, and will make great contributions to the national economy.

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