Life sciences · Türkiye
Biosimilars and biological medicines
Find scientific or regulatory contacts to discuss comparability and the evidence for a specified reference medicine. A similarity assessment considers both quality and clinical evidence.
Scientific background
State the reference medicine and the market in question when requesting a specialist introduction. Evidence accepted in one jurisdiction does not establish Turkish authorisation.
Biosimilarity is assessed against a specified biological reference medicine. A retrospective review of 38 development programmes that ultimately gained approval found immunogenicity differences in two programmes despite meeting efficacy endpoints. This selected sample of successful programmes cannot predict approval for a new product.
TİTCK revised its biosimilar development and licensing guidance in April 2026. A useful brief identifies the reference medicine, target market and outstanding comparability question. The competent authority assesses whether the evidence for an individual application is sufficient.
Request an introductionRequest an introduction
Looking for a doctor with expertise in a rare disease, or a specialist organisation for a pharma or biotech project? We find out who can take your enquiry. Once you approve sharing your contact details, that person or organisation contacts you directly.
For an initial introduction, we only need your email address and the area of interest. Please do not send health information or medical reports here.
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The request form will open once the privacy information for contact introductions has been published. Until then, this page does not collect or transmit any data.
General questions by email, please without health data: [email protected]