Dear Members and Friends,

We are contacting you to inform you about confirmed but concerning information we have received regarding the intention of the Pharmaceutical Services to proceed with the replacement of biological medicines with biosimilars. Following our participation in a scientific workshop on biosimilar and biological medicines organized by the European Federation of Crohn’s & Ulcerative Colitis Associations (EFCCA), and especially after our meeting with the Board of the Cyprus Gastroenterology Society, our Association has adopted the following fundamental positions:

1. The unilateral substitution of biological therapy with biosimilars in patients who are in remission is not scientifically justified and may put patients’ quality of life, and even their lives, at risk.
2. Automatic substitution of original biological medicines with biosimilars, or of one biosimilar with another biosimilar, should not be permitted.
3. Any consideration of using biosimilars in children is unacceptable, as sufficient time must first be allowed for their use in adults and for adequate research data to become available.
4. A registry of patients receiving biological therapies should be established so that data related to the safety and effectiveness of these new medicines can be systematically recorded.
5. The use of biosimilars in new patients should only occur with the informed consent of both the patient and their physician. Patients must be fully informed and aware of any potential benefits as well as any associated risks.
6. The introduction of biosimilars should be postponed until their successful implementation has been demonstrated in other countries. It is unreasonable for a country that does not even have dedicated gastroenterology clinics in its public hospitals to seek to pioneer the introduction of new treatment approaches.

For more detailed information, you may visit the CYCCA website, where the position statement of the Cyprus Gastroenterology Society and the findings of the workshop organized by the European Federation of Crohn’s & Ulcerative Colitis Associations (EFCCA) have been published.

You may also contact members of the Board at 70008084 for further information.