For several first-generation biologic medicines, including the biologic agent Remicade, the internationally established patent protection period is approaching expiration. This development allows new pharmaceutical manufacturers to develop and produce biosimilar medicines. As many of you may know, Remicade is highly effective and is administered to a significant number of patients living with Inflammatory Bowel Diseases (IBD), including Crohn’s disease and ulcerative colitis.

In Europe, the pharmaceutical company Alvogen has already obtained European approval for a medicine similar to Remicade under the brand name Inflectra. Another company, the South Korean-based Celltrion, has also announced plans to seek approval for its product marketed under the name CT-P13.

According to Petar Vazharov of Alvogen, Inflectra offers a more affordable yet equally effective treatment option for patients suffering from inflammatory diseases, while also providing significant cost-saving opportunities for European Union healthcare systems. (In the United States, Remicade’s exclusivity period was due to expire in 2018.) Cost reductions of up to 40% have been projected in some countries.

As the Cyprus Crohn’s and Colitis Association (CYCCA), we are closely monitoring developments in this area. We will soon be holding discussions with the Cyprus Gastroenterology Society and subsequently with the Ministry of Health. We have already established contact with the European Federation in order to obtain comprehensive information and to present a scientifically supported position during our meeting with the Minister.

Dear friends, what concerns us as patients whose health depends on these medicines is the fact that biosimilar products, unlike conventional generic medicines, are NOT identical copies of the original medicines. Rather, they are biologically similar products and only potentially equivalent. According to unconfirmed information available to us, the government pharmaceutical services may have already received Remicade substitute products, yet patients have not been informed about the policy governing their use.

The recommendations listed below include some of the key positions of the European Crohn’s and Colitis Organisation (ECCO) as outlined in its position statement, “The Use of Biosimilar Medicines in the Treatment of Inflammatory Bowel Disease (IBD)”:

1. Biosimilar products are NOT identical to their reference biologic products, as they are not manufactured through the exact same production process.
2. Biosimilar products are not generic medicines, and the automatic substitution of original biologic medicines with biosimilars is not recommended.
3. Both reference biologic products and biosimilars should be prescribed using their brand names to ensure traceability and facilitate patient safety monitoring.
4. The efficacy and safety of biosimilar products should be specifically demonstrated in patients with IBD, as experience with existing biologic therapies has shown that clinical effectiveness in IBD patients may differ from that observed in patients with other conditions, such as rheumatic diseases.
5. Clinical trials involving sufficiently large patient populations should be conducted in order to identify potential adverse effects and demonstrate equivalence with the reference biologic medicine.