Abstract
Biologics are effective and have a good safety profile in the treatment of inflammatory bowel disease. Biosimilars have recently become available as treatment option. They are biological agents that are highly similar to the original biologic compound in their structure, biological activity, efficacy and safety. This position paper summarises current knowledge on biosimilars and presents its statements on regulatory issues and clinical situation in order to provide clinicians adequate information for them to reach informed and appropriate shared decision-making with their patients.
Highlights
Since the introduction of infliximab in 1999, biologics have revolutionised medical treatment in inflammatory bowel disease (IBD), demonstrating high efficacy and a good safety profile [1, 2]
Biosimilars have recently become available as treatment option
They are biological agents that are highly similar to the original biologic compound in their structure, biological activity, efficacy and safety
Summary
Since the introduction of infliximab in 1999, biologics have revolutionised medical treatment in inflammatory bowel disease (IBD), demonstrating high efficacy and a good safety profile [1, 2]. Physicians may choose from a variety of compounds to tailor their treatment to the individual patient. A biosimilar is a biological medicine highly similar to another, already approved biological medicine (called “reference product”) in terms of structure, biological activity and efficacy, safety and immunogenicity profile. CTP13 (manufactured by Celltrion, South Korea) was the first infliximab biosimilar to be approved by Swissmedic, the Swiss Regulatory Agency for Therapeutic Products [3]. Patents for many other biologics will expire in the near future and development of several biosimilars is underway
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