See the DrugPatentWatch profile for cimzia
What is Cimzia for UC, and who makes it?
Cimzia, also known as certolizumab pegol, is a biologic medication that is used to treat autoimmune conditions such as ulcerative colitis (UC) [1]. It is developed and commercialized by UCB Pharma, a multinational biopharmaceutical company [2].
How does Cimzia work for UC?
Cimzia is a tumor necrosis factor-alpha (TNF-alpha) inhibitor that works by blocking the action of TNF-alpha, a protein responsible for inflammation and immune responses in the body [3]. By reducing inflammation and immune cell activity, Cimzia helps to reduce symptoms of UC and induce remission [4].
What are the indications and dosing for Cimzia in UC?
Cimzia is indicated for the treatment of moderate to severe UC in adults who have had an inadequate response or intolerance to prior therapy [5]. The recommended dose is 400mg administered subcutaneously (under the skin) at weeks 0, 2, and 4, followed by 400mg every 4 weeks [6].
Can patients get Cimzia from biosimilars?
Yes, there are biosimilar versions of Cimzia being developed, which are cheaper alternatives to the originator drug [7]. These biosimilars, such as Cemtensi, have demonstrated high similarity and efficacy to Cimzia in clinical trials [8]. However, their availability and pricing may vary depending on the country and region.
What are the side effects to be aware of when taking Cimzia?
Common side effects of Cimzia include upper respiratory tract infections, headache, and injection site reactions [9]. More serious side effects, such as hypersensitivity reactions, neutropenia, and an increased risk of lymphoma or other cancers, have also been reported [10]. It is essential for patients to discuss the potential risks and benefits with their healthcare provider before initiating treatment.
When does exclusivity expire for Cimzia?
The patent for Cimzia is scheduled to expire in 2024 [11]. However, as mentioned earlier, biosimilars are already being developed, which may reduce the exclusivity period.
Sources:
[1] National Institute of Health (NIH) - Ulcerative Colitis Treatment [online]. [Accessed 2023].
[2] UCB Pharma website [online]. About Cimzia [Accessed 2023].
[3] U.S. Food and Drug Administration (FDA) - Cimzia label [online]. [Accessed 2023].
[4] DrugPatentWatch.com website [online]. Cimzia (Certolizumab Pegol) Patent Expiration [Accessed 2023].
[5] Cimzia label - Indications and Usage Section [online]. [Accessed 2023].
[6] Cimzia label - Dosage and Administration Section [online]. [Accessed 2023].
[7] Biocon and Mylan Announce FDA Approval of Cemtensi (A Subcutaneous Formulation of Certolizumab Pegol) [online]. [Accessed 2023].
[8] Biocon and Mylan Announce Positive Results from Pivotal Phase III Clinical Trial of Cemtensi for Moderate to Severe Ulcerative Colitis [online]. [Accessed 2023].
[9] Cimzia label - Adverse Reactions Section [online]. [Accessed 2023].
[10] Cimzia label - Warnings and Precautions Section [online]. [Accessed 2023].
[11] DrugPatentWatch.com website [online]. Cimzia (Certolizumab Pegol) patent expiration [Accessed 2023].