Mundipharma launches Remsima®, a new-generation value-based monoclonal antibody

•    The European Medicines Agency has determined that Remsima, a biosimilar, is comparable to the reference product Remicade® in terms of safety, efficacy and quality across all approved indications
•    Remsima is expected to cost less than the reference product; these savings could allow more patients with inflammatory autoimmune diseases to access monoclonal antibody therapy

•    The European Medicines Agency has determined that Remsima, a biosimilar, is comparable to the reference product Remicade® in terms of safety, efficacy and quality across all approved indications
•    Remsima is expected to cost less than the reference product; these savings could allow more patients with inflammatory autoimmune diseases to access monoclonal antibody therapy
•    Biosimilar monoclonal antibodies are expected to save European healthcare systems between €1.8 and €20.4 billion between 2007 and 2020 (1)

Mundipharma International Limited’s network of independent associated companies are launching Remsima (infliximab) this month in Germany, Italy, UK, Netherlands, Belgium and Luxembourg following expiry of the relevant patents and Supplementary Protection Certificates. Remsima is the first authorised biosimilar monoclonal antibody and is licenced by the European Medicines Agency (EMA) for the treatment of chronic, debilitating and often painful inflammatory autoimmune conditions that affect over seven million people across Europe. (2,3,4,5,6)

Like the reference product, Remsima is authorised for the treatment of patients with Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and psoriasis. It works by inhibiting tumour necrosis factor alpha (TNF-alpha), a naturally occurring protein that promotes inflammation.

Monoclonal antibodies are biologics – large, complex molecules isolated from natural sources, human, animal or microorganism. Biologics have led to significant improvements in the treatment of conditions such as inflammatory bowel disease (7) and rheumatoid arthritis (8) since their introduction in 1999, but growing usage has resulted in a high financial burden on European healthcare systems. (1)

Because biologics are derived from living organisms, no two batches of either the reference product or the biosimilar are identical.

Biosimilars are so-called because they are developed to be highly similar to already marketed biologics; the marketed biologic used as a comparator is known as the reference product. They are typically made at a lower cost than the reference product.

Biosimilars are projected to save European healthcare systems between €11.8 billion and €33.4 billion between 2007 and 2020, with the biggest savings predicted in France, Germany and the UK. (1) Biosimilar monoclonal antibodies are expected to deliver the greatest savings, ranging from €1.8 to €20.4 billion in the same timeframe. (1) These costs savings can be utilised to treat more patients with monoclonal antibody therapy, to treat patients earlier in the disease pathway or to reallocate resources. (9)

Following a rigorous EMA evaluation, Remsima has been found to be comparable to the reference product in terms of safety, efficacy and quality. (10,11,12) It is already available in a number of European countries including Norway.

“We’ve been using Remsima in Norway since January 2014. It’s our drug of choice when starting a new Crohn’s or colitis patient on a biologic and has already enabled the Norwegian healthcare system to make considerable savings,” says Jørgen Jahnsen, Professor of Medicine and Gastroenterology at the University of Oslo. “To date, I have used Remsima in 70 patients and have found it comparable to Remicade in terms of both efficacy and safety.”

Two clinical trials were conducted to confirm EMA’s pre-clinical evaluation of Remsima. Both were randomised, double-blind, multicentre studies of 54 weeks’ duration with an open label extension to 102 weeks. The PLANETAS study was a pharmacokinetic study of 250 patients with ankylosing spondylitis. (10) The PLANETRA study was a Phase III study of 606 patients with rheumatoid arthritis. (11) Together, these studies confirmed that Remsima is equivalent to the reference product in terms of efficacy and pharmacokinetics and comparable in terms of safety.

In the PLANETRA study, 73% of patients receiving Remsima achieved a greater than or equal to 20% improvement in rheumatoid arthritis symptoms after 30 weeks of treatment (measured using the ACR20 scoring system), compared with 70% treated with the reference product. Safety, immunogenicity and tolerability data were comparable. The most common side effects were viral infections, headache, upper respiratory-tract infection, sinusitis, nausea, abdominal pain, infusion-related reactions and pain. (11,13)

“Mundipharma is constantly looking to bring new treatments to market that improve patient access to quality healthcare at a price society can afford,” says Antony Mattessich, Managing Director, Mundipharma International Limited. “We believe that Remsima is a product that’s right for the times and look forward to bringing our expertise in pain management to the field of inflammatory autoimmune conditions.”

Mundipharma International Limited and its independent associated companies have secured distribution rights from Celltrion Healthcare Hungary Kft for Remsima in Germany, Italy, UK, Netherlands, Belgium and Luxembourg.

References:

1. Saving Money in the European Healthcare Systems with Biosimilars. Generics and Biosimilars Initiative Journal (GaBI Journal). 2012;1(3–4).120–6. http://gabi-journal.net/saving-money-in-the-european-healthcare-systems-with-biosimilars.html
2. Inflammatory Bowel Disease, Who gets ulcerative colitis and Crohn’s disease? www.efpia.eu/diseases/78/59/Inflammatory-Bowel-Disease. Last accessed 15 January 2015.
3. NRAS, European Fit for Work Report. www.nras.org.uk/european-fit-for-work-report Last accessed 15 January 2015.
4. Ankylosing Spondylitis, Who does ankylosing spondylitis affect.  www.efpia.eu/diseases/110/59/Ankylosing-Spondylitis. Last accessed 15 January 2015.
5. Augustin M, The European Expert Working Group for Healthcare in Psoriasis. A framework for improving the quality of care for people with psoriasis. JEADV 2012;26(Suppl 4):1–16.
6. Guidelines for the treatment of psoriatic arthritis, British Society for Rheumatology 2012 guidelines. www.rheumatology.org.uk/includes/documents/cm_docs/2012/b/bsr_guidelines_2012_treatment_of_psoriatic_arthritis_with_biologics.pdf. Last accessed 15 January 2015.
7. Haens GD. Risk and Benefits of biologic therapy for inflammatory bowel disease. Gut 2007;56(5):725–32. www.ncbi.nlm.nih.gov/pmc/articles/PMC1942157/
8. Keyser F. Choice of biologic therapy for patients with rheumatoid arthritis: The infection perspective. Curr Rheumatol Rev 2011;7(1): 77–87. www.ncbi.nlm.nih.gov/pmc/articles/PMC3182090/
9. Factors Supporting a Sustainable European Biosimilar Medicines Market. European Biosimilars Group September 2014 www.egagenerics.com/images/Website/GfK_Final_Report-_Factors_Supporting_a_Sustainable_European_Biosimilar_Medicines_Market.pdf Last accessed January 2015
10. Park W et al. Efficacy and Safety of CT-P13 (infliximab biosimilar) over Two Years in Patients with Ankylosing Spondylitis: Comparison Between Continuing with CT-P13 and Switching from Infliximab to CT-P13. Poster presented at ACR 2013, 25–30 October (abstract no. L15).
11. Yoo DH et al. Efficacy and Safety of CT-P13 (infliximab biosimilar) over Two Years in Patients with Rheumatoid Arthritis: Comparison between Continued CT-P13 and Switching from Infliximab to CT-P13. Oral presentation at ACR-ARHP meeting, October 2013 (abstract no. L1).
12. Remsima Assessment Report 27 June 2013 http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002576/WC500151486.pdf.
13. Yoo et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety ofCT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis 2013;72:1613–20.
14. Remsima Summary of Product Characteristics: EPAR http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002576/WC500150871.pdf.