Mundipharma launches Remsima®▼ (infliximab), a new-generation value-based monoclonal antibody, in six European markets

• 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
• The reference product is the leading drug in its class, recording European sales of over $2 billion in 2013 alone¹
• 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

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, having secured distribution rights from Celltrion Healthcare Hungary Kft for Remsima in these markets.

Remsima is the first biosimilar monoclonal antibody authorised by the European Medicines Agency (EMA). Like the reference product, Remsima is authorised to treat rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis – conditions that affect over seven million people across Europe.^2,3,4,5,6

The reference product is the most successful in a class of medicines known as tumour necrosis factor alpha (TNF-a) inhibitors which also includes drugs such as Enbrel^® (etanercept) and Humira^® (adalimumab). In 2013 alone, it recorded sales of over $2 billion in Europe (including Russia and Turkey).¹ Remsima is expected to cost less than the reference product, representing an attractive option for cash strapped healthcare systems.

“Mundipharma is constantly looking for solutions that meet the needs of payers as well as improving the lives of patients and the healthcare professionals who care for them,” says Antony Mattessich, Managing Director, Mundipharma International Limited. “Our goal is to be the partner of choice for companies who are looking to commercialise their products. We are proud of our alliance with Celltrion and believe that Remsima is a perfect fit for today’s financially-constrained environment.”

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.⁷ Biosimilar monoclonal antibodies are expected to deliver the greatest savings, ranging from €1.8 to €20.4 billion in the same timeframe.⁷ 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.⁸

Following a rigorous EMA evaluation, Remsima has been found to be comparable to the reference products in terms of safety, efficacy and quality.^9,10,11 Two clinical trials were conducted to confirm EMA’s pre-clinical evaluation of Remsima. Both were randomised, double-blind, multi-centre 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.⁹ The PLANETRA study was a phase 3 study of 606 patients with rheumatoid arthritis.¹⁰ Together, these studies confirmed that Remsima is equivalent to the reference product in terms of efficacy and pharmacokinetics and comparable in terms of safety.

References:

1. Merck Annual Report 27 February 2014. http://www.merck.com/investors/financials/form-10-k-2013.pdf
2. Inflammatory Bowel Disease, Who gets ulcerative colitis and Crohn’s disease? efpia.eu/diseases/78/59/Inflammatory-Bowel-Disease Last accessed 15.01.15
3. NRAS, European Fit for Work Report. nras.org.uk/european-fit-for-work-report Last accessed 15.01.15
4. Ankylosing Spondylitis, Who does ankylosing spondylitis affect. efpia.eu/diseases/110/59/Ankylosing-Spondylitis. Last accessed 15.01.15
5. Augustin M and 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. rheumatology.org.uk/includes/documents/cm_docs/2012/b/bsr_guidelines_2012_
   treatment_of_psoriatic_arthritis_with_biologics.pdf. Last accessed 15.01.15
7. 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
8. Factors Supporting a Sustainable European Biosimilar Medicines Market. European Biosimilars Group September 2014 egagenerics.com/images/Website/GfK_Final_Report-_Factors_Supporting_a_Sustainable_European_Biosimilar_Medicines_Market.pdf Last accessed January 2015
9. 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)
10. 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)
11. Remsima Assessment Report 27 June 2013, http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002576/WC500151486.pdf