- 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 alone(1)
- 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.
Expiration of patents and Supplementary Protection Certificates protecting the reference product
- The Netherlands - 12 February 2015
- Germany, Italy and Luxembourg - 13 February 2015
- United Kingdom - 24 February 2015
- Belgium – 25 February 2015
The Mundipharma network of independent associated companies consists of privately owned companies and joint ventures covering the world's pharmaceutical markets. These companies are committed to bringing to patients the benefits of pioneering treatment options in the core therapy areas of oncology, pain, respiratory and inflammatory conditions. They are also committed to independent thinking and ground breaking solutions. Through innovation, design and acquisition, the Mundipharma network of independent associated companies delivers cutting-edge treatments to meet the most pressing needs of healthcare professionals and patients. For further information please visit: www.mundipharma.com.
Remsimais a medicinal product containing a monoclonal antibody called infliximab. Following an extensive comparability exercise between Remsimaand the reference product it was demonstrated via quality, nonclinical and clinical data that all major physicochemical characteristics and biological activities of Remsima were comparable to those of the reference product. The therapeutic indications as well as the dosing regimen for Remsima are the same as those of the reference product; the pharmaceutical form (powder for concentrate for solution for infusion) and strength (100 mg infliximab per vial) are also the same.12 Remsima is therefore indicated in the same settings as reference infliximab: rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, adult and paediatric Crohn’s disease and adult and paediatric ulcerative colitis.12
Biosimilar is a term used to describe officially approved subsequent versions of biopharmaceutical products that are made available by a different company following patent and exclusivity expiry on the original product. Biosimilars are classed as biologic medical products, which means they contain an active drug substance that is comprised of, or derived from, a living organism. Biosimilars are strictly regulated and need to demonstrate comparability to the previously approved product via a thorough development programme including quality, nonclinical and clinical data. As part of the comparability exercise for Remsima it was shown that all major physicochemical characteristics and biological activities were comparable to those of Remicade, which is the initial product in this instance.