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Celltrion’s Remsima (infliximab) receives positive opinion from EMA’s CHMP

2013.07.29

Celltrion’s RemsimaTM (infliximab) receives positive opinion from EMA’s CHMP for ankylosing spondylitis, rheumatoid arthritis, Crohn’s Disease, ulcerative colitis, psoriasis and psoriatic arthritis.
- Remsima (infliximab) is the world’s first biosimilar mAb to receive positive opinion from EMA’s CHMP

 
Celltrion announced on June 28, 2013 that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had given positive opinion for Celltrion-developed Remsima™ for sale in the European Union (EU). With this positive CHMP opinion, Celltrion is permitted to obtain marketing authorization approval (MAA) from 27 EU countries and 3 EEA (European Economic Area) countries (for a total of 30 countries) through simple administrative procedures rather than having to receive additional separate regulatory approval.
 
Remsima™ (infliximab) is the world’s first biosimilar mAb to receive positive opinion from an advanced and developed nations’ regulatory body. Celltrion elected for the path of centralized approval procedure instead of obtaining approval from each country’s regulatory authority, with the sales of Remsima™ in Europe as its goal. Celltrion’s infliximab product will also be receiving positive opinion from EMA under the trade name “Inflectra” to be marketed by Hospira.
 
Celltrion conducted global clinical trials involving 874 patients starting from March 2010 and lasting until November 2011 in 20 countries and 115 sites. For ankylosing spondylitis and rheumatoid arthritis, Remsima™ clinical trial phase 1 & phase 3 study results demonstrated clinical comparability to its original reference product in efficacy and safety profile. With these global clinical trial results, Celltrion’s RemsimaTM (infliximab) has received positive opinion from EMA’s CHMP for [ankylosing spondylitis, rheumatoid arthritis, Crohn’s Disease, ulcerative colitis, psoriasis and psoriatic arthritis.]
 
One of the primary investigators for Remsima™ (infliximab)’s global clinical trials, Professor Dae Hyun Yoo, (Hanyang University Hospital professor) declared, “Remsima™ demonstrated its comparability to its original reference product in efficacy and safety profile through non clinical & clinical trial studies. Therefore, the EMA has acknowledged the efficacy and safety of Remsima™ as an equivalent alternative for prescription to patients. There is much interest in Celltrion’s introduction of Remsima™ (infliximab) into the global market since Remsima™ (infliximab) will provide for an opportunity for more patients to receive equally effective treatment at a more affordable price. Remsima™ (infliximab) will promote patient access to advanced therapeutics.”
 
Celltrion further elaborated, “The European approval for Remsima™ is remarkably good news for patients who previously had limited access to advanced therapeutics, in particular, those hindered by the high cost of antibody biopharmaceuticals. We believe that the first biosimilar mAb approval by the EMA will spearhead the start of a new era of biosimilar mAbs in the pharmaceutical industry.”
  

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