Truxima to be launched in Europe following Remsima…Head to head competition against an original medicine
Kim Jee Seob | cloud50@ | 2017-02-23 14:33:25
Celltrion will go beyond the gateway of the developed European market, with ``Truxima`` following its biosimilar ``Remsima``, and it will face competition against original medicines in the KRW 8 trillion market.
Celltrion stated on February 22 that the firm has received sales approval from the European Medicines Agency (EMA) for antibody biosimilar Truxima (ingredient name: Rituximab) for the treatment of blood cancer and autoimmune diseases.
The European Medicines Agency has permitted Truxima sales authorization based on Celltrion request, including non-Hodgkin``s lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis.
Truxima is the world``s first anti-cancer anti-body biosimilar approved in the Europe and the original medicine is called Rituxan. Celltrion, with the permission of the EMA, is now able to sell Truxima in 31 countries in Europe, including 28 EU countries including the UK, Germany and Italy, and three European Economic Area (EEA), including Norway, Iceland and Liechtenstein. Celltrion will work with most of its existing partners, including Mundie Pharma of the USA, Biogaran of France, Kern of Spain etc. and will start Truxima sales from 2nd quarter of this year starting in UK.
According to the pharmaceutical market research institute- IMS data, the original Rituxan of Switzerland, which recorded global revenue of more than KRW 8 trillion last year, consumes about 45% of its global usage in Europe. Celltrion has already completed clinical trials for patients with indications for hematologic malignancies and rheumatoid arthritis and they have secured prescription rationale to increase product reliability from the medical community by publishing the clinical results to renowned institutes such as the European Rheumatology Society and the American Society of Hematology and Cancer.
Celltrion is expecting over KRW 3 trillion revenue within 2~3 years as its three antibodies such as Remsima, Truxima and Herzuma, are forming approximately KRW 25 trillion in original medicine of biosimilar worldwide market
A representative of Celltrion said that ‘We are expecting a global distribution partner for Truxima and Herzuma, which rams up in Europe and promotes in the United States following by remsima.’ He added that ‘We will do our best to expand market base with leading position not only in autoimmune disease but also anti-cancer drug fields as well’.
On the other hand, Celltrion is planning to apply for approval of the US Food and Drug Administration (FDA) in the first half of this year for both Truxima and Herzuma. Herzuma has already been applied for permission to the EMA in October, last year.
By Kim Jee Seob cloud50@
[ copyright ⓒ The Digitaltimes ]
Celltrion stated on February 22 that the firm has received sales approval from the European Medicines Agency (EMA) for antibody biosimilar Truxima (ingredient name: Rituximab) for the treatment of blood cancer and autoimmune diseases.
The European Medicines Agency has permitted Truxima sales authorization based on Celltrion request, including non-Hodgkin``s lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis.
Truxima is the world``s first anti-cancer anti-body biosimilar approved in the Europe and the original medicine is called Rituxan. Celltrion, with the permission of the EMA, is now able to sell Truxima in 31 countries in Europe, including 28 EU countries including the UK, Germany and Italy, and three European Economic Area (EEA), including Norway, Iceland and Liechtenstein. Celltrion will work with most of its existing partners, including Mundie Pharma of the USA, Biogaran of France, Kern of Spain etc. and will start Truxima sales from 2nd quarter of this year starting in UK.
According to the pharmaceutical market research institute- IMS data, the original Rituxan of Switzerland, which recorded global revenue of more than KRW 8 trillion last year, consumes about 45% of its global usage in Europe. Celltrion has already completed clinical trials for patients with indications for hematologic malignancies and rheumatoid arthritis and they have secured prescription rationale to increase product reliability from the medical community by publishing the clinical results to renowned institutes such as the European Rheumatology Society and the American Society of Hematology and Cancer.
Celltrion is expecting over KRW 3 trillion revenue within 2~3 years as its three antibodies such as Remsima, Truxima and Herzuma, are forming approximately KRW 25 trillion in original medicine of biosimilar worldwide market
A representative of Celltrion said that ‘We are expecting a global distribution partner for Truxima and Herzuma, which rams up in Europe and promotes in the United States following by remsima.’ He added that ‘We will do our best to expand market base with leading position not only in autoimmune disease but also anti-cancer drug fields as well’.
On the other hand, Celltrion is planning to apply for approval of the US Food and Drug Administration (FDA) in the first half of this year for both Truxima and Herzuma. Herzuma has already been applied for permission to the EMA in October, last year.
By Kim Jee Seob cloud50@