Celltrion’s Remsima receives Turkish approval

July 17, 2014 11:15 AM

Celltrion announced yesterday that the Ministry of Health in Turkey (MoH) has granted marketing approval for Remsima (infliximab).

Celltrion has received approval from the MoH for all applied indications, which are for the treatment of rheumatoid arthritis, ankylosing spondilitis, Crohn’s disease, ulcerative colitis, psoriasis and psoriatic arthritis.

Last April 9th of 2013, Celltrion completed and submitted the application for Remsima approval to the Turkish Medicines and Medical Devices Agency and after one year and three months, Celltrion received official approval from the MoH. Remsima will be launched into the Turkish market beginning in the fourth quarter of this year, after administrative procedures are taken care of.

Turkey’s domestic pharmaceutical sector has a double-digit annual growth rate on average and is one of the fastest growing emerging markets. Turkey is the 6th largest pharmaceutical market in Europe and the 16th largest pharmaceutical market in the world. Estimated market size is approximately USD 150 million in terms of TNF-alfa inhibitor sales.

In addition, original drug versus generic drug ratio in 2010 was 48.6% to 51.4%. Fast market uptake of Remsima is expected as Turkey is one of the generic preferred markets. Celltrion will be marketing Remsima in Turkey through its partner company MN Pharmaceuticals (Mustafa Nevzat Pharmaceuticals), with a history of over ninety years as a leading biopharmaceutical company in Turkey. In 2012, MN was acquired by the global pharmaceutical company Amgen.

Source: Celltrion press release

 

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