바이오스펙테이터

by Jongwon Jang

Infliximab SC patent protection until 2037 ... "Expect European sales license by the end of the year"

Celltrion announced on the 2nd of January that it had applied for a global patent for Remsima SC (CT-P13 SC), a subcutaneous injection of antibody bio-similar Remsima (component name infliximab) for the treatment of autoimmune diseases. At the end of last year, Celltrion had filed patent applications for Remsima SC in more than 90 countries around the world, including the United States as well as countries in Europe, Asia, Latin America, Eurasia, the Middle East, Africa and Oceania. Moreover, the patent will protect Remsima SC from other infliximab subcutaneous injections entering the market. Once registered, the patent will be in effect until 2037, granting the company an effective monopoly. "Humira, another subcutaneous injection, has blocked entry into the biosimilars market with a number of patents in the United States," said Celltrion. "If Remsima SC launches in the US, it will be possible to compete directly with Humira, which is aimed at treating inflammatory bowel disease (IBD), and is currently the only TNF-α inhibitor subcutaneous injection in the field. Celltrion expects Remsima SC to not only rival Remicade products such as Humira and Enbrel, but also penetrate the wider TNF-α inhibitor market aimed at autoimmune diseases, which is valued at over 36 trillion won.

Meanwhile, Celltrion said it is in the process of applying for a follow-up patent using clinical data from Remsima SC, in order to extend the company’s monopoly period.

“Since the product has not been used before, the dose, dosing method and dosage form of the drug can all be patented,” said a Celltrion official. “We expect that Remsima SC, which enhances patient’s convenience through its dosing method and increased performance, will become a biopharmaceutical that can surpass HUMIRA.” Meanwhile, Celltrion filed a license application for Remsima SC with the European Medicines Agency (EMA) on November 29 of last year, and is expecting permission to sell it in Europe this year.