Celltrion, one of South Korea’s leading biotechnology companies, has recently revealed a contour of its future strategy for the biosimilar business, targeting the global market.
Celltrion has reportedly decided to make clinical trials of biosimilars for Avastin and Humira this year, which will represent the “second wave” for the company’s biosimilar introductions, following the “first wave” products such as Ramsima, a biosimilar of J&J’s Ramicade, Herzuma, the one of Roche's blockbuster trastuzumab, and CT-P10, a candidate biosimilar of rituximab that is also widely known as Rituxan.
In addition to Avastin and Humira, Celltrion has been weighing the timing of clinical trials of biosimilars for Synagis (treatment for Respiratory Syndrome Prevention antibody), Erbitux (colorectal cancer treatment) and Enbrel (treatment for heumatoid arthritis).
The reason for Celltrion to choose Humira and Avastin as the next focus is that their combined market size reaches 21 trillion won (US$17.5 billion). In particular, the global sales of Humira in 2014 amounted to 14 trillion won (US$12.1billion), representing world's biggest-selling drug. Humira is used in a wide range of prescriptions including the one relating to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, and ulcerative colitis. The annual global sales of Avastin reached 7 trillion won (US$6.1 billion) in the same year. Avastin has been enjoying a stable and consistent demand although its global sales size is not as large as that of Humira.
Timing of Celltrion’s clinical trial of Humira is relatively late compared to its competitors at home and abroad. Multinational pharmaceutical companies, such as Pfizer and Merck, are known to enter the late stages in making clinical trials of Humira. US-based Amgen is also known to be proceeding with clinical trials for both Avastin and Humira, simultaneously. Samsung Bioepis has finished Phase III clinical trial for Humira.
The official at Celltrion explained, "Some analysts say that the patent expiration on Humira is imminent, but we judged that quite a few patents including formulation patents still have a considerable period remaining until expiration.”