LG Chem, Celltrion, and Samsung Bioepis said they have finished preparation to sell the biosimilars of Humira, an autoimmune disease treatment, in Japan, Europe, and Korea, respectively.
On Tuesday, LG Chem said in a public filing that it obtained approval from Japan’s Health Ministry for Adalimumab BS MA referencing AbbVie’s Humira (ingredient: adalimumab). The permit was granted for four types of syringe: syringe 20mg, 40mg, 80mg, and pen 40mg.
LG Chem’s Japanese partner company Mochida Pharmaceutical won the license for the biosimilar one year after applying for Adalimumab BS MA approval on March 24, 2020. Mochida has exclusive sales and marketing rights over the biosimilar in Japan.
LG Chem has been developing a Humira biosimilar with the code name LBAL. The company, then LG Life Sciences, agreed with Mochida in 2014 to develop a Humira biosimilar. In 2016, the two companies conducted phase-3 trials in Korea and Japan.
LG Chem’s biosimilar received nine indications -- rheumatoid arthritis, psoriasis vulgaris, psoriatic arthritis, pustular psoriasis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, intestinal Behcet’s disease, Crohn’s Disease, and ulcerative colitis.
Celltrion said it was targeting the European market with its biosimilar referencing Humira.
The company won the European Commission’s nod for CT-P17, a Humira biosimilar, on Feb. 11. Celltrion will sell CT-P17 under the brand name, Yuflyma in Europe.
The authorized indications of Yuflyma are identical to those of Humira. They include rheumatoid arthritis, inflammatory bowel disease, and psoriasis.
Celltrion emphasized that its product had a high concentration formulation. The company cut the drug dose in half and removed citrate, which can cause pain, securing differentiated marketability, it said.
While the two companies eyed on the overseas market, Samsung Bioepis said it would roll out its Humira biosimilar in the local market.
On March 15, Samsung Bioepis agreed with Yuhan Corp to sell the biosimilar Adalloce in the Korean market. In October 2018, Samsung Bioepis had already launched Humira biosimilar with the brand name Imraldi in Europe.
Samsung Bioepis obtained the local license for Adalloce in 2017. The company plans to launch the product in the first half of the year.
AbbVie’s Humira is the world’s best-selling drug. According to AbbVie’s 2020 annual report, Humira sold $19.83 billion worldwide.