The number of approvals given to South Korean biosimilar clinical trials has surpassed that of multinational pharmaceutical companies.
13 (in 10 items) out of the 25 biosimilar clinical trials (in 22 items) currently in progress are conducted by domestic companies. The number of approvals given clinical trials for domestic biosimilar increased from 2 in 2015 to 5 in 2016 and 7 in the January-March period this year. On the other hand, the figure for multinational drug companies decreased from 4 to 3 and 0 over the same period, according to the Ministry of Food and Drug Safety (MFDS) on April 12,
The 13 domestic biosimilar clinical trials are conducted by nine companies – three by two bio companies affiliated to Samsung Group, including two by Archigen Biotech Korea and one by Samsung Bioepis, two by CJ HealthCare, Chong Kun Dang and BIOCND each, one by LG Chem, Daewoong Pharmaceutical, Pangen and Schnell Biopharmaceuticals each.
Multinational pharmaceutical companies received approval for 12 biosimilar clinical experiments in total. Pfizer, which used to focus on synthetic drugs, received the largest number of approvals with five cases, followed by Boehringer Ingelheim with two and Milan, Sanofi–Aventis, Sandoz, Centus and Amgen with one each.
By the type of biomedicine, those related to rheumatoid arthritic drugs topped the list of approvals with eight cases. Humira, an autoimmune disease drug for RA manufactured by AbbVie, was the most aggressive with five cases.
LG Chem and BIOCND areconducting Phase 3 and 1 clinical trials for Humira’s biosimilars, respectively. BIOCND received approval for Phase 1 clinical trial for biosimilar of Novartis' Lucentis, a biomedicine for macular degeneration, for the third time in the world and the first time in Asia. As the company established a strategic alliance with China’s Genorbiopharma and QILU Pharmaceutical, it expects to quickly commercialize the drug in China as well.
The two Samsung affiliates are conducting Phase 3 clinical trials for Roche's Avastin and Mabthera biosimilars on patients with rheumatoid arthritic, non-Hodgkin lymphoma, a type of blood cancer, and non-small cell lung cancer.
Chong Kun Dang, CJ HealthCare and Pangen received approval for Phase 3 clinical tests of Nesp biosimilars, a long-acting erythropoiesis stimulating agent for treating anemia of chronic kidney disease patients which is marketed by Kyowa Hakko Kirin in Japan and Amgen in the U.S. It is a second-generation product that can be administered once every other week. Chong Kun Dang and CJ HealthCare are undertaking two clinical tests each for its intravenous injection for hospitals and clinics and hypodermic injection for patients.
Schnell Biopharmaceuticals received approval for Phase 1 clinical test of Janssen’s Remicade biosimilar, a rheumatoid arthritic treatment developed by its holding company Aprogen. Celltrion and Samsung Bioepis are only companies that are permitted to market the Remicade biosimilar in the world.