On November 25, 2021, Japan-based Mochida Pharmaceutical Co. announced that its adalimumab biosimilar, Adalimumab BS MA, had been launched in Japan following the listing of the drug on the National Health Insurance. According to the press release, Adalimumab BS MA is the first adalimumab biosimilar to Humira currently distributed in…
On March 29, Samsung Bioepis announced the launch of its adalimumab biosimilar HadlimaTM, referencing AbbVie’s HumiraTM, in Australia in partnership with Merck & Co. HadlimaTM is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult and paediatric Crohn’s disease, ulcerative colitis, hidradenitis suppurativa and…
Below are some highlights of recent biosimilar development news from this week: On September 20, Mochida announced that it had obtained marketing approval in Japan for RGB-10, a biosimilar of FORTEO (teraparitide) that Mochida developed in Japan based on a comprehensive license and collaboration agreement with Gedeon Richter Plc. Mochida…
Several biopharmaceutical developers recently announced significant regulatory submission activity in connection with biosimilar products in their pipelines. In addition to yesterday’s news about the U.S. FDA’s approval of Mylan and Biocon’s Fulphila™ (pegfilgrastim-jmdb) biosimilar product, below are some highlights: On June 1, the Committee for Medicinal Products for Human Use…
Last Friday, Japanese company Mochida Pharmaceutical with Korean company LG Chem announced that it has received sales approval from the Japanese Ministry of Health, Labour and Welfare on its etanercept biosimilar (marketed by Amgen as ENBREL®) for the treatment of rheumatoid arthritis and juvenile idiopathic arthritis. LG Chem has a…
LG Life Sciences recently announced the start of phase III clinical trials for its Humira® (adalimumab) biosimilar in South Korea. The clinical trials will test the effectiveness of the biosimilar on rheumatoid arthritis patients who have shown negative responses to the chemotherapy drug methotrexate. The trials will also compare the efficacy and safety…