South Korea's Samsung Bioepis has announced that the US Food and Drug Administration approved its copy of Johnson & Johnson's rheumatoid arthritis drug Remicade, the first drug developed by the Samsung Group unit approved in the US, reports Reuters Health.
The drug, called Renflexis, is a biosimilar – a copy of a biotech drug – and the second Remicade copy to be approved in the world's largest pharmaceutical market. Remicade is J&J's biggest selling drug with US sales of about $5bn a year.
The report says established in 2012 as a relative latecomer to the industry, Samsung Bioepis has found early success by beating rivals to market on biosimilars of some of the world's top-selling drugs by so far investing $1.3bn into biosimilar development.
It became the first company to launch a biosimilar version of Amgen's Enbrel, another rheumatoid arthritis drug, in Europe. It also submitted for approval its copy of Roche's blockbuster breast cancer drug Herceptin and its copy of AbbVie Inc's rheumatoid arthritis drug Humira, both in Europe.
The report says Renflexis will be marketed and distributed in the US by Merck & Co Inc. It received European approval in May 2016.
The FDA approved the drug a little more than a year after the first Remicade biosimilar copy – Pfizer's Inflectra, developed by South Korea's Celltrion – was approved. Inflectra was introduced in the US in late 2016.
Meanwhile, a European Medicines Agency (EMA) panel says that it recommends granting marketing approval to Sanofi and Regeneron's experimental drug to treat rheumatoid arthritis. Reuters Health reports that the Committee for Medicinal Products for Human Use gave a positive opinion on the drug, Kevzara, citing its ability to reduce the signs and symptoms of rheumatoid arthritis.
Sarilumab, the active substance of Kevzara, a treatment for adult patients with moderate to severe rheumatoid arthritis, works by blocking a protein called IL-6, which is associated with inflammation. The panel's opinion will now be reviewed by the EMA.
The report says in October 2016, US regulators declined to approve sarilumab because of manufacturing deficiencies at a Sanofi plant in France. Regeneron said in February that it was planning to resubmit a marketing application to the US Food and Drug Administration for sarilumab. The drug has already been approved by Canadian health regulators to treat rheumatoid arthritis.
More than 23m people worldwide suffer from rheumatoid arthritis. Current treatments include the widely-used methotrexate as well as non-steroidal anti-inflammatory drugs.
Other IL-6 inhibitors for rheumatoid arthritis include Roche Holding AG's approved Actemra and Johnson & Johnson's experimental sirukumab. The report says the FDA recently declined to approve a new rheumatoid arthritis drug, Olumiant, made by Eli Lilly and Co and partner Incyte Corporation.
[link url="http://www.reuters.com/article/us-samsung-bioepis-approval-usa-idUSKBN17N2LQ"]Reuters Health report[/link]
[link url="http://www.reuters.com/article/us-sanofi-fr-regeneron-pharms-ema-idUSKBN17N2BV"]Reuters Health report[/link]