Biotech firms expanding abroadThe biotech arms of Korean conglomerates are accelerating their expansion overseas with lower-cost copies of globally renowned treatments.
Samsung Bioepis’ second biosimilar, Flixabi, a treatment for rheumatoid arthritis, is on the verge of receiving official approval in Europe, the company said on Sunday.
Flixabi has received a “positive recommendation” as a treatment for rheumatoid arthritis, ulcerative colitis, Crohn’s disease, ankylosing spondylitis and psoriatic arthritis from the Committee for Medicinal Products for Human Use under the European Medicines Agency (EMA), the company said in a press release.
The treatment will receive final approval after a legal review by the European Commission.
“CHMP’s positive opinion on Flixabi brings us a step closer to broadening affordable, high-quality treatment options for autoimmune patients across Europe,” said Christopher Hansung Ko, the president and CEO of Samsung Bioepis. “We will continue to leverage our strengths in product development and quality assurance so that we can increase patient access to a wider choice of life-enhancing medications.”
Flixabi is a biosimilar of Remicade by Janssen, which generates an average $8.8 billion in annual sales. If approved, it will be sold in 31 European countries for cheaper than Remicade.
Biosimilars, according to the U.S. Food and Drug Administration, are approved based on proof that they are highly similar to other FDA-approved products. The drugs have no clinically meaningful differences in terms of safety or effectiveness from the reference product while costing less.
CHMP’s recommendation of Flixabi was based on Phase 1 and Phase 3 clinical studies that tested the biosimilarity of Flixabi compared to Remicade on a total of 584 randomized patients with moderate to severe rheumatoid arthritis, the company said. In a 54-week Phase 3 clinical study, Flixabi showed “comparable safety and equivalent efficacy” to Remicade.
SK Chemicals is eyeing the American market for its patch-type Alzheimer’s disease treatment Exelon (SID710), a generic of Norvatis’ Exelon.
The company has filed an application with the U.S. Food and Drug Administration for sales approval, it said on Sunday.
Exelon is a circular patch that can be attached to any part of the body to ease the symptoms of Alzheimers. It was launched in the Korean market in 2014, and is currently being sold in 13 European countries including Germany, France, Britain and Spain. It has been a market leader in Europe for three consecutive years after being approved by the EMA in 2013. It was the first Exelon generic to enter Europe.
BY SONG SU-HYUN [firstname.lastname@example.org]
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