Incheon-based Samsung Bioepis won a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for its Remicade biosimilar, paving the way for more competition in reimbursed markets in Europe.
The inflammatory disease therapy Flixabi, a biosimilar of infliximab, was recommended for approval after meeting EMA quality, efficacy and safety requirements for biosimilars, the South Korean company formed as part of a joint venture with Biogen ($BIIB) said in a press release.
SB2, the in-house name of the product, is one of 6 biosimilar candidates either approved in regulated markets such as Enbrel (etanercept) or in development on the regulatory pathway that include versions of Remicade, Lantus (insulin glargine), Humira (adalimumab), Herceptin (trastuzumab) and Avastin (bevacizumab)--with another 7 molecules at early stages.
"The CHMP's positive opinion on Flixabi brings us a step closer to broadening affordable, high-quality treatment options for autoimmune patients across Europe," Christopher Hansung Ko, president and CEO of Samsung Bioepis, said in a statement.
Samsung Bioepis CEO Christopher Ko
"We will continue to leverage our strengths in product development and quality assurance, so that we can increase patient access to a wider choice of life-enhancing medications."
For Remicade, formal marketing approval would put it head-to-head with a biosimilar version from Hospira, now owned by Pfizer ($PFE), and its South Korea-based partner Celltrion which sell under the brand names Inflectra and Remsima, respectively.
Sales of Remicade, partnered by Johnson & Johnson ($JNJ) and Merck ($MRK), have already been hit in Europe and elsewhere by a recent report suggesting real-world data on the use of Hospira/Celltrion's biosimilar found it safe and effective--and cheaper.
In February, the U.S. FDA's arthritis panel approved Celltrion's version in all indications including psoriatic arthritis, Crohn's disease, ulcerative colitis and psoriasis.
- here's the release