EMA accepts Enbrel biosimilar application for review

The European Medicines Agency has accepted a biosimilar Enbrel candidate from Samsung Bioepis of South Korea, according to a company press release.

In Europe and the U.S., Enbrel (etanercept, Amgen) is indicated for the treatment of rheumatoid arthritis and some kinds of juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. The acceptance of the marketing authorization application follows the results of a phase 3 clinical trial including patients with moderate-to-severe rheumatoid arthritis. The randomized, controlled, multicenter, European study of the drug, currently known as SB4, was designed to compare safety and efficacy of SB4 with etanercept. Study data will be available later in the year, according to the press release.

“This [marketing authorization application] validation represents a significant milestone for Samsung Bioepis in our work to develop and manufacture world-class biosimilars,” Christopher Hansung Ko, CEO of Samsung Bioepis, said in the release. “More significantly, it offers an opportunity to provide high-quality and effective therapies for broadening access to patients in Europe.”

In the U.S., a biosimilar drug, unlike a generic drug, must pass at least one clinical trial in which it is compared with the originating biologic drug already approved for use. In the E.U., a similar approval process was outlined in 2004, but clinical trials of a smaller scale are acceptable.

Currently, regulations for biosimilar drugs are under review by the FDA through a directive in the Affordable Care Act. Draft guidance documents have been issued by the FDA, but the regulations have not been finalized.

In the release, Samsung Bioepis reported it will also seek regulatory approval in other territories worldwide. The company is part of the Samsung group, which includes the manufacturer of consumer electronics.

References: www.samsungbioepis.com, www.fda.gov, www.rand.org.