Samsung Bioepis bolsters case for autoimmune biosimilars at EULAR

Engineers working at the Samsung Bioepis R&D Center
Engineers at the Samsung Bioepis R&D Center--Courtesy of Samsung

Incheon-based Samsung Bioepis presented long-term switching data derived from extension studies on 3 biosimilar autoimmune therapies to bolster the case on comparability to the originals as it seeks to capture market share.

The data shown this week at the annual European Congress of Rheumatology (EULAR) meeting in London was part of 7 poster presentations that included the firm's Benepali (etanercept/Enbrel), Flixabi (infliximab/Remicade) and candidate SB5 (adalimumab/Humira) that "demonstrated comparable efficacy and safety profiles after transitioning from the reference product to the biosimilar version," the company said in a release.

“Payers and healthcare providers must be given sufficient clinical evidence, so that they can make informed decisions when deciding whether to switch to a biosimilar treatment option,” Christopher Hansung Ko, president and CEO of Samsung Bioepis, said in a statement. “Our clinical studies have demonstrated that transitioning from a reference product to its biosimilar version yields comparable outcomes with regards to both the efficacy and safety of treatment.”

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Samsung Bioepis said Benepali and Enbrel "remained comparable" at week 100 for 254 rheumatoid arthritis patients in an extended Phase III study.

A second Phase III extended study showed Flixabi and Remicade comparable at week 78 in a trial that included 396 rheumatoid arthritis patients, some of whom switched to Flixabi from Remicade.

The third study showed that SB5 remained comparable for some patients that switched from Humira after 24 weeks.

Earlier this year, the European Commission approved Benepali and Flixabi, with the latter under review by the U.S. FDA. It is now sold in Korea as Renflexis.

Samsung Bioepis, a joint venture between majority partner South Korea's Samsung Biologics and Biogen ($BIIB), has ramped up regulatory efforts as it works with partners in the U.S. and Europe on sales and marketing efforts.

Other candidates in the company's pipeline are biosimilars of Sanofi's ($SNY) blockbuster insulin Lantus (insulin glargine), Roche's ($RHHBY) breast cancer drug Herceptin (trastuzumab) and its multicancer drug Avastin (bevacizumab)--with another 7 molecules in early stages.

- here's the release

Related Articles:
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Samsung Bioepis offers a glimpse at biosimilar manufacturing prowess
U.S. FDA accepts Samsung Bioepis infliximab biosim for review
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