Merck/Samsung Bioepis’ Biosimilars Reach Primary Endpoints in Phase 3 Studies

Merck and Samsung Bioepis said that their biosimilars for Enbrel and Remicade both met primary endpoints in pivotal Phase 3 clinical trials, putting them on the path to filing regulatory submissions.

SB4, a biosimilar of Amgen’s Enbrel (etanercept), and SB2, a biosimilar of Janssen Biotech’s Remicade (infliximab), both showed equivalence to their reference biologicals at weeks 24 and 30 in patients with moderate to severe rheumatoid arthritis, despite methotrexate therapy. Enbrel and Remicade are used to treat autoimmune diseases such as psoriasis and rheumatoid arthritis.

The data on SB2 will be used to support a U.S. regulatory filing sometime in the next year, says Merck spokesman Robert Consalvo. Remicade’s patent expires in 2018.

The opportunity to commercialize SB4 in the U.S. won’t exist for years and isn’t part of the firms’ agreement. Enbrel’s patent was set to expire in 2012, but a new one was granted that extends exclusivity until 2028. “We feel the opportunity for licensing is available in other countries,” Consalvo says.

Under the collaboration, announced in 2013, Seoul, South Korea-based Samsung Bioepis will handle regulatory filings, clinical trials, manufacturing and clinical development, while Merck handles commercialization. — Charlotte Astor