Rumors Swirl as Eli Lilly Chairman John Lechleiter Visits Samsung Drug Companies

March 18, 2016
By Alex Keown, BioSpace.com Breaking News Staff

SEOUL, South Korea – A visit to the Korean headquarters of Samsung Bioepis and Samsung Biologics by John Lechleiter, chairman of Eli Lilly & Co. have fueled speculation on whether the companies are mulling over a potential partnership, the Korea Herald reported Thursday.

Questions arose as to whether or not Lechleiter was looking for a potential partner for Basaglar, Eli Lilly’s new biosimilar for Sanofi ’s diabetes blockbuster Lantus. The U.S. Food and Drug Administration cleared the way for Basaglar in December to control high blood sugar in adults and children with type 1 diabetes and adults with type 2 diabetes. Lilly’s Lantus biosimilar is expected to go on sale in the U.S. by December.

Biosimilars, which are made inside a living cell, are always uniquely different in composition, which differentiates them from generic drugs, which are exact replicas of other drugs. Biosimilar drugs have been widely available in Europe since 2006. Last year Sandoz, a subsidiary of Novartis AG, won approval for the first biosimilar drug in the United States, a version of Amgen ’s Neulasta, called pegfilgrastim, which is used to fight infection in cancer patients.

However, the Herald reported that spokespeople from both Samsung companies called Lechleiter’s visit a courtesy visit while he was traveling through Asia. Both companies told the Herald there were no talks about possible partnerships between the U.S. and Korean companies. The spokesperson for Samsung Bioepis did not rule out potential future partnerships with Eli Lilly. It is not likely though that such a partnership would revolve around Basaglar, as Samsung Bioepis has a working partnership with Merck to develop biosimilar, including one for Lantus that is in Phase III trials.

That partnership is already paying off. Merck and Samsung saw the approval of Renflexis, a biosimilar version of Remicade (infliximab), also known as SB2—for the treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, pediatric ulcerative colitis, psoriatic arthritis and plaque psoriasis. Renflexis is the second RA biosimilar for Samsung Bioepis. In September 2015, the company also saw Korea’s Ministry of Food and Drug Safety approve Brenzys, a biosimilar of Enbrel. In all, Merck and Samsung Bioepis are working on five biosimilar candidates in immunology, oncology and diabetes. The biosimilars include versions of AbbVie ’s Humira, Johnson & Johnson ’s Remicade, Roche ’s Herceptin and Brenzys and a version of Amgen’s Enbrel.

Biosimilars are being increasingly explored by drug companies to carve out earnings in new markets. Abbvie’s Humira is being targeted by several biosimilars. Not only is the Samsung/ Merck collaboration taking aim, but so is Amgen. In October, Amgen announced positive Phase III results of ABP 501, a biosimilar to Humira (adalimumab) in patients with rheumatoid arthritis. The FDA is expected to review the drug for approval by Sept. 25, 2016.

Likewise Janssen Biotech Inc. 's Remicade (infliximab) is also targeted by other companies for a biosimilar. While Merck and Samsung saw approval for their version, in February the U.S. Food and Drug Administration Arthritis Advisory Committee recommended approval of all eligible indications for Celltrion ’s CT-P13, a proposed biosimilar to Janssen Biotech Inc.'s Remicade (infliximab), by a vote of 21-3.