Meitheal Announces Exclusive Commercial Licensing Agreement for Insulin Biosimilars in the US

Meitheal Pharmaceuticals, Inc. (“Meitheal”) has entered into an exclusive licensing deal with Tonghua Dongbao Pharmaceutical Co., Ltd. (“THDB”) to market three insulin biosimilars (insulin aspart, insulin lispro, and insulin glargine) in the United States.  The agreement grants Meitheal and its parent company, Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (“NKF”), exclusive rights to commercialize the three biosimilar insulin products upon approval by the FDA, estimated to be on or around 2026.  THDB and NKF will jointly handle product development and supply.

To date, there are two FDA-approved biosimilars to Sanofi’s LANTUS (insulin glargine): Eli Lilly’s REZVOGLAR (insulin glargine-aglr) and Mylan’s SEMGLEE (insulin glargine-yfgn).  The FDA has not yet approved any biosimilar insulin aspart or insulin lispro products.