On February 14, 2025, the U.S. Food and Drug Administration (“FDA”) approved Sanofi-Aventis U.S. LLC’s (“Sanofi”) MERILOG™ (insulin-aspart-szjj), a biosimilar to Novo Nordisk A/S’s (“Novo Nordisk”) NOVOLOG® (insulin aspart), for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus. MERILOG™ helps to lower mealtime spikes in…
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…
On July 5, Mylan announced another voluntary recall of a batch of Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens “due to the potential for the label to be missing on some pens.” The recalled product is not the branded SEMGLEE® pen, but rather the unbranded…
In October, Express Scripts announced that it would add Viatris’ SEMGLEE (insulin glargine-yfgn) injection as a preferred therapy on its formulary beginning in January 2022. Back in July, the FDA approved SEMGLEE as the first biosimilar insulin to improve glycemic control in adults and pediatric patients with type 1 diabetes and…
Last week, Biocon Ltd announced the approval of approximately a 150 million USD capital injection from Goldman Sachs. Dr. Christian Hamacher, CEO, Biocon Biologics, said, “This capital injection by Goldman Sachs will enable us to make prudent investments in R&D, high-quality manufacturing, as well as, establish a global commercial footprint.” …
Below are some highlights from third quarter 2020 earnings reports recently released by biologics and biosimilars companies: Biogen reported a decrease in year over year (YoY) revenue of 6% to $3.4 billion, but a 13% increase to $208 million in biosimilar revenue. It reported the following YoY revenue for each…
Mylan and Biocon’s NDA for Semglee (insulin glargine injection), was approved last week by the FDA, making it the third product approved by the FDA through the Mylan-Biocon Biologics collaboration. Semglee’s amino acid sequence is identical to that of Sanofi’s Lantus, and Biocon’s CEO and Managing Director, Dr. Christiane…