On July 15, 2025, Biocon Biologics, a fully integrated global biosimilars company and a subsidiary of Biocon Ltd., announced that the FDA has approved KIRSTY (insulin aspart-xjhz injection), 100 units/mL, as the first and only interchangeable biosimilar to Novo Nordisk’s NOVOLOG (insulin aspart injection) in the United States. KIRSTY is…
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…
As we have previously reported, the Inflation Reduction Act (IRA) changed the government’s treatment of certain prescription drugs under the Medicare program by directing the Secretary of Health and Human Services (HHS) to establish the Drug Price Negotiation Program (“the Program”; see here for a full recap of the Program’s…
As we settle into 2024, we reflect on the significant legal developments of 2023 that hold potential impact on the biologics and biosimilars market. The following is a recap of some of the top five legal decisions and developments in the biosimilars and biologics space in 2023 that we covered…
According to PWC, “2023 was a reasonably strong year for the pharmaceutical and life sciences sector with both deal value and volume of M&A close to pre-pandemic levels.” Below is a recap of the top M&A deals in 2023 that focus on biologics and biosimilars and were covered on the…
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…
Insulin Biosimilars: Meitheal Pharmaceuticals, Inc. has announced an exclusive licensing agreement with Tonghua Dongbao Pharmaceuticals Co., Ltd. to commercialize Tonghua Dongbao’s three insulin biosimilars (insulin aspart, insulin lispro, and insulin glargine) in the U.S. market. Meitheal and Tonghua Dongbao will be jointly responsible for development and supply, with the expectation…
HHS has announced the ten drugs that will be included in the first year of the Inflation Reduction Act’s new Drug Price Negotiation Program. They are: Eliquis (apixaban, Bristol Myers Squibb) Jardiance (empagliflozin, Boehringer Ingelheim) Xarelto (rivaroxaban, Janssen Pharms) Januvia (sitagliptin phosphate, Merck Sharp Dohme) Farxiga (dapagliflozin, AstraZeneca AB) Entresto (sacubitril;…
As we previously reported, Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) announced its intent to acquire the global biosimilars business of its long-term partner Viatris, Inc. This week, Biocon confirmed completion of its acquisition in a part-cash/part-equity transaction. Under the terms of this USD $3.335 billion deal, Biocon paid…
On August 31, 2022, Biocon Biologics released a statement regarding three recent on-site FDA inspections of seven manufacturing facilities spanning two sites in Bengaluru, India and one site in Johor, Malaysia. The inspections took place between August 11 and August 30, 2022. The inspections were triggered by three preapproval inspections…