On March 1, Eli Lilly was the first to announce U.S. list price reductions of 70% for its most commonly prescribed insulins and an expansion of its Insulin Value Program that caps patient out-of-pocket costs at $35 or less per month. Lilly’s announcement noted that, effective May 1, it will…
As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year: USPTO Outlines New Initiatives Regarding Drug Pricing In July, we reported that Katherine Vidal, the Undersecretary of Commerce for Intellectual Property and Director of the USPTO, published a letter summarizing several…
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…
On Thursday, July 7, 2022, California Governor Gavin Newsom announced that the most recent state budget, signed last week, includes a $100 million allotment for California to “contract to make [its] own insulin at a cheaper price, close to at cost.” The budget designates $50 million for the development of…
This week, the FDA approved LYUMJEV (insulin lispro-aabc), a new insulin lispro product by Lilly. LYUMJEV is a formulation of insulin lispro, developed to speed the absorption of insulin into the blood stream and reduce A1C levels. Lilly’s insulin lispro product HUMALOG was originally approved in 1996. The corresponding Lilly…
On February 21, the FDA published a final rule in the Federal Register that implemented a requirement of the BPCIA, transitioning insulin, and some other products such as human growth hormone (somatropin), pancrelipase, chorionic gonadotropin, follitropinalfa, and menotropins, from regulation as small molecule drugs to biologics. With respect to insulin,…
Some noteworthy regulatory and litigation events related to insulin biosimilars have occurred recently. On May 13, 2019, FDA held a public hearing entitled “The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products” at FDA’s White Oak campus in Silver Spring, Maryland. …
On March 4, 2019, Eli Lilly announced that they will begin selling a lower-priced version of Humalog® (isulin lispro injection 100 units/mL) in the United States with a list price 50% lower than the current Humalog® list price. The lower-priced version will be called Insulin Lispro and will be provided in…