Multiple patents on original biologics delay when biosimilars get on the market in the US. University of Denver Sturm College of Law legal experts argue in a preprint that changes in how the original patents are written could reduce the number of duplicative patents and legal gamesmanship.
A Cleveland Clinic researcher anticipates that the FDA’s definition of strength of formulation could impair acceptance of Boehringer Ingelheim’s biosimilar to Humira (adalimumab), even though the FDA has approved the biosimilar as “interchangeable” to Humira.
Although spending on prescription drugs marched higher in 2021, the spending might have been significantly higher were it not for the savings from biosimilars, which appear to be gaining traction, according to a new report.
Marcus Snow, MD, , chair of the American College of Rheumatology’s Committee on Rheumatologic Care, discusses how additional clinical data and interchangeability designations could help build momentum for use of Humira (adalimumab) biosimilars when they start to arrive in 2023.