On July 28th, the U.S. Food and Drug Administration (FDA) announced the long-awaited approved of the first interchangeable biosimilar, Mylan’s SemgleeⓇ. Under the Biologic Price Competition and Innovation Act (BPCIA) of 2009, which governs U.S. biosimilar development, an interchangeable biosimilar may be substituted in place of its reference product (in this case, Sanofi’s insulin glargine LantusⓇ) at the pharmacy without the […]

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On June 24th, ASBM Executive Director Michael Reilly presented at the 15th Biosimilars Congregation. The event was organized to provide insight into the current state of play in the EU with respect to biosimilars and stimulate debate, in a multi-stakeholder setting, on the vital role of biosimilar medicines in the sustainability of healthcare systems. It also highlighted […]

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On June 29th, Minnesota Governor Tim Walz signed his state’s HHS Omnibus  budget for 2022-2023. The legislature had considered but ultimately rejected language aimed at boosting uptake of biosimilars – provisions which many patient groups believed might inadvertently increase out-of-pocket costs.   Since April, ASBM and other organizations including the Lupus and Allied Diseases Association (LADA, […]

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On April 23rd, President Biden signed into law S. 164, the “Advancing Education on Biosimilars Act of 2021,” which authorizes the Food and Drug Administration (FDA) to educate consumers and health care providers on biologic products, including biosimilars. In March, the US Senate unanimously passed the bill, which directs the FDA to improve education on biosimilars with […]

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On April 22nd, Oklahoma Governor Kevin Stitt signed SB 4, making Oklahoma the 50th and final state to enact a law permitting biosimilar substitution. SB 4, like similar legislation in other states, permits interchangeable biosimilars to be substituted at the pharmacy level once approved by the FDA. Patients and physicians must be informed of a […]

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