
California Initiative Provides $100 Million to Produce Its Own Insulin Biosimilars
The budget allocates half of the money for the development of low-cost interchangeable insulin biosimilars and the other half for building an insulin manufacturing facility in the state.
The rising cost of insulin is an issue with bipartisan interest. In 2019, the House
In the meantime, California is moving forward with plans to begin producing its own biosimilar insulin products. California’s governor, Gavin Newsom, recently signed the state’s budget for 2022 and 2023, which includes a $100 million allotment for developing low-cost insulin “to increase availability and affordability of insulin in the state.”
“Nothing epitomizes market failures more than the cost of insulin,” Newsom said in a video
California may not be alone. Other states,
In January 2022,
In July 2021, the FDA approved the
Since then, a second insulin glargine biosimilar, Rezvoglar,
According to Fish and Casberg, GeneSys and Civica Rx have biosimilars for insulin lispor, insulin aspart, and insulin glargine being developed. Civica Rx has reported that it hopes the biosimilars will be available by early 2024, and it is seeking interchangeability on all 3, according to Fish and Casberg.
At the beginning of the year, Viatris and Biocon
Sandoz and Gan & Lee are developing an insulin glargine biosimilar, and they may seek interchangeability if it is approved, according to Fish and Casberg.
One of the challenges when biosimilars launch is getting prescribers to switch from the reference product. A
In the meantime, Congress continues to work on capping insulin costs. The House bill that passed in early July caps the out-of-pocket cost of insulin at $35 a month for Medicare Part D beneficiaries, as well as certain group and individual plans. A similar bipartisan bill from Senators Jeanne Shaheen, D-New Hampshire, and Susan Collins, R-Maine, also has a $35-a-month cap.
The Senate bill has the support of the American Diabetes Association and JDRF but would require 10 Republicans to sign on in order to be passed.
“This legislation is the result of months of good-faith negotiations and input from lawmakers, advocates and experts. It is paramount that Congress acts swiftly, which is why we are calling on Senate leadership to bring our legislation to the floor as soon as possible,” Collins and Shaheen
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