California Initiative Provides $100 Million to Produce Its Own Insulin Biosimilars

The rising cost of insulin is an issue with bipartisan interest. In 2019, the House held a hearing on rising insulin prices, and at the beginning of July, the House of Representatives passed a bill to limit the cost of insulin to $35 a month.

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 posted to Twitter.

The budget includes $100.7 million for the CalRX Biosimilar Insulin Initiative in 2022-2023, followed by $700,000 annually between 2023-2024 and 2025-2026. Of the funding, $50 million will go to the development of low-cost interchangeable biosimilar insulin products, $50 million to an insulin manufacturing facility based in California, and $700,000 annually to state operations.

California may not be alone. Other states, including Michigan, are also in the early stages of discussing the feasibility of developing insulin.

In January 2022, GoodRx reported that the average price per insulin unit rose 54% from $0.22 in 2014 to $0.34 in 2019; however, the price dropped 5% between January 2020 and October 2021. GoodRx attributed this decline to recent approvals of generics and biosimilars.

In July 2021, the FDA approved the first interchangeable biosimilar for insulin glargine, Semglee. According to GoodRx, retail prices for a unit of Semglee were about 60% lower than the retail prices of Lantus, the reference product. Semglee is still new to the market, and at the Asembia Specialty Pharmacy Summit in May 2022, Leslie Fish, RPh, PharmD, and Jeff Casberg, MS, RPh, both senior vice presidents of clinical pharmacy with IPD Analytics, reported that Semglee only had 4% of the market at the end of 2021.

Since then, a second insulin glargine biosimilar, Rezvoglar, has been approved. However, Rezvoglar does not have interchangeability status and it has not yet launched in the United States.

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 received a Complete Response Letter from the FDA for their submission for an insulin aspart biosimilar. Biocon has said it will address the issues in the letter.

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 Cardinal Health report found that diabetes prescribers felt they were very (63%) or somewhat (33%) familiar with biosimilars, but they were less likely (19%) than oncologists (67%), rheumatologists (42%), and ophthalmologists (32%) to prescribe a biosimilar for new patients. Only 30% of diabetes prescribers said they would be likely to prescribe biosimilars for existing patients having success on a reference product compared with 67% of oncologists and 42% of ophthalmologists. However, only 2% said they were “not likely to prescribe a biosimilar for any patient at this time” compared with 5% of oncologists, 7% of rheumatologists, and 25% of ophthalmologists.

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 said in a joint statement when they announced their bill at the end of June. “There is support on both sides of the aisle for this proposal and the American people cannot—and should not—have to wait a moment longer for relief.”