Senator Dick Durbin, D-Illinois, said that the “termination cliff” on the transition date creates a “perverse incentive that could delay approval” for biosimilar insulins, and said that the new legislation would create a faster approval path for lower-cost products.
The Biologics Price Competition and Innovation Act (BPCIA) states that biologics that were originally approved through New Drug Applications (NDAs) under the Federal Food, Drug, and Cosmetic Act—such as insulins—will be deemed to be licensed as biologic products under the Public Health Service Act at the end of a 10-year transition period that closes on March 23, 2020.
As part of that transition, according to the FDA’s final guidance on the matter, any NDAs for transition products that are pending a decision on March 20, 2020 will receive Complete Responses. The FDA has indicated that these applications will have to be resubmitted via pathways for novel biologics or for biosimilars.
However, there has been concern that this approach by the FDA will lead to a “regulatory dead zone” in which insulin products will see delayed approval.
This month, a new item of legislation was introduced to address that potential problem. S.2103, or the Affordable Insulin Approvals Now Act, would amend the BPCIA to require that insulins with filing dates not later than December 31, 2019, would continue to be reviewed and approved under section 505 of the Food, Drug and Cosmetic Act, even if the review and approval process were to continue past the March transition date. These drugs would be deemed to be licensed as biologics effective on either the transition date or the date of approval, whichever comes later.
The bill was introduced by Senators Dick Durbin, D-Illinois, Kevin Cramer, R-North Dakota, and Tina Smith, D-Minnesota. In a statement, Durbin said that the “termination cliff” on the transition date creates a “perverse incentive that could delay approval” for biosimilar insulins, and said that the legislation would create a faster approval path for lower-cost products.
The legislation has received support from the Diabetes Patient Advocacy Coalition, the National Diabetes Volunteer Leadership Council, and Children with Diabetes.
This bill is part of a spate of action from law makers indented to address the problem of skyrocketing insulin costs. Also introduced this month was another bill targeting insulin: the Insulin Price Reduction Act. The bill would prohibit pharmacy benefit managers (PBMs) and insurers from receiving rebates for insulin if the drug maker has lowered its 2020 list prices to 2006 levels. To retain the rebate restriction in the next year, increases in the insulin’s list price must not exceed inflation. The rebate restrictions would apply to all private insurance plans and Medicare Part D plans.
In addition, the bill would require that PBMs and insurers waive the deductible for private insurance plans for any insulin that meets the list price reduction requirements each year.
Boosting Health Care Sustainability: The Role of Biosimilars in Latin America
November 21st 2024Biosimilars could improve access to biologic treatments and health care sustainability in Latin America, but their adoption is hindered by misconceptions, regulatory gaps, and weak pharmacovigilance, requiring targeted education and stronger regulations.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Can Global Policies to Boost Biosimilar Adoption Work in the US?
November 17th 2024On this special episode of Not So Different honoring Global Biosimilars Week, Craig Burton, executive director of the Biosimilars Council, explores how global policies—from incentives to health equity strategies—could boost biosimilar adoption in the US.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Challenges, Obstacles, and Future Directions for Anti-TNF Biosimilars in IBD
November 9th 2024A review article on tumor necrosis factor (TNF)-α inhibitors in inflammatory bowel disease (IBD) outlined current use of anti-TNF originators and biosimilars, their efficacy and safety, the benefits and challenges of biosimilars, and the future of biosimilars in IBD.
Skyrizi Overtakes Humira: “Product Hopping” Leaves Biosimilar Market in Limbo
November 7th 2024For the first time, Skyrizi (risankizumab-rzaa) has replaced Humira (reference adalimumab) as AbbVie’s sales driver, largely due to companies encouraging “product hopping” to avoid competition, creating concerns for the sustainability of the burgeoning adalimumab biosimilar market.