Since the biosimilars pathway (BPCIA) was established in 2010, 30* biosimilars have been approved. However, due to significant barriers to market entry, just 20 biosimilars are available to patients —and even fewer have significant market uptake. Because FDA-approved biosimilars provide market-based competition for costly biologics, this slow market adoption is leaving significant savings on the table for patients and taxpayers. In fact, AAM’s Biosimilars Council found the health care system has lost nearly $2.2 billion in savings due to slow biosimilar adoption. The three legislative proposals below would help strengthen biosimilar adoption and ensure savings for patients and Medicare.
Increase Patient Access to Lower-Cost Biosimilar Medicines
Encourage Physician Use of Lower-Cost Biosimilars – Cosponsor the BIOSIM Act (H.R. 2815)
- Currently, providers in Medicare Part B are reimbursed for administering biosimilars at ASP+6% of the brand-name biologic.
- The BIOSIM Act, introduced by Reps. Kurt Schrader (D-OR) and Adam Kinzinger (R-IL) would increase reimbursement for biosimilars by 2% to ASP+8% and would apply only when the biosimilar’s ASP is lower than the brand-name biologic’s ASP.
- This bill provides an incentive for providers to use biosimilars, which have an average 30% lower ASP compared to the respective reference biologic.
Incentive for Physicians, Lower Costs for Patients and Savings for Medicare – Cosponsor Increasing Access to Biosimilars Act (S. 1427/H.R. 2869)
- This bill, introduced by Sens. John Cornyn (R-TX) and Michael Bennet (D-CO) in the Senate, and Rep. Tony Cardenas (D-TX) in the House, directs CMS to establish a voluntary, national demonstration project under Medicare Part B to evaluate the benefit of providing a shared savings payment for biosimilars.
- Participating providers would receive a portion of the savings for prescribing a biosimilar with a lower ASP than the reference biologic.
- This program would create a financial incentive to administer biosimilars, guaranteeing savings for Medicare and taxpayers.
Establish a New Specialty Tier for Biosimilars – Cosponsor the Ensuring Access to Lower-Cost Medicines for Seniors Act (H.R. 2846)
- This bill, introduced by Reps. David McKinley (R-WV) and Ann Kuster (D-NH), ensures seniors are able to access and fully benefit from low-cost generics and biosimilars through the Medicare Part D program.
- It would also ensure new generics and biosimilars are covered upon launch, provide that generics are placed only on generic tiers with lower cost-sharing and not higher brand cost-sharing tiers and establish a new specialty tier for biosimilars and specialty generics.
The Biosimilars Council is proud to be a stakeholder resource for information about these three legislative proposals and other efforts to support biosimilar access for America’s patients.
*Updated September 2021
About the Biosimilars Council
The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available on our about page.
AAM is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 22 percent of total drug spending. Additional information is available at www.accessiblemeds.org.