Biosimilars Access and Affordability Act
- Sponsor
- Sen. Blackburn, Marsha [R-TN]
- Committees
- Finance Committee (primary)
- Last action
- Sep 28, 2026
Bottom line
The bill aims to incentivize biosimilar development and market entry by temporarily shielding reference biological products from Medicare price negotiations, with a safeguard to recover funds if biosimilars fail to launch.
What it actually does
This bill amends the Social Security Act to change the eligibility rules for Medicare drug price negotiations for biological products. It introduces an automatic 2-year delay in price negotiations for a reference biological product if a biosimilar version is expected to be marketed within that timeframe. The bill also establishes a rebate mechanism, requiring the manufacturer of the reference product to pay back Medicare if the expected biosimilar does not materialize and launch within the specified 2-year period.
Proponents argue
Proponents argue that delaying price negotiations for a limited period will provide crucial incentives for biosimilar manufacturers to invest in and bring their products to market. They contend that robust biosimilar competition is the most effective long-term strategy to drive down drug costs, offering more sustainable savings and broader patient access to affordable medicines than direct government negotiation alone.
Opponents contend
Critics may argue that this bill delays the immediate cost savings that Medicare could achieve through direct price negotiations, potentially increasing costs for the program and beneficiaries in the short term. Concerns could also be raised about the criteria for determining an 'expected marketing' date and the potential for manufacturers to strategically use the delay without a firm commitment to biosimilar launch.
The bill is short and focused, making it accessible for a reader to understand its core changes to Medicare drug price negotiation rules.
Section 2(a)(2)(B)(i) and (f)(1)(B)(i) of the bill, amending Section 1192(f) of the Social Security Act.
Automatic Delay for Reference Biological Products
This provision mandates an automatic 2-year delay in Medicare price negotiations for a reference biological product if a biosimilar for it has an accepted application or ongoing clinical studies, and is expected to be marketed within 2 years of the reference product's selection date. This aims to create a window for biosimilar market entry before the reference product's price is negotiated, fostering competition.
Supporters argue
Supporters argue this automatic delay removes uncertainty for biosimilar developers, encouraging them to invest in and bring more biosimilars to market. This increased competition will ultimately drive down drug costs more effectively and sustainably than direct government negotiation alone.
Critics contend
Critics might argue that this provision delays the immediate savings Medicare could achieve through price negotiations, potentially costing the program and beneficiaries more in the short term. They may also express concern about the criteria for 'expected marketing' and potential for manipulation.
Tradeoffs
The bill balances the immediate savings from Medicare price negotiations against the potential for greater, more sustainable savings from robust biosimilar competition. It trades short-term negotiation benefits for long-term market-driven price reductions.
Section 2(a)(2)(B)(ii) of the bill, amending Section 1192(f)(2)(B) of the Social Security Act.
Manufacturer Rebate for Unmarketed Biosimilars
If a reference biological product receives a 2-year delay from price negotiations due to an expected biosimilar, but that biosimilar is not licensed and marketed within 2 years, the manufacturer of the reference product must pay a rebate to Medicare. This rebate aims to recover the savings that would have occurred had the price negotiation not been delayed.
Section 2(a)(3) of the bill, adding new subsection 1192(g) to the Social Security Act.
Clarification of "Marketed"
This section defines "marketed" as a drug or biological product (including a biosimilar) being "introduced or delivered for introduction into interstate commerce." This clarifies the specific action required for a biosimilar to be considered "marketed" for the purposes of the delay and rebate provisions, ensuring consistent application of the law.
This clarification states that the existence of pending or prospective patent litigation over a biosimilar biological product shall not preclude the automatic delay in price negotiations or a finding of "high likelihood" for biosimilar marketing.
Section 2(a)(2)(A)(iii)(II)(bb) and (C)(C) of the bill, amending Section 1192(f)(1)(B) and (f)(3) of the Social Security Act.
Why it matters:This is standard legislative practice to address specific legal or practical hurdles that might otherwise complicate the application of the main policy. It ensures the intent of the delay—to promote biosimilar market entry—is not undermined by common industry practices like patent disputes.
Case for: Proponents argue this clarification is essential to prevent patent disputes from being used as a tactic to indefinitely delay biosimilar market entry and thus Medicare price negotiations. It reinforces the bill's goal of promoting biosimilar competition by separating market entry incentives from patent battles.
Case against: Some might argue that ignoring patent litigation could create uncertainty for manufacturers, potentially leading to market entry disputes or legal challenges, though the bill's intent is to separate market entry from patent resolution for the purpose of price negotiation delays.
Estimated impact: This provision removes a significant potential barrier to the application of the delay mechanism, potentially affecting numerous biological products subject to patent challenges and streamlining the process for biosimilar market entry.