We believe that biosimilars could offer significant benefits to the health care system, from increased competition to reduced costs.1,2
Biologic cost challenges
originator biologics were granted
Could biosimilars help reduce costs to the health care system and help with patient access?
How generics did it
In 1984, Congress established the Drug Price Competition and Patent Term Restoration Act (“Hatch-Waxman”) to encourage competition and provide incentives for pharmaceutical innovators to develop new drugs.4 The influence of Hatch-Waxman wasn’t felt overnight.5 Working together now, we may help make an impact with biosimilars sooner.
In 2019 alone, generic drugs saved
the US health care system
We believe biosimilars could be to the 21st century what generics were to the 20th: a paradigm shift that may deliver more competition, increase treatment options, and help lower costs to the health care system.5
Generic share of US prescriptions by year5,6:
- 13% in 1983
- 90% in 2020
Why are biosimilars being introduced—to help reduce biologic costs7
Biosimilars and public policy
Various government bodies have played a role in incentivizing research and driving biosimilar adoption, ensuring a balance between innovation and accessibility.
In 2010, Congress passed the Biologics Price Competition and Innovation Act
to facilitate biosimilar competition, reduce health care costs, and expand choice and access to medications8,9
The Department of Health and Human Services (HHS) is taking steps to help address the challenges of access
to and reimbursement of biosimilars, such as improving billing and payment code policies under Medicare Part B and revising Medicare Part C and D regulations10
The FDA has laid out a multifaceted action plan to foster biologic innovation
and biosimilars development, including developing and implementing new review tools and establishing a new Office of Therapeutic Biologics and Biosimilars (OTBB)8
The future of biosimilars looks bright
Want more in-depth biosimilar education?
Interactive educational resource for anyone interested in understanding the biosimilars landscape.
Biosimilars question and answer guide
Guide that explains what biosimilar medicines are, how they compare to originator biologics, and how they are approved.