How do biosimilars offer a potential for greater savings and access across the health care system?
In just 5 years, originator biologics were granted
77 new approvals1
And biologic products account for
43% of all US medicine spending2
Could biosimilars help reduce costs to the health care system and help with patient access to biologics?
Evolving the health care system to meet increasing demands
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.
What generics were to the US health care system in the 20th century is what biosimilars have the potential to become in the 21st century.5
As competition increases from biosimilar adoptions, the potential for significant savings to the health care system increases as well.7
Maintaining the balance between innovation and accessibility
Congress passed the Biologics Price Competition and Innovation Act (BPCIA) of 2009 with the goals of 8,9:
Facilitating biosimilar competition
By establishing a pathway to approval
Reducing health care costs
By potentially lowering the overall costs of biologics through the introduction of biosimilars
- By offering greater access to medications
- By expanding payer, provider, and patient choice
US Department of Health and Human Services (HHS) is taking steps to help address the challenges of access to and reimbursement of biosimilars, such as10:
- Improving billing and payment code policies under Medicare Part B
- Revising Medicare Part C and D regulations to help increase access to biosimilars
FDA’s Biosimilars Action Plan8
The FDA has laid out a multifaceted action plan to foster biologic innovation and further biosimilars development. Key measures range from the development and implementation of new FDA review tools to providing revised guidance on biosimilar topics and the establishment of a new Office of Therapeutic Biologics and Biosimilars (OTBB).
Governmental entities are actively engaged in helping to improve adoption of biosimilars across the US health care system.8,9
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.