The potential
of biosimilars

We believe that biosimilars could offer significant benefits to the health care system, from increased competition to reduced costs.^1,2

Biologic cost challenges

In just 5 years,
originator biologics were granted

77new approvals³

(2015-2020)

Biologic products account for

43%

of all US and medical spending¹

(2019)

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

~$313 BILLION⁶

We believe biosimilars could be to the 21^st century what generics were to the 20^th: 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 year^5,6:

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 medications^8,9

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

When the health care community works together to achieve mutually beneficial goals, great things can happen. Biosimilar adoption could help improve competition, lower health care system costs, and expand choice and access to biologic medications.