Where Biosimilars Are Headed in the U.S.

The biosimilars landscape is entering a time of remarkable change. Today, there are 28 FDA-approved biosimilars, 18 on the U.S. market, and more on the way. The U.S. marketplace with biosimilars is seeing substantial growth, which has resulted in significant savings and a greater degree of flexibility of choice for both patients and healthcare providers. Amgen's seventh edition of its Biosimilar Trends Report, released on October 13, highlights the current state of the market, upcoming trends, key policy and reimbursement considerations, and more.

For those who may not be aware, a biosimilar is a biological product that is both highly similar to, and has "no clinically meaningful differences" from, an existing and already approved biologic medicine (often called a reference product). Biosimilars are FDA-approved for a subset or all of the same indications as their respective reference products, and healthcare providers and patients can trust that there are no clinically meaningful differences in safety or efficacy between a biosimilar and its reference product. Building on decades of expertise in the innovation and manufacture of biologic medicines, Amgen has a robust portfolio of 10 biosimilars, with four that are FDA-approved and the others in development.

Here's a closer look at some of the key findings from the latest Biosimilar Trends Report, along with insights from Chad Pettit, executive director, Marketing and Global Biosimilars Commercial Lead for Amgen's Biosimilars Business Unit.

The U.S. marketplace with biosimilars is showing steady growth

The rate of growth in FDA biosimilar approvals is showing a clear and positive trend in recent years, ranging from only one approval in 2015 to 10 approvals in 2019. Over the past year, there has been a 65% increase in the number of approved biosimilars and a 157% increase in available biosimilars in the U.S.

"This consistent growth year-over-year shows that the FDA's approach is working and allowing companies to make biosimilars available to patients," Pettit says.

Optimism about the rate of growth in the biosimilars market is shared by industry analysts like Ronny Gal, senior analyst at Bernstein Research, whose latest report states that the marketplace with biosimilars is "growing quickly," and suggests the future looks even more promising.¹ A September 2020 Bernstein analysis reported cost savings from biosimilars in the U.S. annualized at $5.6 billion by the end of the second quarter of 2020, and they are expected to reach nearly $6.5 billion by the end of 2020.

Competition on a level playing field is working

The FDA has demonstrated a commitment to helping the U.S. achieve and maintain a strong marketplace with biosimilars that fosters competition on a level playing field, among originator biologics and biosimilars. The Trends Report states that current U.S. regulatory standards for developing and approving biosimilars, as well as for establishing interchangeability, are robust and scientifically appropriate to protect patient safety and support provider and payer confidence.

"What we see is that biosimilars are doing exactly what they were intended to do, which is creating cost savings through competition with both reference products and other biosimilars," Pettit says. "It's this competition on a level playing field that will continue to create cost savings for patients and for healthcare systems over time."

Education is key to encouraging proper use

The Trends Report underscores the importance of continuing to provide education on what biosimilars are and how they work—along with information about the potential cost savings they may provide—to drive proper use and fully realize their promise.

A 2018 survey from PricewaterhouseCoopers, cited in the Trends Report, found that 55% of clinicians surveyed were unfamiliar with biosimilars, while 65% said they would be more willing to prescribe biosimilars if there was a meaningful cost difference for their patients. Addressing knowledge gaps like these—not only among physicians, but also patients, payers and other key stakeholders—will be key to supporting biosimilar acceptance and use. "Education about the efficacy, safety, potential cost savings, and importance of high-quality and reliable supply of biosimilars can help build the confidence needed for stakeholders across the healthcare system to enable uptake," Pettit says. 

"Resources like the FDA or Amgen's BioEngage are examples of good, credible tools that people can look to for scientifically accurate information about biosimilars."