Biosimilars Bulletin | October 2021

Wednesday November 3, 2021

A Note from Biosimilars Council Executive Director Christine Simmon

This month, the Biosimilars Council announced the release of AAM’s 2021 Generic Drug and Biosimilars Savings in the U.S. report. We are proud to note that biosimilars helped to cut the oncology spending growth rate nearly in half from 2019 to 2020. The report also finds biosimilars created $7.9 billion in savings in 2020, a three-fold increase over 2019. Overall, it shed light on many positive trends, and we look forward to seeing further growth for biosimilar medicines.

Indeed, opportunities to increase biosimilars utilization were highlighted in the Center for Medicare and Medicaid Innovation’s “strategic refresh” released this month, featuring the potential of a shared savings program – a Council advocacy priority – to drive greater patient uptake.

Looking ahead, we are excited for the GRx+Biosims 2021 conference taking place November 8-10, where we will discuss the positive news from the savings report and the future of biosimilar medicines in the United States. This year’s event will be held virtually. Don’t forget to register for this premier event here. To learn about sponsorship opportunities, please contact us through this form.

Last, the second annual Global Biosimilars Week, a globally aligned educational initiative to raise awareness for biosimilars worldwide, is happening now. Use the social toolkit to draft content and join the conversation on social media throughout this week to help us promote biosimilars.

— Christine

News & Updates

Patients Increasingly Rely on Oncology Biosimilar Medicines

Biosimilar medicines are increasingly becoming an essential fixture in health care, reducing prices and increasing patient access. This is especially true for oncology treatment, where biosimilar medicines are helping expand access to care for cancer patients across the country. The 2021 Generic and Biosimilar Medicines Savings Report illustrates the growth in utilization of oncology biosimilars and resulting savings for patients. In 2020, increased adoption of biosimilars bent the curve in oncology spending, cutting the growth rate roughly in half since 2019. Together, biosimilar and generic medicines generated $16 billion in oncology savings in 2020, up from about $13.5 billion in 2019.

FDA Will Take Action On Biosimilars Delayed By Inspection Lag

With multiple US biosimilar applications held up by the FDA’s inability to conduct necessary inspections in the context of the COVID-19 pandemic, the agency tells Generics Bulletin that it is “actively working” on a solution.

A Policy Roadmap to More Affordable Biologic Treatments

Despite the proven benefits and delivering $7.9 billion in savings in 2020 alone, biosimilar adoption in the U.S. has been slower than anticipated, largely due to misinformation, prescriber hesitancy, and a lack of common-sense policies that properly incentivize the use of these biologic medicines.

While recent action from the Biden administration and Congress demonstrates a growing acknowledgement of the value of biosimilars, more can and must be done to improve patient access to these high-quality, more affordable and equally efficacious biologic medicines.

CMMI Rolls Out Strategic Refresh to Make Payment Models More Equitable and Streamlined

The Biden administration issued a strategic plan Wednesday to make value-based care payment models more equitable and streamlined to foster more participation from providers and patients over the next decade. Officials with the Center for Medicare and Medicaid Innovation (CMMI) introduced the strategic refresh, which will inform how models are evaluated and crafted by the center over the next decade. Key goals of the refresh include judging the success of models not just on whether they save Medicare money but also whether they improve health equity.

FDA Approves Cyltezo, the First Interchangeable Biosimilar to Humira

The U.S. Food and Drug Administration approved the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm), originally approved in August 2017, is both biosimilar to, and interchangeable with (may be substituted for), its reference product Humira (adalimumab) for Cyltezo’s approved uses. Cyltezo is the second interchangeable biosimilar product approved by the agency and the first interchangeable monoclonal antibody.

AAM Annual Savings Report – Biosimilars and Bending the Cost Curve

Since the enactment of the Biologics Price Competition and Innovation Act in 2010, patients with complex disease have been eager to access biosimilar therapies and the savings they provide. New data show that biosimilars’ savings are both real and growing. The 2021 U.S. Generic and Biosimilar Medicines Savings Report released by the Association for Accessible Medicines (AAM) and shared by the Biosimilars Council found biosimilars have generated $12.6 billion in savings over the past 10 years.

Biosimilar Growth Impressive But New Policies Needed, AAM Exec Says

The prescribing of generic drugs and biosimilars that are less expensive than their brand-name counterparts saved the U.S. healthcare system almost $340 billion in spending in 2020 according to the Association for Accessible Medicines (AAM), a trade association for generic and biosimilar makers.

The AAM said that biosimilar drugs saved $7.9 billion in 2020, more than tripling the $2.5 billion saved in 2019. “This growth demonstrates prescriber and payer confidence in the safety and efficacy of FDA-approved biosimilars and their ability to provide greater access to treatments at a savings for patients,” Christine Simmon, executive vice president of policy and strategic alliances at AAM and executive director of the organization’s Biosimilars Council, told Managed Healthcare Executive®.

Biosimilars Competition Helps Patients More Than Generic Competition

A notion in the policy community is that competition between biologics and their biosimilars does not save patients and taxpayers as much as well-functioning generic competition for regular pharmacy-based small-molecule drugs. But we argue that the evidence shows the opposite: Biosimilar competition produces greater savings per drug than generic competition.

Opinion: The “Forgotten Molecules” May Reward Biosimilar Developers

There are hundreds of potential biosimilar candidates that can be brought to the market readily to expand into the untapped market of biosimilars without significant patent challenges and producing significant revenue. Not least of the advantages is fulfilling the dire need for affordability. Yet, with over 100 biosimilars approved in the European Union and United States, we can see a trend that all companies are running after the market leaders like adalimumab. There is even a bigger market potential available in the forgotten molecules. Of the 83 biosimilars candidates, whose patents have expired, only 18 molecules are approved in the European Union and 11 in the United States (Figure). Antibodies lead the list of over 100 approved biosimilars. It is about time that we find the hidden biosimilar gems and expand the market of diseases treated with biosimilars.

Featured Resources

The 2021-22 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

The Drug Channels Institute announced an exclusive analysis of prescription channels in the United States. Their new 2021-22 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors provides the first public analysis of the market impact of biosimilars on wholesalers, finding that biosimilars bring higher profit to drug distributors and states.


Second Annual IGBA Global Biosimilars Week: Advancing Access — November 1-5

Join the Movement! Global Biosimilars Week (GBW) is an awareness campaign coordinated by the International Generic and Biosimilar Medicines Association (IGBA). As an IGBA member, AAM and the Biosimilars Council invite you to “join the movement” and share biosimilar content in your own social media channels using daily themes and the hashtag #globalbiosimilarsweek. Learn more.

GRx+Biosims 2021 — November 8-10

Last Week to Register! GRx+Biosims 2021 is the premier scientific and regulatory event for the U.S. generics and biosimilars industry. With timely programming relevant to technical, regulatory and policy professionals, GRx+Biosims 2021 brings together top officials and subject matter experts to share their knowledge and best practices to enhance attendees’ understanding of generic and biosimilar development, regulatory process and approvals, and the evolving policy landscape.

To register, click here. Follow the hashtag #GRxBiosims for conference updates on social media.

Want to hear directly from Executive Director Christine Simmon?

Follow her on Twitter @CSimmon_DC

Interested in joining the Biosimilars Council?

Contact Jewel Smith ( for more information.

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Register Now! February 5–7, 2024 | Tampa, Florida

AAM’s annual meeting Access! 2024 brings together policymakers, influential speakers and industry leaders to chart the future of generics and biosimilars. Discussions center around the business, breakthroughs and politics that shape our industry. It’s the opportunity to hear firsthand from world-renowned speakers and learn about where our industry is heading and what our future holds.