Biosimilars Bulletin | July 2021

Friday August 6, 2021

Each month, the Biosimilars Council sends a newsletter with the latest updates in the biosimilars industry, including policy movement, educational resources and upcoming events. To stay current on biosimilars, sign up to receive these monthly updates on the form to the right.

A Note from Biosimilars Council Executive Director Christine Simmon

We reached a significant milestone with the FDA’s licensure of the first interchangeable biosimilar. While this is good news, the enduring success of biosimilars is contingent on many factors, and we look forward to continuing to work the FDA and stakeholders to promote patient access to biosimilars. Our full statement is available here.

Earlier this month, a group of 28 diverse key stakeholder organizations representing patients, providers, consumers, business and taxpayers sent a letter to Representatives Kurt Schrader (D-OR) and Adam Kinzinger (R-IL), thanking them for introducing the BIOSIM Act. This legislation is a key step in helping to encourage and promote the growth of biosimilar medicines by fixing misaligned incentives in Medicare Part B. Our recent blog post provides more information on the BIOSIM Act and other legislation that would promote biosimilars.

Additionally, President Biden issued an Executive Order that, among other goals, aims to increase adoption of biosimilars. The Biosimilars Council looks forward to working with the Biden administration to achieve this goal.

Thank you again to everyone who continues to support our efforts. By working together to increase patient access to lower-cost biosimilars, we can provide relief to millions of Americans struggling to afford essential medicines.

– Christine

News & Updates

Biosimilars Council Statement on FDA Approval of First Interchangeable Biosimilar

AAM’s Biosimilars Council applauds the FDA’s decision to award an interchangeable designation to an insulin glargine treatment. This designation allows pharmacists to substitute interchangeable biosimilars for their prescribed reference products without the intervention of the prescriber.

Opinion: How Will Semglee Interchangeable Insulin Affect Access and Affordability?

The approval of Biocon Biologics and Viatris’ insulin glargine product as an interchangeable biosimilar will be a test of whether such designations can make a difference in patient access, Jeff Baldetti, MBA, of Cardinal Health explains. To help pharmacists and pharmacy technicians navigate their state’s specific guidelines and support patients with biosimilar adoption, Cardinal Health partnered with regulatory advisors to develop an interactive map that details state-by-state interchangeability laws, and is available at the following link:

Increase Patient Access to Lower-Cost Biosimilar Medicines

Since the biosimilars pathway (BPCIA) was established in 2010, 29 biosimilars have been approved. However, due to significant barriers to market entry, just 20 biosimilars are available to patients —and even fewer have significant market uptake. Because FDA-approved biosimilars provide market-based competition for costly biologics, this slow market adoption is leaving significant savings on the table for patients and taxpayers. In fact, AAM’s Biosimilars Council found the health care system has lost more than $2.2 billion in savings due to slow biosimilar adoption. Three legislative proposals would help strengthen biosimilar adoption and ensure savings for patients and Medicare.

Congressman Schrader Describes Frustration with Biosimilar Uptake 

Rep Kurt Schrader, D-Oregon, is hoping for a stronger embrace in the health care community of his bill to increase reimbursements for use of biosimilar agents. And more public enthusiasm could persuade the FDA to approve more of these cost-saving biologics, he said. Biosimilars are generally lower-cost agents that can be used in place of costly originator biologic brands, and Schrader and Rep Adam Kinzinger, R-Illinois, have introduced a bill for creation of an act called Bolstering Innovative Options to Save Immediately on Medicines Act (BIOSIM), which would stimulate the use of biosimilars by increasing the add-on incentive payment to physicians who prescribe them.

AAM Calls for a Balance Instead of Banning Pay-For-Delay

US President Joe Biden has signed an executive order asking the FTC to ban so-called “pay-for-delay” reverse-payment settlements. According to the order, this could help curb high prices that are in part the result of lack of competition among drug manufacturers. However, talking exclusively to Generics Bulletin, AAM senior vice president Jeff Francer insists on a balance, explaining that such settlements result in earlier access to biosimilars and generics.

FDA Scolds Amgen Over a Misleading Ad That Could Deter Use of Biosimilar Versions of its Drug

In an embarrassing rebuke, the Food and Drug Administration has scolded Amgen (AMGN) over an advertisement for one of its medicines that made misleading claims and, as a result, might confuse physicians and thwart the use of lower-cost biosimilar versions.

Amgen US Biosimilar Trends Report Highlights Price Discounts

No new biosimilars have been approved so far in 2021, and the number of approvals in 2020 (3) was low compared with previous years; but 6 years after its first biosimilar launch, the United States is ahead of where the European Union was, according to a preview of Amgen’s 2021 Biosimilar Trends Report. Further, biosimilars are launching at deep discounts to reference products and capturing increasing market share, the preview states.

Biden’s Push for More Competition: What’s in the Executive Order 

Biden will also urge the FTC to stop pharmaceutical manufacturers from paying their generic counterparts to delay entry into the market of lower-priced versions of medications. That idea is part of pending legislation in the Senate and aligns with campaign promises Biden made last year.

The Association for Accessible Medicines, the leading trade group for the generic drug industry, said it’s looking forward to working with the Biden administration to increase adoption of lower-cost generics and biosimilars “and remedy the growing number of government and payer policies that perversely reward the use of high-cost brands over generic or biosimilar competitors.”

Patient Advocacy Organizations Join Forces to Endorse BIOSIM Act

To improve biosimilar utilization, 28 patient advocacy organizations penned a letter of endorsement for HR 2815, a House bill that aims to increase Medicare reimbursement for health systems that prescribe biosimilars to patients. The 60 Plus Association, Allergy and Asthma Network, CancerCare and Texas Business Group on Health were among the organizations throwing their support behind HR 2815, also known as the Bolstering Innovative Options to Save Immediately on Medicines (BIOSIM) Act.

Unlocking the Full Potential of Biosimilars

Data science company IQVIA has been watching developments in biosimilars since the first product was licensed in Europe 15 years ago and believes that biosimilars could be a valuable tool in creating more sustainable health care systems. Speaking at a recent virtual event, a collaboration between global biosimilars leader, Sandoz, and Reuters Events Pharma, Murray Aitken, the IQVIA Institute’s Executive Director, said: “We are at a significant point today where we see biosimilars playing a meaningful role in health systems in many countries around the world.”

Organizations Thank Rep. Schrader, Kinzinger for Introducing the BIOSIM Act

Today, a group of organizations representing patients, employers, taxpayers, providers, communities of color and consumer groups sent a letter thanking Representatives Kurt Schrader (D-OR) and Adam Kinzinger (R-IL) for introducing the BIOSIM Act (H.R. 2815). This legislation is critical to reducing costs and improving patient access to biosimilars in the U.S. by providing a temporary increase to physician reimbursement.

New US Legislation Creates Momentum For Biosimilars

Most biosimilars (follow-on biologics products) still only have shares below 50% in the U.S., which is far different than market shares in Europe. One major reason is a mistrust around biosimilars’ safety and efficacy. Congress has stepped in to address that issue through the Advancing Education on Biosimilars Act of 2021, with the goal of encouraging rapid uptake soon after biosimilars become commercially available.

Featured Resources

Biosimilars Gain Traction, Generate Savings

The use of oncology biosimilars has expanded rapidly in the United States during the past 2 years as providers embraced a growing armamentarium of new products, according to findings from real-world data reported at the 2021 American Society of Clinical Oncology Annual Meeting (ASCO 2021). Results of several analyses also show that biosimilars are starting to make an impact on the cost of providing care.

biologics market

Study: Medicare’s Lost Savings Due to Delayed Adalimumab Biosimilar Entry

Medicare would have saved $2.19 billion on adalimumab spending between 2016 and 2019 had biosimilars become available in the years they were approved, according to investigators who identified patent obstacles as the cause.

The Biosimilars Council - Doctor sitting with older patient

July 2020 Data Book: Health Care Spending and the Medicare Program 

The Medicare Payment Advisory Commission’s (MedPAC) annual Data Book provides information on national health care and Medicare spending as well as Medicare beneficiary demographics, quality of care in the Medicare program and Medicare beneficiary and other payer liability. Chapter 10 includes information on prescription drug spending and highlights the savings biosimilars provide.


GRx+Biosims 2021 – November 8-10

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.

For information and updates, click here.

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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The Council is involved in a number of events that focus on advancing biosimilars in the United States. Click on one below to learn more:



October 21–23, 2024 | Rockville, MD

GRx+Biosims™ 2024 is the leading regulatory science and policy event for the U.S. generics and biosimilars industry. Access the most recent information straight from experts at the Food and Drug Administration, grasp the latest policies shaping the industry, and acquire valuable insights to propel your professional development.