Biosimilars Bulletin | July 2020

Monday August 3, 2020

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.

News and Updates

Increasing Access to Biosimilars Act

The Biosimilars Council commends Senators Cornyn and Bennet for the introduction of the Increasing Access to Biosimilars Act. This bipartisan proposal is based on a simple idea – that Medicare policies should encourage the use of the most effective, lowest-cost medicine.

3 P’s in A Pod: Keys for Building A Successful U.S. Biosimilars Market

Biosimilars Development Editor Anna Rose Welch explores the keys for building a successful biosimilars market, a significant topic of discussion at the BIO International Convention.

U.S. Oncology’s Rifkin Explains Rituximab Uptake

Rituximab is a drug with efficacy for rheumatoid arthritis and other autoimmune diseases and its biosimilar form is catching on, thanks to a variety of factors, not the least of which is an effort by physicians to promote biosimilar use, Robert M. Rifkin, M.D., a medical oncologist and hematologist with Rocky Mountain Cancer Centers in Denver, told The Center for Biosimilars.

Use of Infliximab Biosimilar in Medicare Population Is Low but Growing, Study Finds

Analyzing by prescribing clinician, the authors found gastroenterologists prescribed the biosimilar less often (14%) compared with the reference product (17%), while oncologists prescribed the biosimilar more commonly (10.5%) than the reference product (5.5%). Rheumatologists prescribed the biosimilar and reference product in the same proportions (58.2% and 59.9%, respectively).

Biosimilars Face High Expectations, But Also Barriers to Acceptance

Practitioners should expect that payers will mandate multiple switches to biosimilar tumor necrosis factor inhibitors (due to the cost benefits of these therapies, which so far appear to yield similar efficacy and safety outcomes to originator anti-TNFs, said Alan Moss, M.D., at the virtual 2020 Advances in Inflammatory Bowel Disease (AIBD) meeting.

FDA Says New System for Calculating Biosimilar Fees Is Reliable

In an update on progress made on changing the methodology for calculating biosimilar drug review fees, the FDA said a new system would enable it to better plan for variation in workloads and have the resources available to do an effective job.

Sandoz Reviewing Options After Federal Circuit Upholds Lower Court Ruling in Biosimilar Erelzi Case

Sandoz announced the U.S. Court of Appeals for the Federal District has ruled against Sandoz in patent litigation concerning its etanercept biosimilar. The decision upholds a prior ruling from the New Jersey District Court, which declared the Amgen patents valid. Sandoz is evaluating its options, which may include an appeal to the U.S. Supreme Court.

FDA Approves Humira Biosimilar

A sixth biosimilar version of Humira has been approved by the U.S. FDA. However, all of these adalimumab biosimilars face a wait until 2023 before they can enter the market.

Part 1: Christine Simmon Discusses the Individual Mandate and Biosimilars

Executive Director Christine Simmon discusses potential legislation that AAM is advocating for and how the upcoming election and Supreme Court decision will affect biosimilars.

Part 2: Christine Simmon Discusses Payer Influence on Provider Behavior

Executive Director Christine Simmon discusses the new pathway for insulin biosimilars and the struggles between payers and providers over biosimilar choice.

Featured Resources

The Importance of Countering Biosimilar Disparagement and Misinformation

A new white paper from Hillel Cohen and Dorothy McCabe found that biosimilar use is limited in some health care systems because biosimilars are not well understood by many health care professionals and patients.

Key Lessons for the US From EU

New Resource: Lessons for the United States on Europe’s Biosimilar Experience

A decade after the United States established its own biosimilars pathway, this new white paper discusses that we are past time to move beyond this outdated perception and consider what the United States can learn from Europe’s experience with biosimilars.

FDA-approved biosimilars

New Resource: Biosimilars Approvals and Launches

A comprehensive resource on the latest FDA-approved biosimilars, including launch dates where applicable.

patient access to biosimilars

Increase Patient Access to Lower-Cost Biosimilar Medicines

The three legislative proposals outlined in this one-pager would help strengthen biosimilar adoption and each is designed to ensure savings for patients and Medicare.

biologics market

Biosimilars in the Pharmacy Benefit Action Brief

This new resource from the National Alliance of Healthcare Purchaser Coalitions provides action steps for employers to drive biosimilar use and transparency.

alternative to biologic medicines

Infographic: Patients Have an Alternative to Expensive Biologic Medicines

Patients have an alternative to expensive biologic medicines. This new infographic highlights what patients need to know about biosimilars and how to increase access to these safe treatment options.

biosimilars benefit everyone

Infographic: Biosimilars Benefit Everyone

Biosimilars benefit everyone. This new infographic shows how we all — doctors, payers, and patients — can benefit from biosimilars.

Upcoming Events

GRx+Biosims 2020

November 9-11, 2020

For the first time ever, access the premier scientific and regulatory event for the generic and biosimilar medicines industry from the comfort of your home or office. Web stream the conference and get the information, insights and experience you expect from GRx+Biosims, plus participate in Q&A with speakers, have one-on-one meetings with exhibitors and network with peers.


About the Biosimilars Council

The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available on our about page.

About AAM

AAM is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 23 percent of total drug spending. Additional information is available at

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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:



Registration Opens Soon. October 21–23, 2024 | Rockville, MD

GRx+Biosims™ 2024 is the premier 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.