Biosimilars Bulletin | January 2023

Friday February 3, 2023

A Note from Biosimilars Council Executive Director Craig Burton

This year has begun where last year ended – with high attention on biosimilars by policymakers and the public. The launch of the first biosimilar adalimumab has focused attention on the biosimilars market and created an opportunity to set the record straight and emphasize the track record of biosimilar safety and savings.

We expect this scrutiny to only increase, and the Biosimilars Council will be closely engaged in educational efforts on biosimilars and adalimumab. The Council will be emphasizing that biosimilars deliver savings and expand access for patients. And although we expect the adalimumab market to take time to evolve as a result of staggered market entry dates, multiyear formulary contracts, as well as issues unique to this market, we expect biosimilars to deliver savings in the adalimumab market just as they have elsewhere.

As part of these efforts, we’ve been collaborating on a variety of resources to continue to tell the biosimilars story. Stay tuned for more next month.

These and other market, policy, and regulatory developments will be the focus of discussions at our annual conference, Access! 2023, February 13-15 in Orlando, Florida. We are excited to share that entrepreneur Mark Cuban, founder of the Mark Cuban Cost Plus Drug Companywill be a keynote speaker along with Jacqueline Corrigan-Curay, JD, M.D., Principal Deputy Center Director, Center for Drug Evaluation and Research, FDA; and Cynthia Meiners, Senior Vice President at GoodRx. In addition, we’ll have speakers from IQVIA, Mayo Clinic, EmsanaRx, and more.

Immediately after Access! 2023, and in the same location, we will host IGBA’s 25th Annual Conference to bring together top experts from around the world to chart a path forward for the generic and biosimilars industries. Sign up for both of these conferences here.

This is an exciting time for biosimilar medicines, and we look forward to the progress to come.

Craig Burton

News & Updates

Amgen pricing for its Humira biosimilar may benefit PBMs and insurers more than patients

The drug company will offer its medication, called Amjevita, at two different discounts — 5% and 55% — off the roughly $80,000 wholesale, or list, price. The maneuver reflects the behind-the-scenes negotiations that occur between pharmaceutical companies and the pharmacy benefit managers, or PBMs, that create formularies, or lists of medicines for which insurance coverage is provided.

America’s best-selling drug finally goes generic

After 20 years and $200 billion in revenue, Humira — an injectable treatment for autoimmune conditions like rheumatoid arthritis — is losing its monopoly. Its new competitors: at least eight drug companies producing close knockoffs of Humira known as biosimilars. The first debuts next week — others later this year.

Biosimilar Market Outlook Looks Strong

Overall, though the acceptance of biosimilars in the United States is relatively slow compared with the European Union, the pace is increasing. This trend is expected to continue, with a projected savings of up to $133 billion through biosimilar use in the United States by 2025. The launch of biosimilars and their use in US health care facilities has reduced biologic medications spending and improved overall health system financial sustainability.

California Joins Others In Suing 3 Drug Firms For High Insulin Prices

Explaining recent soaring prices for a drug long off patent, critics said that between them, the three major pharmaceutical players have stifled competition. They also point to a host of patent law maneuvers, including companies tweaking aspects of insulin’s formulation or how it is administered, such as through injector pens, to expand lucrative patent protection on branded insulin products.

The Big Three PBMs’ 2023 Formulary Exclusions: Observations on Insulin, Humira, and Biosimilars

Formulary exclusions have emerged as a powerful tool for PBMs to gain additional negotiating leverage against manufacturers. The prospect of exclusion leads manufacturers to offer deeper rebates to avoid being cut from the formulary. Exclusions are one of the key factors behind the large gap between list and net prices for brand-name drugs

Featured Resources

Biosimilars in the United States 2023-2027

In this report, the current state of the biologics market in the United States and share of the market facing biosimilar competition are assessed. Factors impacting biosimilar uptake, including reimbursement and provider type, and the impact of biosimilars on molecule volume and price are evaluated. Historic biosimilar trends are utilized to provide potential future biosimilar spending and savings scenarios.

Study Finds Middlemen Increasingly Block Patient Access to New Generics

America’s patients and health care system rely on generic medicines. Generics reduce costs, expand access to care, and result in greater patient adherence — ultimately keeping patients healthy and productive. This track record of success is jeopardized by market abuses that delay patient access to new generics. To realize the full value of new generic competition, as well as savings from new biosimilar medicines, policymakers at CMS and in Congress must ensure rapid plan coverage of new generics and biosimilars.

The Global Use of Medicines 2023 

The largest driver of medicine spending through the next five years is still expected to be global COVID-19 vaccinations, but leaving aside the pandemic, global spending on medicines continues to be driven by innovation and offset by losses of exclusivity and the lower costs of generics and biosimilars.


Access! 2023 – AAM Annual Meeting – February 13-15, 2023 (Orlando, Florida)

Last chance to register! This year, Mark Cuban, the founder of Mark Cuban Cost Plus Drug Company, will be joining attendees for a Fireside Chat. The conference provides ample opportunities to meet the leaders and decision-makers who are shaping the future of generics and biosimilars. Be inspired by new experiences, real talk and fresh ideas during a period of intense challenges and exciting promise. Join generic and biosimilar industry professionals at Access! 2023. Learn more.

25th IGBA Annual Conference hosted by the Association for Accessible Medicines (AAM) – February 15-16, 2023 (Orlando, Florida)

Last chance to register! Come join your colleagues from around the world to network and discuss challenges and opportunities for the global generics and biosimilars industries. For the first time since 2014, IGBA’s Annual Conference is being held in the United States, in conjunction with AAM’s Access! 2023 Annual Meeting. Learn more and register today.

Festival of Biologics – March 20-23, 2023 (San Diego, CA)

This year, AAM and its Biosimilars Council are official partners of the Festival of Biologics! This event, held in San Diego, California, gives you the opportunity to share research, create new partnerships, and tackle the clinical trials, manufacturing and commercial challenges involved in bringing new therapies to market. Register now!

Want to hear directly from Executive Director Craig Burton?

Follow him on LinkedIn

Interested in joining the Biosimilars Council?

Contact Jewel Smith ( for more information.

Stay Informed

Subscribe for Updates

Receive our monthly Biosimilars Bulletin and other important updates on biosimilars in the U.S.


Get Involved

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.