Biosimilars Bulletin | November 2021

Monday December 6, 2021

A Note from Biosimilars Council Executive Director Christine Simmon

The second annual Global Biosimilars Week proved a great way to kick off November! Once again, dozens of organizations and individuals from around the world came together to raise awareness for biosimilars. Thank you to our Council members and everyone who participated in this dynamic educational social media campaign!

Also, this month the Association for Accessible Medicines and Biosimilars Council hosted the GRx+Biosims 2021 conference, the premier scientific and regulatory event for the U.S. generics and biosimilars industry. Leading industry experts and government officials interacted with 422 virtual attendees in 32 presentations and panels over three days.

I was particularly encouraged by the discussion from the event I moderated, the Manufacturers’ Roundtable, where executives from leading biosimilar manufacturers discussed the progress achieved and the path ahead to greater biosimilar sustainability. The roundtable and the entire slate of programming leaves me confident the biosimilars industry, if given the chance, will build upon the strong foundation for competition and generate more savings for patients.

However, the Build Back Better Act that is currently under consideration in Congress includes drug pricing reforms that would undermine patients access to affordable, FDA-approved biosimilar medicines. We encourage everyone who cares about access to biosimilars and generics to make their voices heard by telling lawmakers to oppose the Build Back Better Act. Send a message to your Senator now.

From Global Biosimilars Week and GRx+Biosims 2021 to our advocacy efforts, thank you to everyone who continues to help advance biosimilars for patients. We’re looking ahead to Access! 2022, AAM’s annual meeting February 14-16 in Orlando, Florida. Remember to register by December 31 and save $500 off your full-pass registration. We hope to see all of you in person then.

— Christine

News & Updates

GRx+Biosims 2021 Conference Recap

AAM’s 2021 GRx+Biosims conference has officially come to a close, and by all accounts it delivered on its promise to provide attendees informative and timely discussions on the direction of the biosimilars industry. The many expert panelists brought insightful viewpoints about the biosimilars landscape and the opportunities to continue expanding this critical industry.

The BBB’s Threat to Biosimilar Drug Development

Democrats have included a number of provisions intended to reduce drug prices in the Build Back Better bill, which is currently being debated in the U.S. Senate after having passed the House of Representatives. But the fact is the current bill’s provisions that call for Medicare to essentially regulate prices and limit any future price increases would come at a high cost.

For starters, it would completely upend our country’s wildly successful decades-long model of allowing new drugs to enjoy short periods of exclusivity, followed by a period of robust competition from generics and—for large molecule biologic drugs—biosimilars.

AAM Panel of Manufacturers Says Drug Price Rebates Must Go

How do biosimilar manufacturers feel about drug price rebates that obscure the true costs of medicine? Drug price rebates negotiated between manufacturers and drug middlemen such as pharmacy benefit managers would have been halted under a policy sought by the former Trump administration; however, this initiative has been put on the back burner by President Joe Biden.

FDA Touts Success and Challenges in Biosimilar Development

A top official from the US Food and Drug Administration (FDA) offered a mixed assessment of the agency’s biosimilars program, noting that although the program is growing, there is more uptake of the program in the oncology space, with less activity in other treatment areas. The costly and lengthy process of getting biosimilars approved is also a deterrent to wider uptake.

Dr. Jacqueline Corrigan-Curay, principal deputy center director for FDA’s Center for Drug Evaluation and Research (CDER), made these observations in her update on the biosimilar development program in her CDER keynote address at the 8 November meeting of the Association for Accessible Medicines’ (AAM) GRx+Biosims conference.

A Toxic Drug-Price Deal

Generic manufacturers on average spend $100 million to $250 million to bring a biosimilar to market. They won’t invest that much if the government may later undercut them by imposing lower prices on branded drugs. Government discounts might reduce prices that Medicare pays on some drugs, but overall drug prices will stay higher if investment in new generics diminishes.

FDA’s Woodcock Says Agency Has Resumed Normal Review Pace for Biosimilars, Generics

Janet Woodcock, MD, acting commissioner of the FDA, delivered an upbeat report on biosimilars and generics progress as keynote speaker of the Association for Accessible Medicines’ GRx+Biosims annual conference this week. She addressed the HHS recommendations for pricing reforms in the drug industry, noting that many patients are not adhering to their medications because of high prices, and also said that, now that COVID-19 pandemic is more under control, the FDA is returning to business as usual, addressing applications for biosimilar and generic approvals and conducting domestic factory inspections in a normal fashion.

The Hurried Push by Congress to Address Drug Costs Shouldn’t Undermine the Vast Savings from Generics and Biosimilars

Americans rightfully expect Congress to address the ever-increasing prices of brand-name prescription drugs. But the wholesale policy changes now under rushed consideration in Congress will undermine the only proven solution to this long-standing problem: competition from Food and Drug Administration-approved generic and biosimilar medicines.

Pharmacy Policy Experts Describe Changes in Biosimilar Adoption Curve

“Authorized biologics” have been conceptualized as products that might one day compete with biosimilars, but although this hasn’t happened so far, the first authorized biologics are on the horizon, according to pharmacy analysts who spoke at the recent Academy of Managed Care Pharmacy (AMCP) Nexus 2021 meeting.

Featured Resources

The Worldwide Biosimilars Industry is Expected to Reach $44.7 Billion by 2026

The global biosimilars market is projected to reach USD 44.7 billion by 2026 from USD 15.6 billion in 2021, at a CAGR of 23.5% during the forecast period of 2021 to 2026. Market growth is largely driven by the rising incidence of chronic diseases and increasing demand of biosimilars for their cost-effectiveness. Regulatory approvals and other regulations favoring biosimilars adoption in different countries is also a major driving factor in the biosimilars market.


Access! 2022 – February 14-16, 2022 (Orlando, FL)

Register by December 31 and save $500 off your full-pass registration! AAM’s annual meeting Access! 2022 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 first hand from world-renowned speakers and learn about where our industry is heading and what our future holds. Learn more.

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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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.