Your Biosimilars Bulletin | 2021 Year in Review

A Note from Biosimilars Council Executive Director Christine Simmon

2021 proved to be an eventful year for the biosimilars community, with many milestones and positive developments to highlight. Below, you will find policy, regulatory and other developments throughout the year that strengthened patient access to biosimilars.

At the Biosimilars Council, we were proud to bring our industry and stakeholders together to discuss biosimilar developments and trends at AAM’s Access! 2021 and GRx+Biosimilars 2021 conferences. We also illustrated the progress of biosimilar growth and the benefits for patients with the release of the 2021 U.S. Generic and Biosimilar Medicines Savings Report, which found biosimilars providing nearly $8 billion in savings in 2020. In addition to our actions to foster community and demonstrate the growth of the industry, our advocacy efforts earlier in the year contributed to the Advancing Education on Biosimilars Act becoming law, a critical step toward ensuring that clinicians and patients have accurate information about biosimilars, ultimately driving greater adoption of these products. All these measures would not have been possible without the help from stakeholders and members of the Biosimilars Council.

As we come the close of 2021, we are focusing our advocacy efforts to modify the Build Back Better Act to ensure patients can continue to benefit from a competition-based marketplace for biologic medicines. This legislation aims to lower drug prices, but in its current form would jeopardize the savings and increased options for care that biosimilars provide for patients. You can take action today to ensure that patients have access to biosimilars in the years to come.

We are looking ahead to Access! 2022, AAM’s annual meeting February 14-16 in Orlando, Florida. Join us to hear from the leaders driving the future of the biosimilars industry. We hope to see all of you in person then.

— Christine

2021 Key Moments for Biosimilars

January

• The Center for Medicare & Medicaid Services announced its decision to update Medicare Part D and allow plans to adopt a second, preferred specialty tier with lower cost-sharing, which is a step in the right direction for greater biosimilars adoption

February

• AAM released a white paper, Securing Sustainable Markets, examining the challenges to market sustainability for generic and biosimilar medicines. It found that, among other policy solutions, Medicare modernization is key for biosimilars to achieve greater market sustainability.

March

• IQVIA released a report that reinforced the need and potential for straightforward policy proposals to encourage physicians in all settings of care to leverage biosimilar competition for their patients

April

• The Advancing Education on Biosimilars Act of 2021 was signed into law, officially authorizing the Food and Drug Administration to educate consumers and health care providers on the benefits of biosimilar medications.
• Reps. Kurt Schrader (D-OR) and Adam Kinzinger (R-IL) reintroduced the bipartisan BIOSIMS Act. This legislation addresses one of the barriers to greater biosimilars adoption by providing a temporary increase in reimbursement (ASP+8%) to clinicians when they use a biosimilar.
• Senators John Cornyn (R-TX) and Michael Bennet (D-CO) introduced the Increasing Access to Biosimilars Act, which would take a critical step toward enhancing patient access to biosimilars through the creation of a voluntary, shared savings demonstration program in Medicare Part B.

May

• At Access! 2021, the annual meeting for the generics and biosimilars industry, the Biosimilars Council coordinated sessions for industry leaders to gather and share their knowledge and ideas within this growing industry.
• The Voices of Access report for the first the time featured stories from three different biosimilars patients, Jeni, Helen and Akiami, bringing patient perspectives to the BiosimilarsCouncil’s work and reinforcing our mission.

June

• The Supreme ruled in California v. Texas in favor of the Affordable Care Act’s inclusion of a biosimilar pathway, ensuring America’s patients and taxpayers can continue to benefit from biosimilar access and competition in the marketplace.

July

• The FDA approved the first interchangeable biosimilar. Interchangeability allows pharmacists, subject to state law, to dispense a biosimilar when a reference product is prescribed without the intervention of the prescriber. This provides pharmacists with a greater ability to dispense biosimilar medicines.
• 28 key industry stakeholders wrote a letter to Rep. Schrader and Rep. Kinzinger thanking them for introducing the BIOSIM Act, underscoring the importance of this legislation
• President Biden issued an Executive Order promoting increased biosimilars adoption, among other health-related objectives.

August

• A collection of 16 patient advocacy organizations penned a joint letter to CMS and HHS calling for a zero co-pay policy on biosimilars for Medicare Part B patients.

September

• The 2021 U.S. Generic and Biosimilar Medicines Savings Report released by the Association for Accessible Medicines and the Biosimilars Council found biosimilars continue to contribute substantial savings to patients and providers.
• HHS released its plan to address high drug prices following President Biden’s Executive Order, in part calling for legislation to encourage the use of biosimilars.

October

• The Biosimilars Council marked Breast Cancer Awareness month by sharing encouraging numbers from the savings report regarding oncology spending. The report found biosimilarshelped cut the oncology spending growth rate nearly in half since 2019, and along with generic medicines, generated $16 billion in oncology savings in 2020.

November

• The Biosimilars Council, as a member of the International Generic and Biosimilar Medicines Association, led the engagement with organizations and individuals in the U.S. during the second annual Global Biosimilars Week. This week is devoted to raising awareness around the globe about biosimilars through a social media campaign sharing biosimilars resources and stories under the hashtag #GlobalBiosimilarsWeek.
• AAM and its Biosimilars Council hosted the GRx+Biosims 2021 conference, the premier scientific and regulatory event for the U.S. generics and biosimilars industry. During this three-day event, expert panelists discussed the positive direction of the biosimilars industry.

December

• Members of Congress are currently considering a drug-pricing framework under the Build Back Better bill that would generate short-term savings, but risk even greater savings in the future and impose higher costs on patients with commercial insurance. By instituting price controls, Congress threatens to unintentionally weaken the biosimilars industry, which already provides billions in savings each year. Reach out to your member of Congress and demand he or she oppose this perilous legislation.

Want to hear directly from Executive Director Christine Simmon?

Follow her on Twitter @CSimmon_DC

Interested in joining the Biosimilars Council?

Contact Jewel Smith (jewel.smith@accessiblemeds.org) for more information.