Biosimilars Bulletin | November 2020

News and Updates

GRx+Biosims 2020 Conference

We’ve completed this year’s GRx+Biosims conference and are excited to share insights from the top officials and subject-matter experts who spoke at our first-ever virtual event. Speakers addressed the role of generics and biosimilars in increasing patient access to medicines during a global pandemic; generic and biosimilars development; the regulatory process; and the evolving policy landscape.

Biosimilars Council Joins IGBA in Celebrating Global Biosimilars Week

The International Generic and Biosimilar Medicines Association (IGBA) has launched the first Global Biosimilars Week to raise awareness of the value of biosimilars and provide resources for interested persons to find out more about these lower-cost medicines.

Affordable Care Act and the Future of Biosimilars

The U.S. Supreme Court has now heard arguments on the constitutionality of the Affordable Care Act (ACA) which will affect the biosimilars pathway through the Biologics Price Competition and Innovation Act (BPCIA). AAM and its Biosimilars Council will continue to monitor this case and is developing strategies to address any of the several potential outcomes.

B10similars: Reflecting on 10 Years of Biosimilars

Since the Biologics Price Competition and Innovation Act was enacted in 2010 as part of the Affordable Care Act, 28 biosimilars have been approved, providing patients with lower-cost, life-changing medicines.

Why Severability Should Be Every Biosimilar Makers’ Rallying Cry In 2021

Anna Rose Welch writes: “At the AAM GRx + Biosims Virtual Summit, I attended the panel entitled, ‘If the BPCIA Should Fall — SCOTUS Decision Scenario Outlook,’ featuring Chad Landmon, partner, Axinn, Veltrop, & Harkrider. Landmon provided a great overview of the case at hand and laid out how several potential outcomes could impact the BPCIA.”

OTBB Director Discusses FDA’s Roadmap for Biosimilars

Highlighting challenges and ongoing efforts, Sarah Yim, M.D., director of the Office of Therapeutic Biologics and Biosimilars (OTBB) delivered a progress report on the FDA’s Biosimilars Action Plan (BAP) at the AAM GRx+Biosims annual conference.

3 Reasons U.S. Payers Will Make 2021 a Banner Year for Biosimilars

Following a year that saw a 143% increase in launched biosimilars in the U.S., here are three reasons why payers will drive adoption further in 2021.

Regulatory Policy May Not Stop Comparative Efficacy Trials

Regulatory authorities in the United States and Europe may not require clinical efficacy studies if they feel satisfied that other evidence presented by biosimilar developers is adequate to make the case for approval.

Managing Biosimilar Product Selection: Practical Considerations for Implementation of Biosimilars in Oncology

Although the introduction of additional biosimilars in oncology comes with the hope of significant health care savings, individual institutions are faced with growing challenges related to formulary management.

Insulin Biosimilars Market

Biosimilars are almost identical to their original products and are available at affordable prices. This aspect makes insulin biosimilars a preferred choice for many. In addition, numerous insulin-producing companies are set to lose their patent soon, which further increases the growth rate of the insulin biosimilars market.

Featured Resources

Lessons for the United States on Europe’s Biosimilar Experience

The United States established its biosimilars pathway ten years ago. This new white paper by Alex Brill, founder of Matrix Global Advisors, discusses what the United States can learn from Europe’s longer — but not necessarily more successful — experience with biosimilars.

Biosimilars Approvals and Launches

The Biosimilars Council compiled a comprehensive resource on the latest FDA-approved biosimilars, including launch dates where applicable.

2020 Generic Drug & Biosimilars Access & Savings in the U.S. Report

This year’s Generic Drug Access & Savings in the U.S. report released by AAM shares insight into the impact of biosimilars and generics to date and provides a critical look at how brands’ anti-competitive practices can negatively affect patients.

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 www.accessiblemeds.org.