Biosimilars Bulletin | March 2020

News and Updates

Our COVID-19 response is focused on ensuring patients have access to their biosimilar medicines. During this challenging time, we have consolidated recommendations from government experts and responses to frequently asked questions about biosimilar medicines and housed them on a page at the page below. We will continue to keep these materials updated and share any new information on the Biosimilars Council social media channels.

COVID-19: FAQs

Now more than ever, we appreciate your support and continued engagement. You can help others by sharing these resources in your social networks while our members continue to work on meeting the health care needs of America’s patients.

Preserving Patient Access to Low-Cost Medicines Through COVID-19 and Beyond

Our steadfast support for all who are battling COVID-19, from the patients diagnosed with the disease to the health care professionals providing their care. For our part, biosimilar manufacturers are committed to serving as a trusted partner and resource to the United States government and all those responding to this pandemic.

Biosimilars Review & Report: A Conversation With Christine M. Simmon

Executive Director Christine Simmon recently sat down with Biosimilars Review & Report’s Stanton Mehr to discuss topics from biosimilar uptake to the Council’s current priorities.

Battle continues over ‘Buy American’ order

In a letter to Trump on Thursday, the groups wrote that proposals to bring all manufacturing back to the U.S. “not only overestimate the potential feasibility and underestimate the time and effort it would take to make such changes, but also misunderstand that a diverse pharmaceutical supply chain is precisely what enables the industry to respond quickly and make adjustments in its supply chain sourcing during natural emergencies and global public health crises.”

Enforcers, Experts Discuss Tamping Down Anticompetitive Behavior in Bio Market During FDA/FTC Workshop

The FDA/FTC Workshop set in motion the agencies’ joint effort to address the difficulties in biosimilar uptake – a market rife with anticompetitive practices – and to restrict the dissemination of false and misleading information on biosimilar efficacy or safety.

Biosimilars Council Applauds FDA’s Release of Enhanced Purple Book

The Council applauds the FDA’s action and continues to call on policymakers to support legislation that would require all patents for the reference biologic to be listed in the Purple Book.

Biosimilars In The Pandemic Age: Current Impact And Market Implications

Though a pandemic can be devastating from an economic and public health standpoint, the industry has energetically (and then some) risen to the task of finding vaccines and supportive treatments.

Biosimilar Pipeline Experiencing 12% Annual Growth: A Progress Update

This article compares aspects of the biosimilar development pipeline and related market evolution over the past seven years, since 2013, including what has and hasn’t changed.

Role of Biosimilars in U.S. vs Europe

This video outlines discussion on the adoption of biosimilars in the U.S. vs Europe and the potential cost savings associated

Biosimilars Study Shows Massive State Savings Potential

According to a study released by Pacific Research Institute, biosimilars have the potential to bring significant savings to both state Medicaid programs and consumers with commercial insurance.

When cost saving is lifesaving: Expanding patient access to biosimilars

Retired Senator Orrin Hatch – a policy leader ensuring competition in the pharmaceutical marketplace – discusses how biosimilars offer new promise to patients with a host of debilitating illnesses, including cancer, multiple sclerosis and rheumatoid arthritis, to name a few.

Featured Resources

NEW RESOURCE: Increase Patient Access to Lower-Cost Biosimilar Medicines

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

Member Spotlight Series

As part of the Biosimilar Council’s commitment to broad stakeholder education about the promise of biosimilars, we’ve launched the first in a series of member spotlights. We are thrilled to begin with Dr. Hillel Cohen, Executive Director, Scientific Affairs at Sandoz, Inc.

Failure to Launch White Paper Series

The Biosimilars Council found that delayed entry of biosimilars dur to brand-name biologic companies’ anti-competitive market access tactics have cost the U.S. health care system billions of dollars in lost savings.

Upcoming Events

GRx+Biosims 2020

Planning + Ready Join us November 9-11, 2020 in North Bethesda, Maryland for GRx+Biosims 2020. GRx+Biosims is the premier scientific and regulatory event for the U.S. generics and biosimilars industries, featuring timely programming relevant to technical, regulatory and policy professionals. Hear from top-in-their-field officials and subject-matter experts; share knowledge and best practices; and gain insights on navigating the regulatory process approvals and the evolving policy landscape.

Register

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.