Safe Biologics

By Dr. Marcy Zwelling-Aamot, chairperson of the Board of the American Academy of Private Physicians (AAPP)
The Hill 

The U.S. Food and Drug Administration (FDA) is holding an important public meeting today on its proposed biosimilar user fee program recommendations.  This meeting is a major step in making biosimilars available for the first time in the United States.  Biosimilars will benefit the patient community-at-large – but only if important safety measures are adopted.

Biosimilars are the lower cost imitative versions of biological medicines, which are advanced therapies made in living systems.  These cutting-edge medicines treat non-Hodgkin’s lymphoma and several other cancers, Hepatitis C, and even Multiple Sclerosis.  Over 350 million patients worldwide have benefited from approved biologic medicines, and over 650 new biologic medicines and vaccines are being developed to treat more than 100 diseases, yet there are no “biosimilar” versions of these products available in the United States.

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Emerging patient safety issues under health care reform: follow-on biologics and immunogenicity
By Bryan A. Liang and Timothy Mackey
Therapeutics and Clinical Risk Managment

Abstract: US health care reform includes an abbreviated pathway for follow-on biologics, also known as biosimilars, in an effort to speed up access to these complex therapeutics. However, a key patient safety challenge emerges from such an abbreviated pathway: immunogenicity reactions. Yet immunogenicity is notoriously difficult to predict, and even cooperative approaches in licensing between companies have resulted in patient safety concerns, injury, and death. Because approval pathways for follow-on forms do not involve cooperative disclosure of methods and manufacturing processes by innovator companies and follow-on manufacturers, the potential for expanded immunogenicity must be taken into account from a risk management and patient safety perspective. The US Institute of Safe Medication Practices (ISMP) has principles of medication safety that have been applied in the past to high-risk drugs. We propose adapting ISMP principles to follow-on biologic forms and creating systems approaches to warn, rapidly identify, and alert providers regarding this emerging patient safety risk. This type of system can be built upon and provide lessons learned as these new drug forms are developed and marketed more broadly.

Read and download the full study here.

Emerging patient safety issues under health care reform: follow-on biologics and immunogenicity
By Bryan A. Liang and Timothy Mackey
Therapeutics and Clinical Risk Managment

Abstract: US health care reform includes an abbreviated pathway for follow-on biologics, also known as biosimilars, in an effort to speed up access to these complex therapeutics. However, a key patient safety challenge emerges from such an abbreviated pathway: immunogenicity reactions. Yet immunogenicity is notoriously difficult to predict, and even cooperative approaches in licensing between companies have resulted in patient safety concerns, injury, and death. Because approval pathways for follow-on forms do not involve cooperative disclosure of methods and manufacturing processes by innovator companies and follow-on manufacturers, the potential for expanded immunogenicity must be taken into account from a risk management and patient safety perspective. The US Institute of Safe Medication Practices (ISMP) has principles of medication safety that have been applied in the past to high-risk drugs. We propose adapting ISMP principles to follow-on biologic forms and creating systems approaches to warn, rapidly identify, and alert providers regarding this emerging patient safety risk. This type of system can be built upon and provide lessons learned as these new drug forms are developed and marketed more broadly.

Read and download the full study here.