Safe Biologics

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.

Alliance for Safe Biologic Medicines Launches Webinar Series

Starting in November, The Alliance for Safe Biologic Medicines will host several webinars on biologic and biosimilar medicines, hosted by Alliance Chairman Dr. Richard Dolinar. Registration is free!

Biologics 101: What are biologics and why should you care?
Thursday, November 17, 2:30 PM EST

Click here to Register!

• Role of biotechnology in medical advancements
• What are biologics
• Examples of biologic medicines
• Manufacturing process
• Chemical drugs vs. biologic medicines
• Implications of size, variability, complexity
• What’s next for biotechnology

Biosimilars 101: What are biosimilars and why should you care?
Thursday, December 1, 2:30 PM EST

Click here to register!

• What are biosimilars
• Why are biosimilars not generics
• Manufacturing
• The FDA’s “biosimilar pathway”
• Policy Considerations

Pharmacovigilance 101: What is it and why is it important?
Thursday, December 15, 2:30 PM EST

Click here to register!

• What is pharmacovigilance
• Track & Trace systems for biologic medicines
• Coding, Naming, Labeling
• Down the Road: Interchangeability and Drug Substitution

Alliance for Safe Biologic Medicines Launches Webinar Series

Starting in November, The Alliance for Safe Biologic Medicines will host several webinars on biologic and biosimilar medicines, hosted by Alliance Chairman Dr. Richard Dolinar. Registration is free!

Biologics 101: What are biologics and why should you care?
Thursday, November 17, 2:30 PM EST

Click here to Register!

• Role of biotechnology in medical advancements
• What are biologics
• Examples of biologic medicines
• Manufacturing process
• Chemical drugs vs. biologic medicines
• Implications of size, variability, complexity
• What’s next for biotechnology

Biosimilars 101: What are biosimilars and why should you care?
Thursday, December 1, 2:30 PM EST

Click here to register!

• What are biosimilars
• Why are biosimilars not generics
• Manufacturing
• The FDA’s “biosimilar pathway”
• Policy Considerations

Pharmacovigilance 101: What is it and why is it important?
Thursday, December 15, 2:30 PM EST

Click here to register!

• What is pharmacovigilance
• Track & Trace systems for biologic medicines
• Coding, Naming, Labeling
• Down the Road: Interchangeability and Drug Substitution