• Who We Are
    • About Us
    • Contact Us
    • Member Partners
  • News
    • Latest News
    • Letters
    • Newsletters
    • Press Releases
    • Recent Events
  • The Issue
    • Interchangeable Biosimilars
    • Inflation Reduction Act (IRA)
    • Naming
    • Biologic Safety
    • BIO Principles
    • Non-Medical Switching
  • Policy
    • Australia
    • Canada
    • FDA
    • FDA Guidance
    • In the States
  • Resources
    • Surveys
    • Courses
    • Webinars
    • Approvals
    • Whitepapers
  • Blog
  • Videos

Safe Biologics

  • Safe Biologics

  • Who We Are
    • About Us
    • Contact Us
    • Member Partners
  • News
    • Latest News
    • Letters
    • Newsletters
    • Press Releases
    • Recent Events
  • The Issue
    • Interchangeable Biosimilars
    • Inflation Reduction Act (IRA)
    • Naming
    • Biologic Safety
    • BIO Principles
    • Non-Medical Switching
  • Policy
    • Australia
    • Canada
    • FDA
    • FDA Guidance
    • In the States
  • Resources
    • Surveys
    • Courses
    • Webinars
    • Approvals
    • Whitepapers
  • Blog
  • Videos

Whitepapers

A Critical Review of Substitution Policies for Biosimilars in Canada (GaBI Journal, 2021)

US Biosimilar Market on Pace with Europe (GaBI Journal, 2020)

European prescribers’ attitudes and beliefs on biologicals prescribing and automatic substitution  (GaBI Journal, 2020)

Policy recommendations for a sustainable biosimilars market: lessons from Europe (GaBI Journal, 2020)

Medicines regulation in the MENA Region and the importance of the World Health Organization’s INN proposal of Biological Qualifier (GaBI Journal, 2018)

A survey of Australian prescribers’ views on the naming and substitution of biologicals (GaBI Journal, 2017)

Naming and labelling of biologicals – a survey of US physicians’ perspectives (GaBI Journal, 2017)

Clear naming, traceability of biological medicines will protect patients (GaBI Journal, 2017)

Naming and labelling of biologicals – the perspective of hospital and retail pharmacists (GaBI Journal, 2015)

Prescribing practices for biosimilars: questionnaire survey findings from physicians in Argentina, Brazil, Colombia and Mexico (GaBI Journal, 2015)

Biosimilars naming, label transparency and authority of choice – survey findings among European physicians (GaBI Journal, 2014)

The future of biological therapy: a pathway forward for biosimilars (GaBI Journal, 2013)

‘It’s all about the name: what is the imperative of adopting unique names for biologic and biosimilar therapeutics?’ (Food and Drug Law Institute, 2012)

 

Latest News

ASBM Submits Comments Urging FDA to Maintain Stringent Approval Standards, Opposing “Genericization” of Biosimilars

On October 19th, ASBM submitted detailed comments to the U.S. Food and Drug Administration regarding its September 19 public workshop, Advancing the Development of Interchangeable Products: Identifying Future Needs (Docket No. FDA-2025-N-2787). ASBM expressed strong concern over signals that FDA may move toward “genericizing” biosimilars—modeling their approval and substitution on small-molecule generics—calling such a shift “scientifically inappropriate […]

Read More

ASBM Announces Retirement of Doug Badger,Welcomes Beato and Downing to Board

ARLINGTON, VA — July 7, 2025 — The Alliance for Safe Biologic Medicines (ASBM) today announced the retirement of longtime Board member Doug Badger, and the appointment of two new members to its Board of Directors: Cristina V. Beato, MD, and Chris Downing, both of whom previously served in senior leadership roles at the U.S. […]

Read More

MFN: Medicines For No-One

What is MFN?—Why It’s a Threat to Patients The Most Favored Nation (MFN) drug pricing policy ties U.S. medicine prices to those in countries with strict government price controls. This may sound like a win for patients, but MFN imports the very systems that limit access, delay innovation, and lead to higher death rates abroad—especially […]

Read More

logo logo logo
logo

The Alliance for Safe Biologic Medicines (ASBM) is a diverse coalition of stakeholders working worldwide to shape policies that reflect the best interests of patients, ensuring access to lifesaving and life-enhancing medicines while fostering innovation in healthcare.

Contact Us

Who we are
  • About Us
  • Contact Us
  • Member Partners
  • International Advisory Board
News
  • Latest News
  • Letters
  • Newsletter
  • Press Releases
  • Recent Events
The Issue
  • Interchangeable Biosimilars
  • Inflation Reduction Act (IRA)
  • Naming
  • Substitution Policy
  • Biologic Safety
  • BIO Principles
Policy
  • Australia
  • Canada
  • European Union
  • FDA
  • FDA Guidance
  • In the States
Resources
  • Surveys
  • Courses
  • Webinars