• 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

FDA Chaos Threatens Administration’s Drug Agenda and Risks Patient Safety

Washington Examiner (Opinion): FDA Chaos Threatens Administration’s Drug Agenda and Risks Patient Safety March 15, 2026 | Dr. Cristina Beato  The Trump Administration recently celebrated one year of embracing the movement to Make America Healthy Again. Unfortunately, many of these successes are overshadowed by slapdash decision-making at a key health agency, which significantly undermines the Administration’s goals, threatens treatment […]

Read More

ASBM Statement Commending Senator Jim Banks for Introducing the SAFE Drugs Act of 2025

Download PDF version here February 16, 2026 The Alliance for Safe Biologic Medicines (ASBM) commends Senator Jim Banks (R-IN) for introducing the Safeguarding Americans from Fraudulent and Experimental Drugs (SAFE Drugs) Act of 2026 in the United States Senate. We also support the bipartisan companion bill (H.R. 6509), introduced in the House of Representatives by […]

Read More

ASBM Statement on FDA Commissioner’s Comments Regarding Compounded Medicines

February 6, 2026 The Alliance for Safe Biologic Medicines (ASBM) welcomes FDA Commissioner Marty Makary’s comments on the social media platform X affirming that “the FDA cannot verify the quality, safety, or effectiveness of non-approved drugs” and warning that the agency will “take swift action against companies mass-marketing illegal copycat drugs.” These remarks accurately reflect […]

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