• Who We Are
    • About Us
    • Leadership
    • Member Partners
    • International Advisory Board
  • News
    • Latest News
    • Letters
    • Newsletters
    • Press Releases
    • Recent Events
  • The Issue
    • About the Issue
    • FAQs
    • Naming
    • Substitution Policy
    • Biologic Safety
    • BIO Principles
    • Non-Medical Switching
  • Policy
    • Australia
    • Canada
    • European Union
    • FDA
    • FDA Guidance
    • In the States
  • Resources
    • Surveys
    • Courses
    • Webinars
    • Approvals
  • Blog
  • Videos

Safe Biologics

  • Safe Biologics

  • Who We Are
    • About Us
    • Leadership
    • Member Partners
    • International Advisory Board
  • News
    • Latest News
    • Letters
    • Newsletters
    • Press Releases
    • Recent Events
  • The Issue
    • About the Issue
    • FAQs
    • Naming
    • Substitution Policy
    • Biologic Safety
    • BIO Principles
    • Non-Medical Switching
  • Policy
    • Australia
    • Canada
    • European Union
    • FDA
    • FDA Guidance
    • In the States
  • Resources
    • Surveys
    • Courses
    • Webinars
    • Approvals
  • Blog
  • Videos
shutterstock_235879675

Approvals

Biosimilars approved in Australia

Biosimilars approved in Europe

Biosimilars approved in Latin America

Biosimilars approved in the United States

 

 

 

 

 

Latest News

ASBM to Chair Multiple Panels at Festival of Biologics USA 2021

From March 29-April 1st, ASBM will be participating in the Festival of Biologics USA, part of the World Biosimilar Congress USA 2021. The event is typically held in San Diego, CA but will be held virtually this year due to travel restrictions related to the COVID-19 pandemic.   At the event, ASBM Steering Committee Member Andrew Spiegel […]

Read More

ASBM’s Andrew Spiegel Interviewed on Susan G. Komen Podcast

On January 28, the Susan G. Komen Foundation released an episode of their podcast “Real Pink” entitled  “The Evolution of Biosimilars as a Cancer Treatment” featuring Andrew Spiegel. Mr. Spiegel is Executive Director of the Global Colon Cancer Association and a founding member of ASBM.  In the podcast, Spiegel explains how biologic medicines have extended the life expectancy […]

Read More

ASBM Submits Comments on FDA Draft Guidance on Biosimilarity and Interchangeability

On January 19th, ASBM submitted comments on Draft Guidance issued November 19, 2020 by the FDA entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act” The document offers insights into how FDA will handle certain aspects of submissions and labeling for interchangeable biosimilars. These include how an applicant may seek FDA review for […]

Read More

logo logo logo
logo

The Alliance for Safe Biologic Medicines is an organization composed of diverse healthcare groups — from patients to physicians, medical innovators, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.

Contact Us

Who we are
  • About Us
  • Leadership
  • Member Partners
  • International Advisory Board
News
  • Latest News
  • Letters
  • Newsletter
  • Press Releases
  • Recent Events
The Issue
  • About the Issue
  • FAQs
  • Naming
  • Substitution Policy
  • Biologic Safety
  • BIO Principles
Policy
  • Australia
  • Canada
  • European Union
  • FDA
  • FDA Guidance
  • In the States
Resources
  • Surveys
  • Courses
  • Webinars