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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 Urges CO PDAB to Reject Upper Payment Limits Without Patient Protections

On May 15, ASBM submitted comments to the Colorado Prescription Drug Affordability Board urging it not to impose an upper payment limit (UPL) on Cosentyx unless the Board can demonstrate that the policy will directly reduce patient out-of-pocket costs without disrupting access to treatment. ASBM emphasized that a UPL would reduce the amount paid by […]

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ASBM Submits Comments to FDA on Biosimilar Draft Guidance

On May 11th, ASBM submitted comments on the FDA’s recently released draft guidance and Q&As aimed at “streamlining” biosimilar development by permitting the use of data from non-U.S.-licensed comparator products and foreign clinical studies in the U.S. biosimilar approval process. While efficiency is important, ASBM is concerned that these changes may lower evidentiary standards in […]

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Take Action: Support the MINI Act to Protect Patient Access to Genetic Therapies

Congress is considering the Maintaining Investments in New Innovation Act (MINI Act) [HR 1672], legislation to protect patient access to genetically targeted therapies (GTTs)—innovative treatments designed to address the underlying genetic causes of serious diseases. Under current law, some of these therapies may face Medicare price controls earlier than similarly complex treatments, simply due to […]

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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