Alliance for Safe Biologic Medicines

What Alliance for Safe Biologic Medicines does

Alliance for Safe Biologic Medicines (ASBM) is a nonprofit policy advocacy organization founded in 2010 and headquartered in Arlington, Virginia. Its mission is to promote the safe use of biologic medicines, including biosimilars, by engaging with patients, healthcare providers, and policymakers on regulatory science and legislative policy. ASBM operates a Steering Committee composed of patient organizations, medical societies, pharmacist associations, and research entities, and it participates in regulatory consultations with the FDA, EMA, WHO, Health Canada, and Australia's TGA.

ASBM's core deliverables are advocacy outputs: continuing education courses, policy white papers, international conferences, webinars, and direct engagement with U.S. federal and state legislatures. It has run educational and advocacy programs on legislation including the Inflation Reduction Act, the MINI Act, and the SAFE Drugs Act, and has partnered with academic institutions such as The Ohio State University College of Pharmacy to deliver continuing education for pharmacists. The organization publishes email newsletters and convenes stakeholders to discuss compounding policy, biosimilar interchangeability, and naming conventions.

Revenue is generated through member partner dues from its Steering Committee coalition, with no commercial product or fee-for-service revenue. ASBM does not develop proprietary technology or operate a software platform; its value proposition is institutional credibility, coalition management, and policy expertise rather than a productized offering. Operational scope is modest, with 11-50 employees, and the organization's influence is disproportionate to its size due to its multi-stakeholder governance model.

Name

Alliance for Safe Biologic Medicines

Legal name

Alliance for Safe Biologic Medicines

Website

https://safebiologics.org

Company type

Private

Founded year

2010

Operating status

Operating

Headcount range

11–50 employees

Short description

Alliance for Safe Biologic Medicines is a nonprofit policy advocacy organization that engages regulators and legislators on biosimilars and biologic medicine safety. Founded in 2010 and headquartered in Arlington, VA, it serves patients, healthcare providers, and policymakers through a multi-stakeholder coalition.

Ownership category

akta.pro rank

Product category

Biosimilars Policy Advocacy

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Biologics & Vaccine Regulators (HLAJADAB)

akta.pro secondary industries

Regulatory Affairs, Labeling & Advertising/Promotion Compliance (HLAJADAI), Health, Pharmaceuticals & Medical Devices Regulatory Cooperation (BPADANAJ)

Keywords

• Biosimilar policy advocacy
• Biologic medicines education
• Healthcare policy research
• Regulatory comment letters
• Patient safety advocacy

Headquarters

HQ city

Arlington

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Others

Revenue model

1. Membership dues: The Alliance is funded by its member partners, who contribute dues to support the organization's advocacy and educational activities on biosimilars policy.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels7 records

Core offering

The Alliance for Safe Biologic Medicines (ASBM) is a nonprofit policy advocacy coalition that shapes biosimilars regulatory policy through educational resources, physician surveys, whitepapers, continuing education courses, webinars, and formal comment letters to global regulators. The organization convenes physicians, pharmacists, patient advocates, researchers, and biopharmaceutical manufacturers to advocate for patient safety, science-based regulatory standards, and physician decision-making authority over biologic substitution.

Product overview

The Alliance for Safe Biologic Medicines (ASBM) is a diverse coalition of healthcare stakeholders—not a technology product company—focused on patient safety advocacy and biosimilar medicines policy. ASBM's activities center on educational resources including surveys, webinars, continuing education courses, whitepapers, fact sheets, and dedicated microsites (IRAPatientInfo.org, SafeRxCompounding.org, NoForcedSwitching.ca) that inform healthcare professionals, policymakers, and patients about biosimilar substitution, interchangeability, naming conventions, pharmacovigilance, and related regulatory policies.

Differentiator

Problem solved

Functional benefit

Products and services

• ASBM Physician Survey Program

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

15 partnerships are on record, tiered core and minor.

• Global Colon Cancer Association (GCCA)coreStrategic or Co-development PartnerASBM partners with GCCA on joint webinars and policy initiatives, including a December 2025 webinar on 340B Drug Discount Program reform. GCCA is a member of the ASBM Steering Committee.
• International Cancer Advocacy Network (ICAN)coreStrategic or Co-development PartnerICAN is a Steering Committee member; ASBM has joined ICAN-led coalitions on issues including march-in rights opposition.
• American Academy of DermatologycoreStrategic or Co-development PartnerSteering Committee member representing dermatology specialty perspective on biologic and biosimilar policy.
• Alliance for Patient AccesscoreStrategic or Co-development PartnerSteering Committee member focused on patient access and physician-patient relationship protection.
• American Autoimmune Related Diseases Association (AARDA)coreStrategic or Co-development PartnerSteering Committee member representing autoimmune disease patient perspectives.
• Global Healthy Living FoundationcoreStrategic or Co-development PartnerSteering Committee member representing chronic disease patient advocacy.
• National Psoriasis FoundationcoreStrategic or Co-development PartnerSteering Committee member representing psoriasis patients who are users of biologic medicines.
• Coalition of State Rheumatology OrganizationscoreStrategic or Co-development PartnerSteering Committee member; ASBM presents CE modules on PBM practices developed with CSRO leadership.
• Ohio State University College of PharmacycoreStrategic or Co-development PartnerASBM partnered with OSU College of Pharmacy to develop a 7-part continuing education course on biosimilars policy, recorded in 2022-2023.
• Biosimilars Working Group (Canada)minorStrategic or Co-development PartnerASBM is a member of the Canadian Biosimilars Working Group coalition focused on patient-centered health policy in Canada.
• U.S. Food and Drug Administration (FDA)coreStrategic or Co-development PartnerASBM engages in formal consultations with FDA, submits comment letters on draft guidance documents, and participates in public hearings on biosimilar policy implementation.
• European Medicines Agency (EMA)coreStrategic or Co-development PartnerASBM submits comments to EMA consultations on biosimilar development policies and has commented on the Reflection Paper on tailored clinical approach in biosimilar development.
• World Health Organization (WHO)coreStrategic or Co-development PartnerASBM has presented at multiple WHO INN (International Nonproprietary Naming) stakeholder sessions and advocated for the Biological Qualifier proposal.
• Health CanadacoreStrategic or Co-development PartnerASBM has presented to and engaged with Health Canada on biosimilar naming and substitution policy issues.
• Australian Therapeutic Goods Administration (TGA)coreStrategic or Co-development PartnerASBM submitted comments to TGA consultation on biosimilar naming and advocated against pharmacist-level substitution of non-interchangeable biosimilars.

Scale indicators2 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Pharmaceutical Research and Manufacturers of America (PhRMA): PhRMA is the largest US pharmaceutical industry trade association, representing innovator biopharmaceutical companies on policy, regulatory, and legislative matters. ASBM shares the same advocacy mission on biologic and biosimilar policy, but operates as a smaller, more specialized coalition with patient and physician representation.
• International Federation of Pharmaceutical Manufacturers and Associations (IFPMA): IFPMA represents the global research-based pharmaceutical industry, including biologic and biosimilar manufacturers, at WHO and international regulatory forums. ASBM presents at WHO INN stakeholder sessions and engages IFPMA-relevant policy debates on biologic naming and access.
• Biotechnology Innovation Organization (BIO): BIO represents the broader biotechnology industry on policy issues including biosimilar naming, regulatory pathways, and biologic safety. ASBM's advocacy aligns with BIO's positions on interchangeability and substitution; both engage in regulatory comment submissions and legislative advocacy.

Regional players

• Medicines for Europe: Medicines for Europe represents the European generic and biosimilar medicines industry, advocating for biosimilar uptake and streamlined regulatory pathways in Europe. ASBM frequently engages with EMA consultations that Medicines for Europe also weights in on, making it a regional counterpart in the biosimilars policy debate.

Direct peers

• National Organization for Rare Disorders (NORD): NORD is a patient advocacy organization representing the rare disease community, including patients on biologic therapies. Both NORD and ASBM engage in policy advocacy on biologic access, drug pricing, and patient safety, though NORD focuses on rare disease specifically.
• Association for Accessible Medicines (AAM): AAM is the primary US trade association for generic and biosimilar manufacturers, advocating for policies that accelerate biosimilar uptake. ASBM frequently opposes AAM's policy positions on substitution and interchangeability, making it a direct counter-position peer in the same biosimilars policy space.
• National Patient Advocate Foundation: National Patient Advocate Foundation advocates for patient access to affordable care and represents patients with chronic, life-threatening, and debilitating diseases. ASBM shares patient advocacy orientation on biologic access and policy, with overlapping CME/educational missions.
• Alliance for Patient Access: Alliance for Patient Access is a national physician-led advocacy organization that protects patient access to approved therapies and the physician-patient relationship. ASBM shares a Steering Committee member with this organization, and both advocate against non-medical switching and payer utilization management.
• Biosimilars Council (an AAM initiative): The Biosimilars Council operates within AAM specifically to advance biosimilar adoption through education, advocacy, and policy. ASBM frequently opposes initiatives the Biosimilars Council champions, making it a direct policy opponent in the biosimilars regulatory space.

Emerging players

• Generics and Biosimilars Initiative (GaBI): GaBI is an independent organization providing rigorous, scientifically sound information on generic and biosimilar medicines through its GaBI Journal and educational resources. ASBM publishes in GaBI Journal and shares the educational mission for biosimilars, but GaBI takes more neutral scientific framing.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks5 records

Key highlights7 records

Customer concentration

• Xx.com/SAFEbiologics
• YouTubeyoutube.com/user/SafeBiologics
• Facebookfacebook.com/profile.php
• LinkedInlinkedin.com/company/alliance-for-safe-biologic-medicines

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about Alliance for Safe Biologic Medicines