Biosimilars Council

What Biosimilars Council does

The Biosimilars Council is a U.S. trade association and advocacy organization, established in 2015 as a division of the Association for Accessible Medicines (AAM), headquartered at 601 New Jersey Avenue NW, Suite 850, Washington, D.C. It advocates for policies that expand patient access to lower-cost biosimilar medicines through engagement with Congress, the FDA (including the Office of Therapeutic Biologics and Biosimilars), CMS, and state governments. The Council represents biosimilar manufacturers including Alvotech, Amneal Biosciences, Biocon Biologics, Fresenius Kabi, Lupin Pharmaceuticals, Polsinelli, Sandoz Inc., and Teva Pharmaceutical, and leverages AAM's parent infrastructure to represent 90% of prescriptions filled in the U.S. generics and biosimilars space.

Its core offerings consist of policy advocacy services, a resource center of reports, white papers, and educational materials, the annual GRx+Biosims industry conference, and the Biosimilars Patient Resource Center. Key advocacy focus areas include streamlining biosimilar development, reforming the interchangeability designation, combating patent abuse by brand manufacturers, Medicare Part B reimbursement reform, and countering misinformation about biosimilar safety and efficacy. Notable regulatory outcomes include FDA guidance in October 2025 removing comparative efficacy study requirements for biosimilar filings, and the June 2026 passage of the Biosimilar Red Tape Elimination Act and Medication Affordability and Patent Integrity Act through the Senate HELP Committee.

The Council's business model is a membership-funded trade association, with Alex Keeton serving as Executive Director leading the policy team at AAM, and Giuseppe Randazzo serving as Interim Executive Director per the 2025 Savings Report. Operating geographies are exclusively the United States, with select international coordination through the International Generic and Biosimilar Medicines Association (IGBA). The organization is privately held as a division of AAM with 11-50 employees, no public listing, and no external investors.

Name

Biosimilars Council

Legal name

Biosimilars Council

Website

https://biosimilarscouncil.org

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

11–50 employees

Short description

The Biosimilars Council is a U.S. trade association and division of the Association for Accessible Medicines that advocates for policy reform to expand patient access to lower-cost biosimilar medicines, serving biosimilar manufacturers, payers, providers, and policymakers.

Ownership category

akta.pro rank

Product category

Pharmaceutical Industry Advocacy

NAICS

Business Associations (81391), Business Associations (813910)

SIC

Services-Membership Organizations (8600)

akta.pro primary industry

Biosimilar Commercialization & Market Access (pricing, tendering, interchangeability, distribution) (HLAAAHAL)

akta.pro secondary industry

Health Equity, Access & Social Determinants Programs (BPAIAJAO)

Keywords

• Biosimilar medicines advocacy
• Pharmaceutical policy reform
• Biologic drug access
• Healthcare regulatory affairs
• Prescription drug cost reduction

Headquarters

HQ city

Washington

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Marketing or Sales, Operations, Technology or R&D, Others

Distribution channels2 records

Marketing channels9 records

Core offering

The Biosimilars Council is a trade association that advocates for policies and regulations promoting patient access to affordable biosimilar medicines in the United States. It engages with Congress, the FDA, CMS, and state governments on biosimilar-related legislation and reform, while providing member biosimilar manufacturers with policy representation, industry events, and educational resources. The Council also produces reports, white papers, patient stories, and hosts the annual GRx+Biosims conference to educate healthcare professionals, payers, and patients about biosimilars.

Product overview

The Biosimilars Council is a division of the Association for Accessible Medicines (AAM) that works to increase patient access to lifesaving, affordable biosimilar medicines. Rather than a technology product company, the organization provides advocacy services, educational resources, industry events, and patient information tools. Their core offerings include policy advocacy for biosimilar legislation and regulation reform, a comprehensive resource center with reports and white papers, the annual GRx+Biosims industry conference, and the Biosimilars Patient Resource Center for patient education.

Differentiator

Problem solved

Functional benefit

Products and services

• Biosimilars Council Advocacy Services

Quantifiable outcome

• Biosimilars have saved $56.2 billion for patients and healthcare system since 2015
• +3 more outcomes

Segments5 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

Five partnerships are on record, tiered flagship, core and minor.

• Over Three Dozen Healthcare and Patient Advocacy GroupsflagshipStrategic or Co-development Partner · 22 January 2026Coalition of over 36 organizations including Academy of Managed Care Pharmacy, AHIP, American Society for Health-System Pharmacists, Blue Cross Blue Shield Association, CVS Health, Kaiser Permanente, and others joined together to support the Biosimilar Red Tape Elimination Act legislation to remove the arbitrary distinction between interchangeable biologics and biosimilars.
• Association for Accessible Medicines (AAM)coreOthersThe Biosimilars Council is a division of the Association for Accessible Medicines (AAM). AAM is the organization dedicated to improving access to safe, quality, effective medicine. The Council leverages AAM's resources, relationships, and advocacy infrastructure to promote biosimilar access and policy reform.
• International Generic and Biosimilar Medicines Association (IGBA)coreStrategic or Co-development PartnerInternational partnership for global biosimilar advocacy and policy alignment. IGBA and Biosimilars Council (via AAM) collaborate on global regulatory standards and biosimilar access initiatives.
• The Center for BiosimilarsminorStrategic or Co-development PartnerMedia partnership for Global Biosimilars Week webinar focused on streamlining the global regulatory process to advance access to biosimilars.
• FDA Office of Therapeutic Biologics and Biosimilars (OTBB)coreStrategic or Co-development PartnerOngoing regulatory policy engagement with FDA's OTBB reviewers on BsUFA IV enhancements, streamlining biosimilar development guidance, and interchangeability policy reforms.

Scale indicators11 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Pharmaceutical Research and Manufacturers of America (PhRMA): PhRMA is the principal U.S. trade association representing originator biopharmaceutical manufacturers. It is a direct counterpart to the Biosimilars Council, advocating opposing positions on interchangeability, patent reform, and biosimilar market access — making it the most structurally comparable peer.
• Association for Accessible Medicines (AAM): AAM is the parent organization of the Biosimilars Council and the broader generics and biosimilars trade association. It shares identical leadership, infrastructure, and a substantial portion of the advocacy agenda, making it the closest organizational peer.
• International Generic and Biosimilar Medicines Association (IGBA): IGBA is the global counterpart and explicit partner of the Biosimilars Council, coordinating international biosimilar advocacy, regulatory alignment, and policy harmonization — operating as a direct peer at the global level.

Broad incumbents

• Biotechnology Innovation Organization (BIO): BIO is the largest U.S. trade association representing the biotechnology industry, including many originator biologic manufacturers. While broader in scope, BIO operates similar advocacy infrastructure on FDA policy, patent reform, and market access that intersects directly with the Council's agenda.

Regional players

• Medicines for Europe: Medicines for Europe is the leading European biosimilars and generics trade association. It pursues parallel advocacy on EU biosimilar regulatory frameworks and is structurally identical to the Biosimilars Council, but serves a different geography.

Emerging players

• America's Health Insurance Plans (AHIP): AHIP is the principal U.S. payer trade association and a coalition partner of the Biosimilars Council. It addresses overlapping themes on drug pricing, formulary design, and biosimilar coverage policy from the payer perspective.
• Pharmaceutical Care Management Association (PCMA): PCMA represents PBMs and is a critical stakeholder on biosimilar reimbursement and rebate policy. It is referenced indirectly in the Council's customer pain points and operates in the same policy ecosystem on drug pricing.
• Academy of Managed Care Pharmacy (AMCP): AMCP is a professional organization for managed care pharmacists and a coalition partner supporting the Biosimilar Red Tape Elimination Act. It engages in adjacent biosimilar formulary and coverage policy work.

Others

• National Association of Chain Drug Stores (NACDS): NACDS represents retail pharmacy chains and engages on biosimilar substitution, interchangeability, and patient access policy at federal and state levels — adjacent to the Council's mission but from the dispenser perspective.
• European Medicines Agency (EMA) biosimilars stakeholder groups: Regulatory and stakeholder bodies engaged in EU biosimilar policy development. While not a trade association peer, they operate in the same policy advocacy ecosystem for global biosimilar regulatory alignment.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/BiosimsCouncil
• YouTubeyoutube.com/channel/UCWiXuFmnSM1tofP7uQ8kdrA
• Facebookfacebook.com/BiosimsCouncil
• LinkedInlinkedin.com/company/11056735

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about Biosimilars Council