Biosimilars Council
The Biosimilars Council is dedicated to increasing patient access to affordable biosimilar medicines by creating a positive environment through education, advocacy, and strategic partnerships. It works to promote biosimilar products in the U.S. market, ensuring safety, efficacy, and cost savings for patients and the healthcare system. It actively participates in industry events, advocates for policies that support biosimilar adoption, and collaborates with stakeholders to foster a competitive biosimilars market.
Industries
Nr. of Employees
small (1-50)
Biosimilars Council
Washington, District of Columbia, United States, North America
Products
Biosimilars Toolkit
A curated collection of shareable educational resources (fact sheets, infographics, videos, stakeholder tracks) explaining biosimilars and policy issues.
Biosimilars Handbook
Comprehensive educational guide covering biosimilars’ safety, efficacy, approval process, and stakeholder guidance.
U.S. Generic & Biosimilar Medicines Savings Report
Annual economic report quantifying national savings from generic and biosimilar medicines, produced with third‑party data providers.
Fact sheets, infographics and whitepapers
Short-form downloadable resources addressing common questions, myths, and regulatory topics related to biosimilars.
Biosimilars Bulletin
Periodic industry bulletin and newsletter that summarizes recent policy developments, organizational updates, events and resources relevant to biosimilars.
Biosimilars 101 educational curriculum
Structured educational chapters and curriculum covering the history, scientific principles, benefits, and regulatory context of biosimilars for diverse audiences.
Biosimilars Toolkit
A curated collection of shareable educational resources (fact sheets, infographics, videos, stakeholder tracks) explaining biosimilars and policy issues.
Biosimilars Handbook
Comprehensive educational guide covering biosimilars’ safety, efficacy, approval process, and stakeholder guidance.
U.S. Generic & Biosimilar Medicines Savings Report
Annual economic report quantifying national savings from generic and biosimilar medicines, produced with third‑party data providers.
Fact sheets, infographics and whitepapers
Short-form downloadable resources addressing common questions, myths, and regulatory topics related to biosimilars.
Biosimilars Bulletin
Periodic industry bulletin and newsletter that summarizes recent policy developments, organizational updates, events and resources relevant to biosimilars.
Biosimilars 101 educational curriculum
Structured educational chapters and curriculum covering the history, scientific principles, benefits, and regulatory context of biosimilars for diverse audiences.
Services
Legislative advocacy, agency engagement, Congressional briefings, and coalition building to influence biosimilar policy and reimbursement.
Creation and distribution of toolkits, handbooks, FAQs, videos and curricula explaining biosimilars, interchangeability, and related policy topics.
Commissioning and publication of economic and market reports quantifying biosimilar savings, utilization, and access impacts.
Planning and hosting industry conferences, panels and webinars to convene stakeholders for discussion of market and policy issues.
Preparation and distribution of press releases, blog posts, newsletters and media outreach to publicize positions, research, and events.
Technical drafting and filing of comment letters, technical briefs and docket submissions in response to agency guidance and rulemaking.
Legislative advocacy, agency engagement, Congressional briefings, and coalition building to influence biosimilar policy and reimbursement.
Creation and distribution of toolkits, handbooks, FAQs, videos and curricula explaining biosimilars, interchangeability, and related policy topics.
Commissioning and publication of economic and market reports quantifying biosimilar savings, utilization, and access impacts.
Planning and hosting industry conferences, panels and webinars to convene stakeholders for discussion of market and policy issues.
Preparation and distribution of press releases, blog posts, newsletters and media outreach to publicize positions, research, and events.
Technical drafting and filing of comment letters, technical briefs and docket submissions in response to agency guidance and rulemaking.
Expertise Areas
- Regulatory policy and government affairs for biosimilars
- Regulatory submissions and public comment on agency guidance
- Health economics and outcomes research (HEOR) and market forecasting
- Stakeholder education, curriculum development and outreach
Key Technologies
- Regulatory policy analysis
- Public docket submissions and guidance comments
- Health economics & outcomes modeling (HEOR)
- Market access modeling and forecasting
News & Updates
The article discusses the positive impact of CMS's decision to revise biosimilars reimbursement in Medicare Part B, which aims to increase patient access and lower federal prescription drug spending.
The article announces the addition of three new members to the Biosimilars Council: Accord Healthcare Inc., Fresenius Kabi USA, LLC, and Sagent Pharmaceuticals, Inc.
The article covers the Supreme Court's decision in Sandoz Inc. v. Amgen Inc., which helps speed patient access to biosimilar medicines by preventing brand manufacturers from extending monopoly protections.
The article discusses the U.S. House of Representatives' passage of the FDA Reauthorization Act of 2017, supporting biosimilar market growth and competition.
A patient story highlighting how biosimilars have improved quality of life.
An interview discussing the advantages of biosimilars in healthcare.
The article discusses the positive impact of CMS's decision to revise biosimilars reimbursement in Medicare Part B, which aims to increase patient access and lower federal prescription drug spending.
The article announces the addition of three new members to the Biosimilars Council: Accord Healthcare Inc., Fresenius Kabi USA, LLC, and Sagent Pharmaceuticals, Inc.
The article covers the Supreme Court's decision in Sandoz Inc. v. Amgen Inc., which helps speed patient access to biosimilar medicines by preventing brand manufacturers from extending monopoly protections.
The article discusses the U.S. House of Representatives' passage of the FDA Reauthorization Act of 2017, supporting biosimilar market growth and competition.
A patient story highlighting how biosimilars have improved quality of life.
An interview discussing the advantages of biosimilars in healthcare.