Act4Biosimilars Action Plan Seeks to Increase Patient Access to Biosimilars Globally


The Act4Biosimilars Action Plan highlights major challengers in preventing access to biosimilars and actionable steps to accelerate the adoption by overcoming these challenges.

Sandoz recently announced the launch of the Act4Biosimilars Action Plan, a global roadmap intended to increase patient access to biosimilars. The action plan is part of the Act4Biosimilars initiative founded by the company and launched in 2022, including a goal to increase global biosimilar adoption by at least 30 percentage points in more than 30 countries by 2030.

Credit: Cagkan -

Credit: Cagkan -

“The time to globalize biosimilars is now, so that advanced biologic medicines are accessible to patients who need them most. Their benefits are proven, and it’s time to bring them to more patients and health systems across the world,” Tore K. Kvien, MD, PhD, the previous head of department of Rheumatology in the Diakonhjemmet hospital and member of the Act4Biosimilars Steering Committee, said in a statement.

Even though biosimilars have been available for nearly 20 years, the worldwide adoption rate was only 14% in initiative-tracked countries, whereas the reference drugs are still representing approximately 86% of biologic treatment, according to Sandoz.

The Act4Biosimilars Action Plan highlights major challengers in preventing access to biosimilars, as well as actionable steps to accelerate the adoption by overcoming these challenges.

The Action Plan will include a series of reports identifying key challenges by region, with the first region being the Americas. Key challenges in this region include confusions among patients and health care professionals around interchangeability regulatory guidelines in the United States.

In Colombia and Ecuador, gaps in the regulatory pathways have led to patients being exposed to biocopies, which may not meet the rigorous international guidelines provided by the WHO for the approval of biosimilars. Additionally, in Canada, the United States, and Brazil, the lack of alignment of educational materials across stakeholder groups has led to confusion of health care professionals and patients.

Furthermore, unstainable procurement practices, including single-winner tenders, in Mexico and Brazil, are another common barrier and create supply continuity risks and potential disruptions to patient care.

The Action Plan introduced 12 key initiatives that aim to accelerate biosimilar adoption across the 4As: approvability, acceptability, accessibility, and affordability. The steps are designed to help local stakeholders create a more favorable environment for biosimilars and drive the global adoption, according to the statement.

“Biosimilars can be life-changing for patients and their families and can play a critical role in overcoming health inequalities seen across the world. As a stakeholder-driven initiative, Act4Biosimilars aims to empower local stakeholders on the ground, who are passionate about increasing patient access to advanced medicines,” Laura Wingate, executive vice president of Education, Support, & Advocacy at the Crohn’s &Colitis Foundation, said in the statement.

The committee is working with stakeholders across the Americas to implement the plan and address other key obstacles of biosimilar adoptions. The committee plans to focus on Europe in Q4 2023, the Middle East and Africa in Q1 2024, and Asia Pacific in Q2 2024.

Sandoz estimates that between 2023 and 2027, biosimilars could generate approximately $290 billion in savings globally, though they are currently still unavailable in most countries.


Sandoz introduces Act4Biosimilars Action Plan to accelerate patient access to biosimilar medicines. News release. Novartis. June 15, 2023. Accessed June 16, 2023.

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