Frequently Asked Questions

What is Act4Biosimilars?

Act4Biosimilars is a global initiative aimed at increasing patient access to biologics medicines by facilitating greater approvability, accessibility, acceptability and affordability of biosimilars.

With a mission to increase the global adoption of biosimilars by at least 30% in 30+ countries by 2030, Act4Biosimilars is led by a multidisciplinary stakeholder group of patient advocacy leaders, healthcare professionals, biosimilar experts and industry leaders from around the world.

Act4Biosimilars seeks to bolster the global biosimilar movement by clearly aligning and informing action on biosimilar challenges and opportunities for patient access and sustainable healthcare and is supported by founding sponsor, Sandoz.

What are biosimilars? How are they different from biologic medicines?

A biosimilar is a successor to a biological medicine (also known as “reference medicine”) for which the patent has expired and exclusivity has been lost.1,2

Biosimilars match their respective reference medicine in terms of quality, safety and efficacy. Hence, the biosimilar has been proven to act in the same way as the reference medicine in indications and patient populations that the reference medicines are approved in.

Biosimilars are used in the treatment and prevention of many disabling and life-threatening disease area’s such as oncology, rheumatology, dermatology and endocrinology. 

What is the difference between biosimilars and generics?

Biosimilars are medicines that are a “copy” of a biological medicine, also known as a biologic, which are produced by a complex process involving living organisms. Due to the complex nature of biologics, it requires extensive expertise and considerable investment to develop and make them.

Whereas a generic is an exact copy of a chemical medicine – in comparison to a biologic, most are much simpler to make.

Are biosimilars as safe and effective as their reference medicines?

Yes, biosimilars are both as safe and effective as their reference medicine. Regulatory bodies such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) will only approve a biosimilar if it is demonstrated that the biosimilar matches the reference medicine in terms of quality, safety and efficacy and that there are no clinically meaningful differences. 

In terms of safety, the EMA’s Information Guide for Healthcare Professionals stated that “over the last 10 years, the EU monitoring system for safety concerns has not identified any relevant difference in the nature, severity or frequency of adverse effects between biosimilars and their reference medicines.”3

What is the role of the Act4Biosimilars Steering Committee?

The Steering Committee is dedicated to focusing on actionable steps to support biosimilar adoption globally. The role of the Steering Committee is to:

  1. Provide insight and counsel on the challenges and opportunities to be addressed by the Act4Biosimilars initiative
  2. Create solutions and resources for international and local country use and
  3. Take an active role in communicating the mission, actions and tools to decision-makers, peers and other key stakeholders in their region/countries.

As the founding sponsor, Sandoz convened the Steering Committee based on knowledge and expertise in their field. 

What is different about Act4Biosimilars, compared to other efforts regarding biosimilars?

While there are many ongoing efforts to increase awareness, knowledge and uptake of biosimilars around the world, these efforts are often taking place independently.

Act4Biosimilars brings together countries that are at different stages of biosimilar adoption – some countries are aspiring, whereas others are progressing or advanced – and aims to take a much more inclusive approach to driving global biosimilar adoption.

It is led by a multidisciplinary Steering Committee who are committed to build upon the progress that has been made so far and expand to more countries than before. By co-creating the Action Plan with experts from patient organizations, healthcare professionals, trade associations, think tanks, government bodies and professional societies.

Act4Biosimilars will be creating an Action Plan that provides tangible strategies, tools and guidance to support improving the approvability, accessibility, acceptability and affordability of biosimilars across the 30 countries and beyond.

What other roles do you have as part of Act4Biosimilars? e.g., I am passionate about the mission and want to support, what can I do?

As well as using the tools and resources to drive action locally, there are two key roles in the Act4Biosimilars initiative, we have Advisors and Partners.  

An advisor is an external subject matter expert (who are not members of the Steering Committee), who is approved by the Steering Committee. Advisors will be asked to participate when and, where needed, by the working group. 

Partners could potentially be organizations to which the Committee members belong, and/or other endorsers interested in the Act4Biosimilars initiative. They can be academic institutions, stakeholders involved in access to medicines, as well as media outlets. The role of Partners is to provide their views on the work of the Act4Biosimilars initiative, potential endorsement, offer platforms for communication and presentations. Partners can be suggested by members of the Committee and will go to a vote.

If you are interested in either becoming an Advisor or Partner, then direct contact can be made with Act4Biosimilars via direct message on LinkedIn or Twitter.

The mission refers to 30+ countries. What are these countries and why were they chosen?

The countries have been selected according to their current status of adoption of biosimilar medicines. Furthermore, the 30 countries were selected from across the world, to ensure geographically distributed emphasis across the Americas, Europe, Middle East, Africa and Asia.

The diversity of the selection allows for knowledge and resource sharing for all countries across the world.

Is Act4Biosimilars open to increasing the number of countries within its scope?

We are currently focusing on the 30 countries selected, however we say 30+ as we may look to extend in the future. In the meantime, other countries can leverage the Act4BiosimilarsAction Plan and work towards improving biosimilar adoption by using the strategies, tools and guidance that are relevant to their country.

How will Act4Biosimilars measure changes in adoption of biosimilars? How frequently will that be measured? How will those changes be presented?

The data measuring the success will be visualized on Country Indicator Maps located on the Act4Biosimilars website and will show how the 12 goals are increasing biosimilar adoption.

This gives the user an opportunity to explore how each of the country is progressing with the mission of increasing global adoption of biosimilars by at least 30% in 30+ countries by 2030. The data will be updated every two years.


  1. Weise M, et al. Biosimilars: what clinicians should know. Blood 2012;120:5111-7.
  2. Kay J. A ‘wind of change’ to biosimilars: the NOR-SWITCH trial and its extension. J Intern Med. 2019;285:693-5.
  3. European Medicines Agency and European Commission. Biosimilars in the EU: Information guide for healthcare professionals. 2019. Available from: Biosimilars in the EU - Information guide for healthcare professionals (