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 percentage points in 30+ countries by 2030, Act4Biosimilars is led by a multidisciplinary stakeholder group of patient advocacy leaders, healthcare professionals, biosimilar experts and industry leaders representing views 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.

The Act4Biosimilars Action Plan provides strategies, tools and activities 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 30 countries have been selected according to their current status of adoption of biosimilar medicines. Furthermore, they were selected to ensure geographically distributed emphasis across the Americas, Europe, Middle East, Africa and Asia:

  • Americas: Brazil, Canada, Chile, Colombia, Ecuador, Mexico, the US
  • Europe: Finland, France, Germany, Hungary, Italy, Latvia, Norway, Czechia, Romania, Spain
  • Middle East & Africa: Egypt, Morocco, Pakistan, Saudi Arabia, South Africa, Türkiye, the UAE
  • Asia: Australia, Indonesia, Japan, New Zealand, Thailand, Vietnam

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 the adoption of biosimilars? How frequently will that be measured? How will those changes be shared?

Tracking Biosimilar Adoption Across 30 Target Countries:

A classification system of high, medium or low favorability will be established by using information from IQVIA to answer a series of questions (listed below). This will be repeated every two years to measure the progress of biosimilar adoption in each country. 

  1. Does a regulatory pathway exist for biosimilars? If “yes,” does it differentiate between biosimilars and biocopies? 
  2. Does the regulatory pathway for biosimilars allow indication extrapolation?
  3. On average and over the previous five years, how long has it taken for a biosimilar to be registered?
  4. In total, how many biosimilar products have received regulatory approval? If there are two or more biosimilar products for the same molecule (i.e., INN), please consider each brand as an individual product.
  5. Are there existing government and payer policies and/or incentives (e.g., pricing, reimbursement) that encourage transitioning patients to biosimilars? If “yes,” has there been a consistent year-on-year increase in overall biosimilar uptake by volume? 
  6. Other than policies related to transitioning, are there other laws or regulations that encourage biosimilar uptake?
  7. Do health-related government bodies (e.g., regulatory agencies and health ministries) make available educational materials on biosimilars to local stakeholders (e.g., healthcare professionals and patients)?
  8. Have there been instances where you have seen a delay by years of the availability of biosimilars referencing certain molecules? What were perceived as the main reasons for such delay(s)? 
  9. Do local biosimilar and/or generics industry trade associations publish and make available biosimilar educational materials?
  10. Do local registries, health authorities or healthcare professionals collect and publicize real-world data (e.g.., pharmacovigilance) on biosimilars? 
  11. Are there any government regulations or public/private incentives that encourage pharmacists, physicians and/or nurses to educate both naive and existing patients transitioning to biosimilars?
  12. Do local pricing regulations allow for biosimilars to compete on price? 
  13. On average, how much market share do biosimilars constitute relative to their respective reference products? 
  14. Are there any local industry associations entirely or partially dedicated to advancing biosimilars?  

Achieving the Mission: increasing global biosimilar adoption by at least 30 percentage points:

When Act4Biosimilars launched in 2022, combined biosimilar adoption across the 30 target countries in scope of tracking was 14%* compared to the reference molecules, despite nearly 20 years of biosimilar availability. This re-affirms there are still many patients who are still unable to access biologic medicines due to inequalities and inequities. It is time to act to drive change.  

The Act4Biosimilars Mission aims to increase current biosimilar adoption by at least 30 percentage points, resulting in a minimum target of 44% biosimilar adoption by 2030. To enact global change, it is important to set ambitious targets – every percentage point gained could mean thousands more lives are changed through greater access to medicines. The number of biosimilars available to patients is rising and year-on-year growth is expected to increase, but this is not consistent, and adoption remains uneven across the globe. This is why setting a biosimilar adoption target of at least 44% across 30 target countries is a bold mission

Achieving the Mission will take dedicated action from people like you, those who are passionate about increasing patient access to life-changing, advanced medicines. It will also need a step change from multiple stakeholders globally such as payers, regulatory agencies, healthcare professionals and the patient community. By combining our efforts, we can make change happen and benefit patients worldwide.

The data used is from IQVIA MIDAS (full year 2022). To ensure that this global metric is relevant until 2030, it includes all reference biologics where the patent will expire over the course of the initiative. Using all reference biologics ensures that the global metric is as representative of the global situation as possible. 

The country-level and global metrics will be updated every two years to allow time for the changes implemented to have an impact and be reflected in the data collected. The updated data will be presented on the “Act4Biosimilars Impact Index”, which monitors the countries’ progress to increase the global adoption of biosimilars by at least 30 percentage points in 30+ countries by 2030.

* Data on file. (IQVIA MIDAS 2022)  



A biological medicine (commonly referred to as a “biologic” or “biopharmaceutical”) is a pharmaceutical whose active substance is made by or extracted from living organisms, tissues, or cells. Any biologic will display a certain degree of variability (“microheterogeneity”), even within and between different batches of the same medicine.


A biosimilar is a biologic medicine that is a successor to an existing biologic (reference medicine) for which the patent has expired. To be approved for use, a biosimilar has to match the reference medicine in terms of safety and efficacy. This is based on advanced laboratory studies and clinical trials in patients. 

Reference medicine

A reference medicine is used as the comparator in head-to-head comparability studies with the proposed biosimilar. Only a medicine that was licensed on the basis of a full registration dossier can serve as a reference medicine.

Non-comparable biologic

A copy of a reference biologic that does not meet the strict regulatory requirements for biosimilar approval (such as those set up by the EMA, WHO, or US FDA) but is being marketed in some countries. Also called “biomimic”, “bioquestionable”, “biocopy”, “intended copy”, or “non-regulated copy”.


  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 (