The biosimilar landscape

Impact on patient care

Biologics have revolutionised treatment across therapeutic areas:1


  1. Adapted from Gherghescu I and Begoña Delgado-Charro M. The biosimilar landscape: An overview of regulatory approvals by the EMA and FDA. Pharmaceutics 2021;13:48.

For more on information on the impact on patient care, please click on the following video:

Satellite Symposium at ECCO Congress 2020

07/05/2021 | 52:37

For more information on the basics of biosimilars, please see the following publications:

Evolution of the EU Biosimilar Framework: Past and Future.

BioDrugs. 2019;33(6):621-634.

The authors of this review focused on the nature and extent of clinical confirmation, in addition to analytical and functional data required by the European Medical Agency (EMA) for the approval of biosimilar products.

need texts

Unmet need and limited access

Immune-Mediated Inflammatory Disorders (IMID) are progressive diseases, requiring timely and continuous treatment. Current guidelines often reserve these treatments for patients with more severe disease and/or patients who have failed to respond to multiple other treatments.1 In some countries, access to biologics may then be further limited by the implementation of national eligibility and reimbursement criteria,1 creating an unmet need in many countries worldwide.


  1. Edwards CJ, Hercogová J, et al. Switching to biosimilars: current perspectives in immune-mediated inflammatory diseases. Expert Opinion on Biological Therapy 2019; 19(10):1001-1014

Patient access to biologics is variable..

Adapted from Baumgart DC, Misery L, et al. Front Pharmacol 2019;10:279

.. as access is linked to affordability:

Associations between affordability and the uptake of biosimilars in Crohn’s disease 

Cz=Czech Republic; D=Germany; Es=Spain; Fr=France; Hu=Hungary; Lv=Latvia; Pl=Poland; Ro=Romania; Se=Sweden; Sk=Slovakia

Adapted from Pentek M, Lakatos PL, et al, World J Gastroenterol 2017;23:6294–6305

Increasing number of biosimilars

Biosimilars are mainly approved in 3 key fields:1

  • Oncology
  • Immunology
  • Infection/anemia 

..though the potential use of  biosimilars in other emerging treatment areas is growing – e.g. ophthalmology,2  diabetes,3 controlled ovarian stimulation for IVF,4 and hematopoietic cell transplantation.5


  1. Ebbers H and Schellekens H. Drug Discov Today 2019;10:1963–1967
  2. Sharma A, Reddy P, et al. Biosimilars in ophthalmology: “Is there a big change on the horizon?" Clin Ophthalmol 2018; 12: 2137–2143
  3. Peters AL, Pollom RD, et al. Biosimilars and new insulin versions. Endocrine Practice 2015;21(12):1387-94
  4. Bergandi L, Canosa S, et al. Human recombinant FSH and its biosimilars: Clinical efficacy, safety, and cost-effectiveness in controlled ovarian stimulation for in vitro fertilization. Pharmaceuticals (Basel) 2020;13(7):136 
  5. Korkmaz S and Altunas F. What is the role of biosimilar G-CSF agents in hematopoietic stem cell mobilization at present? Transfus Apher Sci 2017;56(6):795-799.

The number of approved biosimilars in Europe is growing all the time1


  1. Adapted from Gherghescu I and Begoña Delgado-Charro M. The biosimilar landscape: An overview of regulatory approvals by the EMA and FDA. Pharmaceutics 2021;13:48.

Optimising treatment access and effect of price

Biologics account for a considerable portion of global medicine spending

Global spending US$, MAT Q2 2018


  1. Adapted from Gherghescu I and Begoña Delgado-Charro M. The biosimilar landscape: An overview of regulatory approvals by the EMA and FDA. Pharmaceutics 2021;13:48.

Biosimilars drive down price

Potential benefits of biosimilars: driving down price

Change in price per treatment day since introduction of biosimilar


  1. Adapted from Quintiles IMS. The impact of biosimilar competition in Europe. September 2018. Available at: Accessed July 2021

Biosimilar approvals have been increased in the past two years


Adapted from Ebbers H and Schellekens H. Drug Discov Today 2019;10:1963–1967

For more information on expanding treatment, please see the below video:

Examples of successful switching programmes Part 3

07/05/2021 | 52:37


Biosimilarity is demonstrated through extensive structural and functional comparability studies and a tailored clinical program

A biosimilar may receive regulatory approval based on comprehensive comparability exercise

Figure adapted from Araújo FC, et al. Pharmacol Res 2019;149:104467. 

PD, pharmacodynamics; PK, pharmacokinetic



Adapted from Araújo FC, et al. Pharmacol Res 2019; 149:104467.

Clinical programme

Clinical trials are tailored to confirm biosimilarity and to address any questions that may remain from previous analytical or functional studies

Comparative pharmacokinetic/pharmacodynamic studies

Comparative clinical efficacy and safety trial studies

  • Usually designed to demonstrate equivalent efficacy
  • To exclude clinically meaningful differences in safety and immunogenicity


Biosimilars in the EU: Information guide for healthcare professionals. Available from: Accessed July 2021

Clinical studies comparing a biosimilar to its reference product should be performed in sensitive indications

“The study population should generally be representative of approved therapeutic indication(s) of the reference product and be sensitive for detecting potential differences between the biosimilar and the reference”


Adapted from EMA. Guideline on similar biological medicinal products. 18 December 2014. Available from: Accessed July 2021

Biosimilars approved through this very stringent regulatory pathway can be considered as therapeutic alternatives to the reference products

For more information on totality of evidence, please see the following publication:

Biosimilars in the EU: Information Guide for Healthcare Professionals

Consensus Information Paper 2019. European Medicines Agency (EMA). Biosimilars in the EU: Information guide for healthcare professionals

Since the EU approved the first biosimilar medicine (‘biosimilar’) in 2006, the EU has pioneered the regulation of biosimilars. Over the past 10 years, the EU has approved the highest number of biosimilars worldwide, amassing considerable experience of their use and safety.
This guide has been jointly developed by the EMA and European commission with the objective of providing healthcare professionals with reference information on both the science and regulation underpinning the use of biosimilars.

Regulation of Biosimilar Medicines and Current Perspectives on Interchangeability and Policy

Eur J Clin Pharmacol 2019;75(1):1-11

The differences between FDA and EMA interchangeability recommendations for biosimilar therapeutics are discussed in this review. USA federal policy is contrasted with that of the EMA – ‘interchangeable products’ are evaluated in the former, whereas the EMA does not assess interchangeability. Policies promoting the use of biosimilar medicines in a number of European countries, the USA and Australia are discussed.

Authorized Manufacturing Changes of Therapeutic Monoclonal Antibodies (mAbs) in European Public Assessment Report (EPAR) Documents

Curr Med Res Opin 2016;32:829–34

This study investigated number and types of manufacturing changes for originator monoclonal antibodies based on European Public Assessment Report documentation and ascertained the level of risk these changes might impart. The study highlighted EMA's significant experience of process changes for originator monoclonal antibodies and the impact they may have on the efficacy and safety of biologicals. This experience is valuable for biosimilar product development.