ESOP certified education about biosimilars

Genetically engineered products were first introduced in 1982 with insulin. Since 2006, imitation products, so-called biosimilars, entered the pharmaceutical market. Biosimilars emerged in the past years with the expiration of the patent period of these drugs. Biosimilars are large, complex molecules that are similar but not identical to their classical pharmaceutical equivalents. Their preparation is laborious and costly, and barriers must be overcome for their approval. Immunogenicity issues are also associated with the use of biosimilars. The safety of biosimilars needs to be carefully and constantly monitored. Nonetheless, biosimilars are a critical element in the cost-effective use of biopharmaceuticals with a benefit both for patients and the healthcare system.

To meet up with today’s needs on biosimilars, ESOP has developed a training program on biosimilars. The program includes information on biosimilars, current guidelines and recommended handling procedures for biosimilars.

Delivery of this program is based on: webinars by professionals in the field; regional lectures at scientific conferences in each participating country; and case discussions. A certificate will be given on completion of the training program.

Learning Objectives

  • Explain the importance of analytical work in the development of biosimilars and regulatory approvals.
  • Descriptions of the concepts of extrapolation of immunogenicity and indications based on the integrity of the evidence
  • To assess the importance of access to pharmacoeconomic and biosimilars in oncology in Europe.
  • Summarise the current and emerging data on oncology monoclonal antibody biosimilars and their potential to provide optimal combination therapy.

The goal of the ESOP certified program on biosimilars is to spread knowledge on the meaningful use of biosimilars. The program can be delivered in the national language of the country being given whilst still retaining the same content.


This training is aimed at oncology pharmacists interested in advancing their practice on treatment of cancer using biosimilars.

The training is based on 3 pillars:

1. Knowledge transfer through specialist lectures on the Internet completed with knowledge examinations (webinars).
Regional lectures at scientific conferences in each participating country
3. Finally, personal work meetings for the discussion of patient cases and personal exchange with certificate.

A total of 20 hours is scheduled for specialist pharmacists and 25 hours for medical specialists. Through this uniform training, which also provides national language lectures of the same content, the goal is taken to spread knowledge across the meaningful use of biosimilars.