Improving the understanding of biosimilar formulation science through Real-World Training

Theoretical and remote real-world training, in Italian and English, designed as a series of webinars, on the pharmacology, technology and stability of Monoclonal Antibodies, both originators and biosimilars, and related regulatory aspects.

Unimi Coordinator: Paola Minghetti

Scholars/Academics:

  • Danilo Giuseppe Norata, University of Milan
  • Francesca Selmin, University of Milan
  • Paolo Rocco, University of Milan
  • Vito Ladisa, Fondazione IRCCS Istituto Nazionale dei Tumori

Objectives:

The treatment of solid tumors is rapidly evolving and given the expertise accumulated with the use of biologics in cancer, national health systems in Western Europe envision that the treatment of solid tumors will not be solely restricted to centers of excellence but should soon extend to several care givers. This process which will be further sustained by the increasing availability of monoclonal antibody biosimilars.

In Italy and in other European countries, this will pose new challenges mainly on pharmacists as they will be the key health professionals to be responsible for compounding and handling oncology monoclonal antibody biosimilars. However, pharmacists working in peripheral or in middle to small hospitals have a poor background on key aspects influencing biologics preparation although these are critical to achieve a proper pharmacological response that translate in a clinical benefit for the patients.

The project aims at providing a fundamental grounding in the pharmacology and technology of Monoclonal Antibodies in oncology, both originators and biosimilars, and the methodology associated with their compounding and handling.

Target groups/Impact:

The primary target audience for this project consists of hospital pharmacists in the EU, though students in the specialization in Hospital Pharmacist and community pharmacists may benefit from the course. The overall population size in Europe exceeds 30,000 units, of which more than 2,000 are members of the Italian Hospital Pharmacists’ Association (SIFO - Società Italiana di Farmacia Ospedaliera).

Therefore, the Italian version of the course will reach the 2,000+ members of SIFO, through platforms for Pharmacist Continuous Education in Medicine. The English version of the course may potentially reach more than 30,000 hospital pharmacists through international platforms for Pharmacist Continuous Education in Medicine.

Type of agreement
Study field
Validity period
From 06-04-2021 To 05-10-2022