ACPE UAN: 0475-0000-23-011-L04-P - A knowledge-based activity
ACPE logo The European Association of Hospital Pharmacists (EAHP) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
More information: https://www.eahp.eu/congresses/acpe
Self-assessment questions:

Question Title

* 1. The existence of differences between the reference product and its nanosimilar, as shown in comprehensive analytical characterization studies, is considered a definite exclusion criterion for receiving a marketing authorization.

Question Title

* 2. When evaluating a nanomedicine (or a respective nanosimilar) for hospital formulary inclusion, Drug&Therapeutics Comittees should only take into account available safety data and the results of a stringent budget impact analysis.

Question Title

* 3. Pharmacovigilance requirements for nanosimilars are different to those of the respective reference product, as nanosimilars are considered a higher risk drug class with open questions regarding safety signals only detectable during post-marketing surveillance.

Synergy Satellite Event: Non-Biologic Complex Drugs (and nano medicines)

Link to EAHP Statements
Section 2 - Selection, Procurement and Distribution: Statements - 2.2
Section 4 - Clinical Pharmacy Services: Statements - 4.6
Section 5 - Production and Compounding: Statements - 5.9; 5.11
Section 6 - Education and Research: Statements - 6.4

ACPE UAN: 0475-0000-23-011-L04-P - A knowledge-based activity

Abstract
Non-Biological Complex Drugs (NBCDs) are drugs that comprise large high molecular weight molecules and, often, nanoparticles structures. In this category we currently include glatiramoids, iron oxide carbohydrate nanoparticles, liposomes, and polymeric micelles.

They differ from typical small chemical molecules, generally used as pharmaceutical active product ingredients and also from biotechnology-derived medicinal products (large proteins). For NBCDs, the entire complex is the active pharmaceutical ingredient and its properties cannot be fully characterised by physicochemical analysis.

NBCDs can also be characterised as complex drug products not being biologicals!

A recent appraisal of approval procedures for NBCDs “follow-on products” approved in Europe shows a diversity of regulatory pathways being followed (generic, hybrid or biosimilar) that must be discussed in order to incorporate the enlarged community of follow-on NBCD products that will enter the market.

The hospital pharmacist must be aware of the importance of clinical trials comparing the innovators and similar products in order to anticipate side events or any effectiveness gap. Most of these medicinal products (recombinant hepatitis B or HPV vaccines, ferric carboxymaltose, high molecular weight iron dextran, nab-paclitaxel, glatiramer acetate, liposomal doxorubicin or vincristine, aprepitant, paliperidone - some of NBCDs) will have to be managed in a hospital setting, which is why the interdisciplinary pharmacotherapy committees need to consider all levels of evidence generated, focusing specifically on data related to clinical safety and efficacy comparability, discussing interchangeability decisions more like a biosimilar than a generic approach.

Learning objectives
After this synergy, participants should be able to:
  • Explain their newly acquired understanding of the Non-Biological Complex Drugs
  • Describe how pharmacists must be involved in NBCD evaluation
  • Understand the different approvals pathways of NBCD
  • List examples of NBCD
Educational need addressed
Hospital pharmacist should recognize that therapeutic equivalence is a critical question to NBCD´s and will be more challenging when so many nanomedicines, nanoimaging agents and new drugs, that must be considered NBCD, will enter the market.

Keywords: Non Biologic Complex Drugs, characterization, evaluation, interchangeability

T