D8 Biosimilars: Understanding the issues

Monday 29 August 2016
Hilton Buenos Aires : Atlantico A & B, 1.5 hours

Organised by the FIP Industrial Pharmacy Section and the FIP Special Interest Group on Biotechnology



Innovative medicinal products are authorised based on classical documentation of quality, efficacy and safety. When a patent expires, copies of the originator product can profit from an abbreviated and simplified procedure to get marketing authorisation once therapeutic equivalence is demonstrated.

Two small molecular entities are considered therapeutic equivalents and therefore interchangeable when:

  1. results of the pharmaceutical equivalence testing (quality) demonstrate they contain the same active ingredient(s), are of the same dosage form, route of administration and are identical in strength or concentration;
  2. results of the bioequivalence study (plasma concentration over time) are satisfactory in demonstrating their safety and effectiveness equivalence.

In the case of therapeutic proteins (large molecular entities), usually obtained through biotechnological methods, another paradigm for “generic versions” had to be developed, since the full characterisation of such complex products, usually, is not yet possible even under the use of state-of-the-art techniques.

Because of that, a whole set of scientific discussions drove the global development of guidelines and regulations aimed to accommodate scientific and economical concerns related to the question: How to promote the development of cheaper similar versions of the known high-cost biological drugs so that patients gain access to affordable products of reliable quality, safety and effectiveness?

Learning objectives

At the conclusion of this knowledge-based session, participants will be able to:

  1. Describe the global challenges and the pathways adopted by different national regulatory authorities (NRAs) for the regulation of biosimilars in developed and developing countries
  2. Describe the characteristics of clinical studies designed to demonstrate the interchangeability between two therapeutic protein products of biological origin
  3. Identify the specific supply chain aspects applied to biological products and assess the measures and tools available for the different stakeholders (manufacturers, governments, distributors, etc) to combat the counterfeiting of biological drug products
  4. Describe the overall impact of the biosimilars market on patients’ access to high-cost-medicines.


Igor Linhares de Castro (BiocadBrazil, Brazil) and Mathew Cherian (Hospira/Pfizer, USA)



1)      Trends and advances in global CMC and regulatory for biosimilars 

Carol Kirchhoff (Pfizer, USA)


2)      Clinical development of interchangeable therapeutic proteins 

Felipe Pinho (Sandoz, Brazil)


3)      Supply chain and anti-counterfeiting measures for biologics

Michael Anisfeld (Globepharm, USA)