Pan-European survey calls for a shift in policy for biosimilars

18.03.2014

Pan-European survey calls for a shift in policy for biosimilars

 

Press release,

Brussels, 18 March 2014

 

Today, the Alliance for Safe Biologic Medicines (ASBM) disclosed the results of a survey of 470 European physicians, that took place in Q3 of 2013, across five EU countries (France, Germany, Italy, Spain, and the UK), regarding their prescribing habits and knowledge of biosimilar medicines. Participants in the survey included specialists in the fields of nephrology, rheumatology, dermatology, neurology, endocrinology and oncology. The results were released at a stakeholder roundtable hosted by EuropaBio, with representatives from physicians and patient groups, as well as industry and regulatory bodies.

 

One of the main findings of the survey relates to European physicians’ insufficient knowledge of biosimilars. Only 22% consider themselves as very familiar with this new category of medicines. Whilst a majority (54%) have a basic understanding of biosimilars, 24% of participants cannot define or have not heard about biosimilars before.

 

The findings stress that using the same International Non-Proprietary Name (INN) for two medicines (innovator biologic and biosimilar) can be misleading.  Firstly, this may lead to false attribution of adverse event if reporters only report the INN, but also it may give the wrong impression that these medicines are structurally identical (54% of those surveyed thought that the same INN meant the products were structurally identical).

 

Although the results showed that physicians prefer to use brand names when prescribing biological medicines and reporting adverse events, the findings around the use of INN and its meaning in the context of biosimilar products lead us to conclude that the use of distinguishable INN for all biologics, including biosimilars, is critical to further strengthen and facilitate patient safety through effective pharmacovigilance.

 

The survey also provides important information regarding substitution. 72% of prescribers consider it “Critical” or “Very Important” to decide whether a patient should receive an innovator biologic medicine or a biosimilar. As a consequence, 74% consider it “Critical” or “Very Important” that the mention of “Dispense as Written” on prescriptions should be respected, and 62% think that it is “not acceptable” for a pharmacist to determine which biologic medicine to dispense at initiation of treatment.

 

Michael Reilly, Executive Director of the ASBM, commented: “The ASBM survey is the first large-scale survey on biosimilars in Europe. It reflects the daily clinical practice with regards to biologic medicines including biosimilars, and provides facts and figures that put current international, EU as well as national policy developments in the field of naming and substitution into perspective.” He also added that“key findings of the survey show that 54% of physicians surveyed only have a basic understanding of biosimilars, and more concerning that 24% cannot define or have not heard about biosimilars before.”

 

Nathalie Moll, Secretary General of EuropaBio, added: “The results of the survey indicate that the understanding of biosimilars is not yet wide-spread among physicians. At the same time, doctors need to be fully aware of the characteristics of biologics and biosimilars to be in a position to prescribe the medicine that will maximise patient outcomes. In the coming months, EuropaBio shall commit to raising awareness, through an open dialogue with physicians and regulators, which will include workshops at member state level.”

 

ENDS

Link to the full report

Media Contact:

Rosalind Travers

Communications manager, EuropaBio

Email: r.travers@europabio.org

Ph: +32 (0) 2 739 1173/ +32 (0) 478 680 301

 

 

About EuropaBio:

EuropaBio is the European Association of BioIndustries. Our members are involved in research, development, testing, manufacturing and commercialisation of biotech products and processes in human and animal healthcare, diagnostics, bioinformatics, chemicals, crop protection, agriculture, food and environmental products and services. EuropaBio also counts a number of National Biotech Associations in its membership who in turn represent more than 1800 biotech SMEs.

 

 

About the Alliance for Safe Biologic Medicines:

The Alliance for Safe Biologic Medicines (ASBM) is an organisation composed of diverse healthcare groups and individuals from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.