WASHINGTON, Nov. 13 /PRNewswire/ -- Biotechnology Industry Organization
(BIO) President and CEO Jim Greenwood today issued the following statement
regarding the World Health Organization's program on the selection of
International Nonproprietary Names (INN):
"Today, BIO presented its recommendations to the World Health
Organization (WHO) to assign a distinct nonproprietary name to each unique
biological product, including follow-on biologics ("biosimilars"). We are
associated with five other trade associations presenting one voice to the
WHO International Nonproprietary Names (INN) Programme. Along with European
Biopharmaceutical Enterprises, the European Federation of Pharmaceutical
Industries and Associations, EuropaBio, the International Federation of
Pharmaceutical Manufacturers and the Pharmaceutical Research and
Manufacturers of America, we acknowledge the WHO's efforts to consider
updating international naming conventions to account for the complexity of
biological products.
"A policy of assigning distinct names to biological products will best
satisfy the objectives of the WHO's Guidance on INN: 'the clear
identification, safe prescription and dispensing of medicines to patients,
and communication and exchange of information among health professionals
and scientists worldwide.'
"One of our concerns is that current requirements for naming and
labeling may lead to inappropriate assumptions about sameness and
interchangeability of biological medicines. Biological products are
different from traditional drugs in their complexity, development and
production processes, and each biological product is unique. Unlike
traditional generic drugs, follow-on biologics are not identical to the
reference product. In fact, the European Medicines Agency has stated that
'due to the complexity of biological/biotechnology-derived products the
generic approach is scientifically not appropriate for these products.'
"Unlike traditional generic drugs, follow-on biologics are also not
interchangeable with the reference product. Patients could respond very
differently to the innovative product and any biosimilar versions.
Inadvertent substitution of one version of a medicine for another could
have negative clinical consequences. If an adverse event occurs with a
biological medicine, it is critical that it be traced promptly to the
correct manufacturer. This tracing would be greatly facilitated if all
biological medicines had a distinct INN. Because physicians may use the INN
in prescribing and as an indicator of interchangeability, BIO agrees with
the FDA's assessment that 'it is important that patients and physicians be
aware that protein products with similar molecular composition may indeed
not be interchangeable,' and believes that assignment of distinct INNs to
biological medicines is essential.
"We strongly urge the WHO to act to provide each unique biological
product a distinct name."
BIO represents more than 1,100 biotechnology companies, academic
institutions, state biotechnology centers and related organizations across
the United States and 31 other nations. BIO members are involved in the
research and development of healthcare, agricultural, industrial and
environmental biotechnology products.
SOURCE Biotechnology Industry Organization
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Related links:
http://www.bio.org
CONTACT:
Jeff Joseph of BIO, +1-202-962-9230
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