|
Biosimilars
There is a difference
between a biological and biosimilar medicine. A
biological medicine is a
medicine whose active
substance is made by or
derived from a living
organism. For example,
insulin can be produced
by a living organism (such
as a bacterium or a
yeast), which has been
given the gene that
enables it to produce
insulin.
A biosimilar medicine is
a medicine which is
similar to a biological
medicine that has
already been authorized
( ‘the biological
reference medicine’ ).
The active substance of
a biosimilar medicine is
similar to the
biological reference
medicine. Biosimilar and
biological reference
medicines are used in
general at the same dose
to treat the same
disease. Since biosimilars and
biologicals are similar
but not identical, the
decision to treat a
patient with a reference
or a biosimilar medicine
should be taken
following the opinion of
a qualified healthcare
professional.
The name, appearance and
packaging of a biosimilar medicine
differ to those of the
biological reference
medicine.
Related information
Biosimilar Medicinal
Products Working Group
The biosimilar medical products working group is focusing on rules for
evaluating and authorizing biosimilar medicinal products at European level
(pharmaceutical legislation and EMEA guidances).
The results of this
working group is the
Innovation-Oriented
Regulatory Framework for
Biosimilars (Regulations,
EMEA Guidelines,
National Legislation).
Chairman: Mr. Thomas BOLS
(Amgen)
Secretary: Ms. Michael LEADER (EuropaBio)
Related information
Archive
EMEA annex for guidance on comparability of medicinal products containing biotechnology-derived proteins as drug substance (30.07.02) (28/10/2003 | pdf - 191.5kb)
Directive 2001/83/EC on the Community code relating to medicinal products for human use (22.09.03) (28/10/2003 | pdf - 272.7kb)
Letter to the Members of the European Parliament - Pharmaceutical review (09/12/2003) (05/02/2004 | doc - 132.5kb)
EuropaBio comments on EMEA annex for "guidance on comparability containing biotech-derived proteins as drug substances" Ref. CPMP/3097/02 (22/10/2003 | doc - 48kb)
BIO position paper (22/10/2003 | doc - 26kb)
EuropaBio position paper on the definition of generic medicinal products as developed in the common position on the revision of Directive 2001/83/EC on the Community Code for Human Medicines (07/10/2003 | doc - 51.5kb)
Biological and biosimilar medicines.
(01/02/2005 | pdf - 591kb)
The Biotech Industry's Views on the Pharma Review Package (04/11/2003 | ppt - 888.5kb)
Questions and Answers (PHRMA) (22/10/2003 | doc - 63.5kb)
News - US - San Francisco Chronicle 27.06.02 (22/10/2003 | doc - 36.5kb)
EuropaBio Q and A on biosimilar medical products (29/09/2003 | doc - 65.5kb)
 back |
