[Ip-health] France blocks generic biologics

[Benjamin Krohmal]

http://www.in-pharmatechnologist.com/news/ng.asp?n=3D74296-france-
europe-biosimilar-legislation-generic

in-Pharma Technologist.com

French law disallows 'generic' biosimilars

by Anna Lewcock
19/02/2007- The French Parliament has adopted legislation which
prevents biosimilar medicinal products from being classed as generics
and bans the automatic substitution of one biological medicine for
another.

The community code relating to medicinal products for human use
(European Directive 2004/27/EC) has been transposed into French law,
and will be published before the beginning of March this year.

The legislation, which has been supported by the European
biopharmaceutical industry, takes a cautionary stance in regard to
the prickly debate regarding whether so-called biosimilar drugs can
really be considered generics in the same way as chemical compounds
can be.


The new law to be introduced in France establishes a legal definition
of "biosimilar" medicines that notes the potential variability of the
active substance and differences in the manufacturing process that
prevent the classification of biosimilars as strictly generic
products. Under the new rules, regulatory approval of biosimilars
will require additional pre-clinical and clinical data.


Biological medicines are produced using a living system or organism,
and their constituent molecules tend to be much larger and more
complex than the relatively simple molecular structure of chemically
synthesised traditional medicines.


Biosimilar medicines are intended to have the same mechanism of
action as the original biological medicine and treat the same
disease. However, there has been considerable debate surrounding the
labelling of these biosimilars as generics, as the complex nature of
the manufacturing process and the molecules themselves means that it
cannot be guaranteed that they are absolutely identical to the
original product.


"Analytical and preclinical tests are not sufficient to demonstrate
the sameness of two biological products or that they are identical,"
says the European Association for Bioindustries.


In addition, due to the fact that biosimilar medicines are not
completely identical to the biotech reference products, the new
French legislation also forbids the automatic substitution of one
biological medicine for another at the pharmacy level without the
express consent of the prescribing physician.


"A major concern when using biotech medicines is patient safety and
drug efficacy," said Dr Carlo Incerti, president of European
Biopharmaceutical Enterprises.


"Because biosimilars are not exact copies of the reference products,
they cannot have the exact same safety profile as the original
biotech medicine."


For example, last year Swiss pharmaceutical company BioPartners was
granted approval for Valtropin, a biosimilar version of the human
growth hormone somatropin. The product, however, has slightly
different precautions and warnings to the reference product, Eli
Lilly's Humatrope (somatropin), and is also produced using yeast as
opposed to E.Coli which could lead to clinical complications in some
patients.


In a climate of ever-increasing pressure to cut costs and seek out
cheaper alternatives to expensive drug treatments, there have been
calls to approve biosimilar products which can be cheaper than the
original innovator products.


According to the European Generic Medicines Association, the first
full wave of biosimilar medicines (only six products =96 somatropin,
interferon alpha, interferon beta, insulin, erythropoietin, and
granulocyte-colony stimulating factor) will generate savings of
around =802bn-=803bn a year.


However, due to underlying concerns regarding the possibility of
adverse immunogenic responses in patients treated with biological
products, pharmaceutical legislation regarding biologicals and
biosimilars has taken a precautionary approach in an attempt to
safeguard against possible unforeseen reactions.


The EU Directive was published back in 2004 with the deadline for
countries to transpose it into law by November 2005. France is
trailing behind, with around three quarters of member states having
already complied with the directive. By finally implementing the new
law, France will be brought in line with European requirements
governing the definition of generic and biosimilar medicines, as well
as requirements concerning the granting of marketing authorisations
including data protection, and the labelling and packaging of medicines.