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Introduction:
Medicinal products developed from biotechnology
constitute an essential part of medicines available to
the patients today. In fact, biotechnology medicines or
medical treatments derived from biotechnology have
revolutionized cancer care therapy. They represent
significant proportion of the currently available
pharmaceuticals. Moreover, approximately one third of
products in the drug discovery process are from
biotechnology origin. Much of the work is going in the
oncology area.
When patent of a drug expires, other companies make
copies of drugs (called generic drugs). A generic drug
is a copy of brand-name drug in terms of similar dosage,
safety, strength, how it is taken, quality, performance
and intended use. Before approving a generic drug
product, drug regulatory authorities require many
rigorous tests and procedures to assure that the generic
drug can be substituted for the brand name drug. As for
all other medicines, some major biotechnology-derived
medicines are, or will soon, no longer be protected by
patents and they will become open to development and
manufacture by other companies. Such copy of
biotechnology medicines is called biosimilars (in
Eurpean Union) or biogenerics or biopharmaceutical
medicines or biopharmaceuticals or follow-on protein
products (in US and Japan) or subsequent-entry biologics
(in Canada). Currently, there is controversy over the
terminology with a number of terms put forward. European
regulatory authorities have adopted the term 'biosimilars,'
while the US FDA prefers the term 'follow-on biologics.'
However, these terms are not used as synonyms for
'generics,' and already there are efforts going on to
prevent classification of these products as 'generics.'
In this article, most widely used term biosimilar has
been used. Biosimilars are medicines which are similar
to the original medicine, but due to the complexity of
biotechnology medicines they are not an identical copy
of the original product.
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