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Abstract: Biotechnological derived products are
active substance of a number of biopharmaceutical drugs
and have revolutionised the treatment of many diseases.
A number of biopharmaceutical patents are due to expire
in the next few years, or have already expired. Hence,
the subsequent production of follow-on products or
biosimilars has aroused interest within the
pharmaceutical industry. The potential opportunity for
price reductions versus the originator's
biopharmaceuticals remains to be determined, as the
advantage of a slightly cheaper price may be outweighed
by the hypothetical increased risk of side-effects from
biosimilar molecules that are not exact copies of their
originators. This review focuses on the issues
surrounding biosimilars, including manufacturing,
quality control, clinical efficacy and side effects, and
how government and industry regulations are evolving to
deal with these topics. Part One of the review outlines
how biosimilars are different from small-molecule
chemical drugs and how copies of biopharmaceuticals
cannot be produced in a manner similar to generics.
Using approval of Omnitrope as an example, Part One of
the review focuses on how European regulators have
evolved some guidelines for approval of copies of
biopharmaceuticals, or biosimilars, after bogging down
in uncertainty for years. Part Two of the review traces
the evolution of regulatory guidelines for biosimilars
in United States, using approval of Omnitrope as an
example. The emerging trends in regulatory considers for
biopharmaceutical in United States have also been
reviewed.
Introduction
Biosimilars or Follow-on biologics are terms used to
describe officially approved new versions of innovator
biopharmaceutical products, following patent expiry.
Biosimilar is the term coined for protein drugs that are
similar, but not identical to, existing product. Unlike
the situation with non protein drugs it is not possible
to create an identical copy or 'generics' of biological
drugs: this is mainly due to the complex nature of
protein molecule. The fact that biosimilars are not
perfect copies of originators drugs they are created to
resemble has raised a series of questions concerning
their regulation, quality, safety. The term “biosimilar
medicine” comes from EU legislation governing the
approval process, but these products are also known as
“similar biological medicinal products”, “follow-on
biologics” and “biogenerics”. Biosimilars are the
closest thing that the biotech world has to generic
drugs. However, because biotech drugs are grown in
cultures, rather than constructed out of chemicals like
traditional pharma drugs, it is impossible to have a
generic version of a biotech drug that is an exact
reproduction of the original. This makes biosimilars
difficult.
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