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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
A biopharmaceutical (or “biological medical product”) is
a pharmaceutical product that contains
biotechnology-derived proteins as an active substance.
Biopharmaceuticals are reported to make up some 10 per
cent of the pharmaceuticals market, with many new
products in the pipeline. Sales of biopharmaceuticals
currently amount to over $ 30 billion in the United
States alone. This figure is increasing as other complex
biological medicines are being manufactured and marketed
to help in the treatment of many diseases. The four main
biopharmaceuticals accounting for the majority of sales
are epoetin, insulin, growth hormone (GH), and
granulocyte colony stimulating factor (G-CSF), but
several other cytokines, antibodies and hormones are
also available. Biopharmaceuticals make up a large
proportion of new medicines and many are being developed
using the same technology that is used to produce
vaccines. Advances over the last quarter of a century in
recombinant DNA technology have allowed the large-scale
manufacture of biologically-engineered proteins within
living cells. Many of the patents to these products are
now close to expiring or have already expired, and
manufacturers of so-called copycat pharmaceuticals are
attempting to expedite the production of follow-on
biopharmaceuticals, termed biosimilars.
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