<p>Unleashing the Power of India
Biosimilar is the term coined for protein drugs that are similar,
but not identical to, an existing product. Copies of
biopharmaceuticals (proteins) that can be made after the
patent on the original product has expired
Example: Epoetin, G-CSF, insulin, somatropin
Ÿ Biological drugs are far more complex than conventional small
molecule pharmaceutical products.
Ÿ The complexity of biological drugs also comes from the
elaborate manufacturing processes involved in their production.
Ÿ A major concern with biological drugs is immunogenicity,
Immunogenicity can be affected by various factors including
manufacturing processes and impurities.
Ÿ Marketing approval of biosimilars is a much more complicated
issue than approval of generic equivalents of conventional
Ÿ Stability requires special handling.
Ÿ Highly sensitive to manufacturing changes.
Ÿ Extensive clinical trials, including Phase I and Phase III studies.
Verifying similarity or comparability of a biosimilar with an
innovator product therefore requires much more than
demonstrating bioequivalence (which is sufficient for
conventional generic drugs.)
Ÿ As the complexity of the protein product increases, such as with
long-chain or heavily glycosylated proteins and monoclonal
antibodies, more clinical data are required to fully characterize
the clinical properties of biosimilars.
Ÿ Biosimilars are less stable than chemical based
pharmaceuticals and thus require cold chain distribution
and have a shorter shelf life. This increases the cost and
complexity of distribution.
Ÿ The cost of development will be significantly higher than
for chemical-based generics.
Ÿ The operating profit margin of traditional generic drugs is
roughly 20%, but depending on the biosimilar product,
profit margins have the potential to be somewhat higher,
as much as 30%.
Ÿ Treatment cost with biosimilars is lesser than innovators
Ÿ Biopharmaceuticals represent one of the