Generic Biologics?
by Derek Lowe
1 Comment »
Salomon Stavchansky wrote @ April 23rd, 2007 at 2:44 pm
Derek,
You are correct that the complexity of protein pharmaceuticals is difficult and characterization of the molecules are not trivial. However, new analytical methodologies do allow for a fair evaluation of the macromolecules. What we should not forget that the primary therapeutic activity may still be possible even if molecular changes take place in the protein structure. Thus, we may not have biogenerics, but biosimilars may be a more realistic expectation, In fact, this is already happening in the market place with epo and growth hormone. The world will not wait until the regulatory agencies decide how to establish “similarity “of a protein It is not only a characterization problem, but also a clinical and statistical problem.
Sol
Sol.
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