Podcast summary: The first biosimilars were
released in Europe ten years ago and were based on biologics with fairly simple
structures. As technology and understanding expands, manufacturers are
approaching a more complex set of drugs; some critics worry that, while researchers
are able to easily map the sequence of proteins, the actual structure of a
biosimilar may have slight, undetected variations from its counterpart.
Industry experts, however, are confident that the advancement of the technology
used to compare the chemical makeups is so precise that any undetected
structural error would be too minor to impact the drug’s efficacy or safety.
Additional concerns stem around clinical trial requirements – while the
original biologic required rigorous testing with thousands of people, trials to
prove equivalence (rather than efficacy) are typically much smaller in nature.
On the other hand, equivalence studies are much more affordable, lending this
approach to the cost containment initiatives that make biosimilars attractive in
the first place. Further, regulatory agencies will also likely require
extensive additional evidence of drug similarities, supplementing required
trials, before any approvals are issued.
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