
In fact, there can be variations of acceptable range within the same manufacturing process because biologics are processed using living cell-based technology and the make of these agents is not easily identifiable.
For this reason, they are also highly sensitive to storage and handling processes and typically have a shorter shelf life than your average oral medications. So, why research, develop, and ultimately manufacturer such complex, sometimes costly medications you might ask?
Tyrone's Commentary:
We've seen this movie before, haven't we? Much like small molecule generic equivalents, biosimilars are a big threat to biologic market share. It just takes time.
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Source: Generic Pharmaceutical Association annual savings and access report |
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