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That’s how the biologic revolution began: not with failure,
but with incomplete success.
And now, two decades later, we are living with the
consequences of what we chose to overlook at the start.
2.2 – The Approval Pipeline: Speed
Over Stability
Biologic drugs don’t arrive in clinics by accident. They
pass through a meticulously designed pipeline—a sequence
of preclinical studies, clinical trials, and regulatory
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