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The practical effect is that biosimilar developers operate with substantially less pre-investment visibility into patent risk than their generic drug counterparts — a key reason why the biosimilar market has matured more slowly than the generic drug market despite being launched with similar policy intent
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If you step down, do it in stages, hold each step at least 4 weeks to reach steady state before judging it, and treat a sustained upward trend over 8–12 weeks as a signal to step back up
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