Definition
A biosimilar is a biological medicine that is highly similar to an already-approved reference biologic, and its market entry often turns on patent disputes.
Why It Matters Legally
Biosimilar launches frequently trigger complex patent litigation over a thicket of patents covering the original biologic. The timing of these disputes can be worth billions to both sides.
Example Use Case
A company seeking to launch a biosimilar must navigate and challenge multiple patents protecting the original biologic drug.
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Related Terms
Patent Thicket, Patent Litigation, Pharmaceutical Patent, Patent Term, Patent Validity