A product approved or on track for approval through abbreviated approval pathways in the U.S., Europe and other countries, based largely on similarities and comparisons with an already-approved reference biologic product.
Glossary
Biosimilar
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Ampoule (Ampule)
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HME
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Validation
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APIs
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Toxicology
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GDUFA
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Inspections
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Capsules
Microcapsule
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Wurster Process
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