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Current Regulatory and Legal Considerations for Follow‐On Biologics
Author(s) -
Kingham RF,
Lietzan E
Publication year - 2008
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2008.159
Subject(s) - clinical pharmacology , business , incentive , risk analysis (engineering) , balance (ability) , set (abstract data type) , pharmacology , microbiology and biotechnology , public economics , medicine , economics , computer science , biology , programming language , physical medicine and rehabilitation , microeconomics
As patents for the first generation of biotechnology‐derived medicines expire, regulators must develop standards for follow‐ons. Requirements for traditional generic drugs will often be insufficient because follow‐on biotechnology medicines will not be identical to reference products. Policymakers must also consider what products to include, how to set data requirements, whether to permit interchange of follow‐ons and reference products, what postmarket requirements to impose, and how to balance cost savings from follow‐ons against incentives for innovation. Clinical Pharmacology & Therapeutics (2008); 84 , 5, 633–635 doi: 10.1038/clpt.2008.159