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© 2014 MD Conference Express®
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- Jenny Powers
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The Role of Biosimilar and Orphan Drugs in Treating Patients with Rheumatologic Disease
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- Article
- Summary
- BIOSIMILARS ARE NOT COMPARABLE TO GENERIC DRUGS
- PATENT EXPIRATIONS AND ECONOMIC BENEFITS FOR MANUFACTURERS DRIVE BIOSIMILAR DEVELOPMENT
- CHANGES IN MANUFACTURE OF BIOPHARMACEUTICALS
- EMA AND FDA GUIDANCE ON BIOSIMILAR STUDIES
- CLINICAL TRIAL DESIGN SUPPORTING NEW DRUG LICENSING AND BIOSIMILARS DIFFERS
- EXTRAPOLATED DATA MAY BE USED TO SUPPORT BIOSIMILAR USE
- CONCERNS REGARDING BIOSIMILAR USE FOR PATIENTS AND RHEUMATOLOGISTS: SWITCHING VERSUS SUBSTITUTION OF BIOSIMILARS MAY REQUIRE FURTHER TESTING
- ORPHAN DRUGS IN RHEUMATOLOGIC DISEASES
- ANTICIPATED FINANCIAL LOSSES CAUSED REGULATORY AGENCIES TO PROVIDE FINANCIAL INCENTIVES TO DRUG COMPANIES
- REQUIREMENTS FOR ORPHAN DRUG STATUS
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