biosimilars
Near-identical biologic copies
Biosimilars are medications designed to closely replicate existing biological drugs whose patents have expired.
Unlike generic versions of simple chemical drugs, biologics are complex molecules derived from living cells, so biosimilars can only approximate—not exactly copy—the original.
They must demonstrate equivalent safety and effectiveness through clinical trials: The FDA approved several biosimilars for the cancer drug Herceptin.
Biosimilars typically cost less than their reference biologics, expanding patient access to expensive treatments.
U.S. health regulator
- approvalFavorable opinion given
- interchangeabilityQuality of being swappable
- extrapolationExtending data beyond bounds
- clinical trialsControlled health research experiments
Cancer medicine specialty
- rheumatologyConnective tissue medicine branch
- autoimmuneBody attacks itself
- inflammatory bowel diseaseChronic intestinal tract condition
- psoriasisImmune system attacks skin cells
rheumatoid arthritis · anemia · neutropenia · diabetes · macular degeneration · supportive care · monoclonal antibodies · growth factors
Drug fate in body
- bioequivalenceEqual drug delivery profile
- protein foldingChain becoming functional structure
- aggregationCombined collection of items
- formulationDevised mixture or expression
Reduction in expenditure
- affordabilityState of being purchasable
- market competitionFirms contending for sales
- pricingEstablishing monetary amounts charged
- reimbursementPayment for incurred expenses
formulary · exclusivity · market share · uptake · healthcare spending
FDA
U.S. health regulator
- approvalFavorable opinion given
- interchangeabilityQuality of being swappable
- extrapolationExtending data beyond bounds
clinical trials · naming convention · labeling · comparability
oncology
Cancer medicine specialty
- rheumatologyConnective tissue medicine branch
- autoimmuneBody attacks itself
- inflammatory bowel diseaseChronic intestinal tract condition
psoriasis · rheumatoid arthritis · anemia · neutropenia · diabetes · macular degeneration · supportive care · monoclonal antibodies · growth factors · hormones
originator
One who initiates
- HumiraTNF-blocking biologic drug
pharmacokinetics
Drug fate in body
- bioequivalenceEqual drug delivery profile
- protein foldingChain becoming functional structure
- aggregationCombined collection of items
cost savings
Reduction in expenditure
- affordabilityState of being purchasable
- market competitionFirms contending for sales
- pricingEstablishing monetary amounts charged
reimbursement · formulary · exclusivity · market share · uptake · healthcare spending
- medicationspills, Tylenol, capsules, tablets, Xanax
- BiotechDNA, bioengineering, genetic testing, gene, DNA sequencing
- Pharma Industrypharmaceuticals, biotech, drug discovery, clinical trials, vaccines
- pharmaceuticalsanalgesics, medicines, anesthetics, pills, acetaminophen
- Health Regulationdrug approval, drug safety, medical devices, product recalls, health warnings
- drug developmentdrug discovery, drug development, drug screening, drug delivery, FDA approval
similar, biology, similarity, biological, biographer, biopsy, biosphere, biodiversity, biodegradable