biosimilar
Near-identical therapeutic protein
A biosimilar is a medication highly similar to an already-approved biological drug, differing only in minor ways that don't affect safety or effectiveness.
Unlike generic versions of chemical drugs, which are identical copies, biosimilars are made from living cells and can't be perfectly replicated: The FDA approved a biosimilar to the arthritis drug Humira.
The term emphasizes similarity rather than sameness.
Drug fate in body
- efficacyAbility to produce results
- safetyFreedom from harm
- clinical trialsControlled health research experiments
- extrapolationExtending data beyond bounds
indications · endpoints · bioequivalence · patient outcomes · tolerability · dosing · head-to-head
One who initiates
- innovatorCreator of new methods
- monoclonal antibodiesIdentical lab-cloned immune proteins
- recombinantGenetically engineered combination
- cell linesPropagated cellular populations
bioreactor · purification · formulation · batch · protein folding · characterization · comparability · manufacturing
Reduction in expenditure
- market competitionFirms contending for sales
- healthcare accessAbility to obtain treatment
- affordabilityState of being purchasable
- pricingEstablishing monetary amounts charged
reimbursement · market share · uptake · adoption · payer · exclusivity · litigation · market entry
U.S. health regulator
- approvalFavorable opinion given
- guidelinesSuggested rules for behavior
- GMPManufacturing compliance framework
- quality controlMaintaining production standards
compliance · dossier · labeling · inspection · designation · review · interchangeability · naming convention
Exchange of one for another
- switchableAble to be exchanged
- state lawsLegislation enacted regionally
- formularyApproved medication inventory
- substitutableCapable of being exchanged
pharmacokinetics
Drug fate in body
- efficacyAbility to produce results
- safetyFreedom from harm
- clinical trialsControlled health research experiments
extrapolation · indications · endpoints · bioequivalence · patient outcomes · tolerability · dosing · head-to-head
originator
One who initiates
- innovatorCreator of new methods
- monoclonal antibodiesIdentical lab-cloned immune proteins
- recombinantGenetically engineered combination
cell lines · bioreactor · purification · formulation · batch · protein folding · characterization · comparability · manufacturing · upstream
cost savings
Reduction in expenditure
- market competitionFirms contending for sales
- healthcare accessAbility to obtain treatment
- affordabilityState of being purchasable
pricing · reimbursement · market share · uptake · adoption · payer · exclusivity · litigation · market entry · developing countries
FDA
U.S. health regulator
- approvalFavorable opinion given
- guidelinesSuggested rules for behavior
- GMPManufacturing compliance framework
quality control · compliance · dossier · labeling · inspection · designation · review · interchangeability · naming convention
substitution
Exchange of one for another
- switchableAble to be exchanged
- state lawsLegislation enacted regionally
- formularyApproved medication inventory