L6 Flashcards
What are generics?
Copy of a licenced medicinal product which can be brought to market because market exclusivity of reference product has elapsed
What 5 things is the generic comparable to a branded/reference product?
Dosage form
Quality profile
Route of admin
Characteristics
Intended use
When can additional exclusivities be awarded?
for innovative developments (3-10yrs)
What 3 studies can be waived for generics?
Animal studies
Bioavailability
Clinical trial
What study is performed instead of those 3 additional studies?
Bioequivalence study - not even in patients
When is a generic deemed bioequivalent?
If rate & extent of absorption do not show a significant difference to ref. product OR extent of absorption does not show a sig. difference in rate that is intentional & not medically sig.
Why are biosimilars different to generics?
Biosimilars are a Version not a copy & paste of the approved product which is demonstrated to be similar in terms of quality, biological activity, safety & efficacy & any differences are of negligible clinical impact
Define biosimilar according to the EEA?
Biological medicinal product that contains a version of the active substance of an already authorized biological medicinal product
Why are exact copies of biologicals so difficult?
Batch to batch heterogeneity is a feature of all biological medicines
What are biosimilars only created for?
Highly purified & thoroughly characterised products
What similarities must the BS have in the EU?
Safety
Efficacy
Posology
Route of admin
What is a comparability exercise?
Demonstrate similarity to reference in terms of quality characteristics, biological activity, safety & efficacy
Once approved does the BS need to repeat the biosimilarity reference?
No
Define switching
Practice of exchanging one medicine for another medicine which will have same therapeutic effects
What is substitution?
Practice of dispensing an equivalent medicine instead of the specific one prescribed at dispenser without consenting prescriber
What is interchangeability?
Practice of changing a medicine for a different one that is expected to achieve the same clinical effect in a given clinical setting in any patients but only with agreement/involvement of prescriber
Does Irish legislation exclude biological products from substitution?
yes - pharmacists cannot substitute a reference product for a biosimilar or vice versa
What % of prescriptions do not get filled in the US?
31% - due to costs
What is pharmacoeconimcs?
Tool to help healthcare decision makers compare the costs & consequences of healthcare products, services or programmes to decide which will yield optimal outcome per euro spent
What is Reimbursement Status/Formulary’s?
Lists of interventions that will be funded by state healthcare/ health insurers
What does the Reimbursement Status require?
Evaluation of the value of the intervention at the proposed price point compared to the other available treatments
Are regulators involved in drug pricing?
No
Does the US government negotiate drug prices with pharmaceutical companies?
No
What do HTAs do?
Make decision on drug reimbursement & pricing
Decision based on assessments & appraisals of available evidence
