Biosimilars Flashcards
Biologic
- a substance that is made from a living organism or its products
- are developed in living systems, including bateria, yeast, and mammalian
biosimilar
demonstrated to be a similar to a brand name drug already authorized for sale (known as the reference biologic drug)
generics
- small drug molecules
- chemically synthesized
- mechanism of action well understood
- can be duplicated exactly
- active ingredient is chemically IDENTICAL to reference product
- approved on the basis of analytical similarity and bioequivalence
- generally inert
biosimilars
- large complex molecule
- manufactured in living systems
- may not be well understood
- cannot duplicate EXACTLY
- active ingredient is HIGHLY SIMILAR to reference product
- approved on the basis of extensice in vitro comparability testing and reduced non-clinical and clinical comparability testing
- potential to induce antibody response (immunogenicity)
types of drugs with biosimilars
- Insulin
- Low molecular weight heprin
- biologics for diseases such as psoriasis, rheumatoid arthritis, crohn disease, ulcerative colitis (adalimumub)
insulin biosimilar
insulin lispro, insulin aspart
low molecular heprin biosimilar
enoxaparin
Albertas Biosimilar Initiative has expanded the use of biosimilars by replacing biologic drugs with their _______ versions whenever possible
biosimilar
enoxaparin biosimilars for thromboembolic disorders
- inclunax
- noromby
- redesca
Insulin lispro biosimilar for diabetes
Admelog
Insulin aspart biosimilar for diabetes
Trurapi
Adalimumab biosimilars
- amgevita
- hadlima
- hulio
- hyrimoz
- idacio
adalimumab and biosimilars are used to treat
- ankylosing spondylitis
- plaque psorasis
- hidradenitis suppurativa
- psoriatic arthritis
- crohns disease
- ulcerative colitis
are biosimilars safe and effective
yes
who is responsible for monitor the saftey, efficacy and qualityof all new drugs on the market including biologics and biosimilars
Health Canada
