Biosimilars

Question 1

Biologic

Answer 1

• a substance that is made from a living organism or its products
• are developed in living systems, including bateria, yeast, and mammalian

Question 2

biosimilar

Answer 2

demonstrated to be a similar to a brand name drug already authorized for sale (known as the reference biologic drug)

Question 3

generics

Answer 3

• 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

Question 4

biosimilars

Answer 4

• 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)

Question 5

types of drugs with biosimilars

Answer 5

• Insulin
• Low molecular weight heprin
• biologics for diseases such as psoriasis, rheumatoid arthritis, crohn disease, ulcerative colitis (adalimumub)

Question 6

insulin biosimilar

Answer 6

insulin lispro, insulin aspart

Question 7

low molecular heprin biosimilar

Answer 7

enoxaparin