PHRM 3600: Final Exam With
Correct Solution
Which aspects of a bio similar must be the same as the reference product? - ANSWER
conditions of use
route of administration
strength
taste
color
What process is chemical synthesis commonly used in? - ANSWER generic/small
molecule synthesis
Why do biologics have increased problems with immunogenicity? - ANSWER
manufactured in living cells (often hamster and bacteria), which introduce immunogenic
materials
cannot readily predict immunogenic responses
body can readily detect and react to foreign protein biologics
common differences between biosimilars - ANSWER aggregation
impurities
structure
stability
immunogenicity
What are the 2 approved biosimilars? - ANSWER Zarxio (filgrastim-sndz)
Inflectra (Remicade-xxxx)
What was the first biologic used in therapy? - ANSWER rhInsulin
What are some post-translational modifications of bio similar products? - ANSWER
PEGylation and glycosylation
alter receptor binding, efficacy, and duration
, Which law was critical for bringing biosimilars quickly to the market with reduced FDA
restrictions? - ANSWER Patient Protection and Affordable Care Act
Which law established "generics"? - ANSWER Hatch-Waxman Act
The term "bio equivalence" is usually applied to - ANSWER small molecules
reference therapeutic - ANSWER the original biologic or small molecule approved for
use
innovator - ANSWER the original biologic or small molecule approved for use
interchangeable - ANSWER drug that has been approved to be substituted for the
reference product without intervention of the healthcare provider who prescribed the
reference product
aka generic
generic - ANSWER bioequivalent drug that has the same active ingredient, strength,
dosage form, route of administration, and condition of use
IND - ANSWER investigational new drug
NDA - ANSWER new drug application
What was the first bio similar? - ANSWER filgrastim-sndz (Zarxio)
reference - neupogen
What is filgrastim (Neupogen) used for? - ANSWER used in neutropenia to boost WBC
counts
What is infliximab (Remicade) used for? - ANSWER RA, Chron's disease, UC, plaque
psoriasis, ankylosing spondylitis, psoriatic arthritis
What is adalimumab (Humira) used for? - ANSWER RA, Chron's disease, plaque
psoriasis, ankylosing spondylitis, psoriatic arthritis
What is entanercept (Enbrel) used for? - ANSWER RA, plaque psoriasis, psoriatic
arthritis
What is bevacizumab (Avastin) used for? - ANSWER breast, colorectal, kidney, NSC
lung, glioblastoma, and ovarian cancers
What is epoein alpha (Epogen) used for? - ANSWER erythropoietin, anemia
What is pegfilgrastim (Neulasta) used for? - ANSWER neutropenia related to
chemotherapy
What is rituximab (Rituxan) used for? - ANSWER non-Hodgkin's lymphoma, chronic
lymphocytic leukemia, RA
Correct Solution
Which aspects of a bio similar must be the same as the reference product? - ANSWER
conditions of use
route of administration
strength
taste
color
What process is chemical synthesis commonly used in? - ANSWER generic/small
molecule synthesis
Why do biologics have increased problems with immunogenicity? - ANSWER
manufactured in living cells (often hamster and bacteria), which introduce immunogenic
materials
cannot readily predict immunogenic responses
body can readily detect and react to foreign protein biologics
common differences between biosimilars - ANSWER aggregation
impurities
structure
stability
immunogenicity
What are the 2 approved biosimilars? - ANSWER Zarxio (filgrastim-sndz)
Inflectra (Remicade-xxxx)
What was the first biologic used in therapy? - ANSWER rhInsulin
What are some post-translational modifications of bio similar products? - ANSWER
PEGylation and glycosylation
alter receptor binding, efficacy, and duration
, Which law was critical for bringing biosimilars quickly to the market with reduced FDA
restrictions? - ANSWER Patient Protection and Affordable Care Act
Which law established "generics"? - ANSWER Hatch-Waxman Act
The term "bio equivalence" is usually applied to - ANSWER small molecules
reference therapeutic - ANSWER the original biologic or small molecule approved for
use
innovator - ANSWER the original biologic or small molecule approved for use
interchangeable - ANSWER drug that has been approved to be substituted for the
reference product without intervention of the healthcare provider who prescribed the
reference product
aka generic
generic - ANSWER bioequivalent drug that has the same active ingredient, strength,
dosage form, route of administration, and condition of use
IND - ANSWER investigational new drug
NDA - ANSWER new drug application
What was the first bio similar? - ANSWER filgrastim-sndz (Zarxio)
reference - neupogen
What is filgrastim (Neupogen) used for? - ANSWER used in neutropenia to boost WBC
counts
What is infliximab (Remicade) used for? - ANSWER RA, Chron's disease, UC, plaque
psoriasis, ankylosing spondylitis, psoriatic arthritis
What is adalimumab (Humira) used for? - ANSWER RA, Chron's disease, plaque
psoriasis, ankylosing spondylitis, psoriatic arthritis
What is entanercept (Enbrel) used for? - ANSWER RA, plaque psoriasis, psoriatic
arthritis
What is bevacizumab (Avastin) used for? - ANSWER breast, colorectal, kidney, NSC
lung, glioblastoma, and ovarian cancers
What is epoein alpha (Epogen) used for? - ANSWER erythropoietin, anemia
What is pegfilgrastim (Neulasta) used for? - ANSWER neutropenia related to
chemotherapy
What is rituximab (Rituxan) used for? - ANSWER non-Hodgkin's lymphoma, chronic
lymphocytic leukemia, RA
