Biosimilars vs Original Drugs: Key Differences
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Questions and Answers

What is a major advantage of hybridoma technology in antibody production?

  • Labor-intensive animal maintenance
  • Highly pure and specific antibodies (correct)
  • Require multiple animal species for production
  • Limited production of monoclonal antibodies

What is the primary target of Evolocumab in reducing LDL cholesterol levels?

  • Proprotein convertase subtilisin/kexin type 9 (PCSK9) (correct)
  • LDL receptors on the liver surface
  • Liver cells producing LDL cholesterol
  • Low-density lipoprotein (LDL) in the blood

What is the effect of Evolocumab binding to PCSK9?

  • Inhibits the production of LDL cholesterol in the liver
  • Reduces the liver's ability to remove LDL cholesterol from the blood
  • Increases the degradation of LDL receptors on the liver surface
  • Enhances the removal of LDL cholesterol from the blood (correct)

What type of antibody is Evolocumab?

<p>Human monoclonal immunoglobulin G2 (IgG2) lambda (A)</p> Signup and view all the answers

What is the purpose of Evolocumab in patients with familial hypercholesterolemia?

<p>To enhance the removal of LDL cholesterol from the blood (A)</p> Signup and view all the answers

What is the primary function of PCSK9 in the liver?

<p>Binding to LDL receptors, facilitating their degradation (D)</p> Signup and view all the answers

What is the composition of the infliximab antibody?

<p>75% human-derived and 25% murine-derived (D)</p> Signup and view all the answers

What is the function of the glycosylation pattern in the Fc region of the infliximab antibody?

<p>It plays a crucial role in the antibody's effector mechanisms (B)</p> Signup and view all the answers

How does infliximab's Fab region interact with TNF-α?

<p>It interacts with a single TNF-α monomer within trimer complexes (B)</p> Signup and view all the answers

What is the significance of the complementary determining regions (CDRs) in infliximab's therapeutic efficacy?

<p>All six CDRs are required for effective antigen recognition (D)</p> Signup and view all the answers

What is the initial step in the production of infliximab antibodies?

<p>Immunizing a mouse with injections containing recombinant human TNF-α (A)</p> Signup and view all the answers

What is the role of the adjuvant in the murine A2 hybridoma development?

<p>It enhances the immune response to the antigen (C)</p> Signup and view all the answers

What is the primary mechanism by which PEG modifications increase the half-life of antibodies?

<p>By increasing hydrophilicity and reducing glomerular filtration (D)</p> Signup and view all the answers

What is the effect of glycans on antigenic epitopes in proteins?

<p>They conceal antigenic epitopes, thereby decreasing immunogenicity (B)</p> Signup and view all the answers

What is the result of substitution mutations in the constant region of the antibody, such as T250Q/M428L or M252Y/S254T/T256E?

<p>They improve effector functions but may increase immunogenicity (D)</p> Signup and view all the answers

What is the effect of decreasing the pI of the variable region on the clearance of IgG antibodies?

<p>It decreases the rate of fluid-phase pinocytosis (D)</p> Signup and view all the answers

What is the purpose of using only the Fab fragment of the antibody?

<p>To mitigate side effects (A)</p> Signup and view all the answers

What is the role of the neonatal Fc receptor (FcRn) in the clearance of IgG antibodies?

<p>It determines the half-life of IgG antibodies (C)</p> Signup and view all the answers

What is a key difference in the production method of biosimilars compared to generic drugs?

<p>Biosimilars use living systems, while generic drugs are chemically synthesized (B)</p> Signup and view all the answers

What is the primary reason for the higher risk of immunogenicity in biosimilars compared to generic drugs?

<p>The variation in the protein molecule during the biological manufacturing process (B)</p> Signup and view all the answers

What is the FDA requirement for biosimilar manufacturers?

<p>To demonstrate that there are no clinically meaningful differences between the biosimilar and the reference product in terms of safety, purity, and potency (A)</p> Signup and view all the answers

What is a potential consequence of immunogenicity in biosimilars?

<p>Reduced efficacy of the biosimilar (A)</p> Signup and view all the answers

What is a key difference between biosimilars and generic drugs in terms of their structural similarity to the reference product?

<p>Biosimilars have a highly similar primary amino acid sequence to the reference product (D)</p> Signup and view all the answers

Why is it important for clinicians to monitor and report suspected immunological responses to biosimilars?

<p>Because immunological responses may occur months after initiation (D)</p> Signup and view all the answers

What is a benefit of developing biosimilars compared to standard biologic development pathways?

<p>Less time, investment, and risks (A)</p> Signup and view all the answers

What is the type of monoclonal antibody that Trastuzumab is?

<p>Humanized IgG1 kappa (D)</p> Signup and view all the answers

Where is Trastuzumab produced?

<p>In mammalian cell (Chinese Hamster ovary) culture (C)</p> Signup and view all the answers

What is the target of Trastuzumab?

<p>The extracellular domain IV of the human epidermal growth factor receptor 2 (A)</p> Signup and view all the answers

What is the normal function of HER2?

<p>To regulate the development of many tissues (B)</p> Signup and view all the answers

What is the result of HER2 activation in breast cancer?

<p>Formation of homodimers or heterodimers with other EGFR proteins (B)</p> Signup and view all the answers

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