Biosimilar Development Criteria
30 Questions
0 Views

Choose a study mode

Play Quiz
Study Flashcards
Spaced Repetition
Chat to lesson

Podcast

Play an AI-generated podcast conversation about this lesson

Questions and Answers

What is the primary role of the Cε3 domain in IgE's interaction with its receptors?

  • Initiating the allergic cascade
  • Enabling the interaction with high-affinity receptors (correct)
  • Forming trimers with IgE molecules
  • Preventing the binding of complement

    • What is the effect of omalizumab binding to IgE on the allergic cascade?

  • It disrupts the allergic cascade (correct)
  • It amplifies the allergic response
  • It has no impact on the allergic cascade
  • It increases the production of IgE

    • What is the composition of the immune complexes formed by the binding of omalizumab to IgE?

  • Membrane-bound tetramers
  • Soluble trimeric or hexameric complexes (correct)
  • Insoluble monomers
  • Soluble dimers

    • Which cell types primarily express the high-affinity receptors (FcεRI) and low-affinity receptors (FcεRII/CD23) for IgE?

    <p>Eosinophils, basophils, and mast cells</p> Signup and view all the answers

    What is the reason for the stability of IgE/omalizumab aggregates?

    <p>The high affinity of omalizumab for IgE</p> Signup and view all the answers

    What is the consequence of the stability of IgE/omalizumab aggregates?

    <p>They are easily removable by the mononuclear phagocytic system</p> Signup and view all the answers

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

    <p>It allows for the production of highly pure and specific antibodies.</p> Signup and view all the answers

    What is the primary function of PCSK9 in the liver?

    <p>To bind to low-density lipoprotein (LDL) receptors, facilitating their degradation.</p> Signup and view all the answers

    What is the result of Evolocumab binding to PCSK9?

    <p>An increase in LDL receptors on the liver surface, enhancing the removal of LDL-C from the blood.</p> Signup and view all the answers

    What is the primary mechanism of action of Evolocumab?

    <p>It binds to PCSK9, inhibiting its ability to bind to LDL receptors.</p> Signup and view all the answers

    What is the class of antibody that Evolocumab belongs to?

    <p>Immunoglobulin G2 (IgG2) lambda.</p> Signup and view all the answers

    What is the primary indication for Evolocumab therapy?

    <p>Patients with conditions like familial hypercholesterolemia or those requiring additional LDL-C lowering beyond what can be achieved with diet and statin therapy alone.</p> Signup and view all the answers

    What is the primary influence of omalizumab's glycosylation on its pharmacokinetics?

    <p>Influencing its distribution and metabolism</p> Signup and view all the answers

    What is the characteristic of the molecular structure of IgE?

    <p>Comprising two identical light chains with a variable and a constant domain</p> Signup and view all the answers

    What is the primary function of the variable fragments (Fab) of IgE?

    <p>Binding to specific antigens</p> Signup and view all the answers

    What is the implication of omalizumab's glycosylation on its therapeutic efficacy and safety?

    <p>It requires careful consideration during its development and clinical evaluation</p> Signup and view all the answers

    What is the characteristic of the heavy chains of IgE?

    <p>Including a variable portion and a constant fragment</p> Signup and view all the answers

    What is the primary binding site of the constant region (Fc) of IgE?

    <p>IgE receptors</p> Signup and view all the answers

    What is the primary goal of the abbreviated pathway for FDA approval of biosimilars?

    <p>Demonstrating biosimilarity between the proposed biosimilar and its reference product</p> Signup and view all the answers

    What type of studies are required to validate the similar safety and effectiveness of both the biosimilar and the reference product?

    <p>Pharmacokinetic and pharmacodynamic comparability studies</p> Signup and view all the answers

    What is the primary purpose of nonclinical trials in the development of biosimilars?

    <p>To assess the safety and efficacy of the biosimilar in vivo</p> Signup and view all the answers

    What is the significance of structural and functional similarity in the development of biosimilars?

    <p>It confirms the biosimilar closely resembles the reference product in both structure and function</p> Signup and view all the answers

    What is the primary advantage of the FDA's abbreviated pathway for biosimilar approval?

    <p>It reduces the time and cost of development without compromising safety and effectiveness</p> Signup and view all the answers

    What is the primary focus of comparative clinical trials in the development of biosimilars?

    <p>To verify the clinical similarity between the biosimilar and the reference product</p> Signup and view all the answers

    What is the ranking of the binding ability to biotinylated rCD28/Fc among TGN1412, F(ab’)2, and Fab fragment?

    <p>TGN1412 &gt; F(ab’)2 &gt; Fab</p> Signup and view all the answers

    Which subclass of IgG showed brighter staining of lymphocytes than TGN1412 and IgG4 using Flow cytometry?

    <p>IgG2</p> Signup and view all the answers

    Which of the following Fcγ receptors showed a different binding pattern compared to the others?

    <p>NIB(28SA)-G2</p> Signup and view all the answers

    What is the optimal response of immobilized TGN1412 in terms of cytokine release and cell proliferation?

    <p>At a specific mAb concentration</p> Signup and view all the answers

    Which of the following IgG subclasses showed the highest maximum response in terms of cytokine release?

    <p>IgG2</p> Signup and view all the answers

    What is the difference in the response pattern of F(ab’)2 fragments compared to TGN1412?

    <p>F(ab’)2 showed lower cytokine release at low doses but increasing responses at higher doses</p> Signup and view all the answers

    More Like This

    Use Quizgecko on...
    Browser
    Open
    Browser
    Browser