Biosimilar Development Criteria

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?

Eosinophils, basophils, and mast cells (C) Signup and view all the answers

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

The high affinity of omalizumab for IgE (D) Signup and view all the answers

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

They are easily removable by the mononuclear phagocytic system (C) Signup and view all the answers

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

It allows for the production of highly pure and specific antibodies. (D) Signup and view all the answers

What is the primary function of PCSK9 in the liver?

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

What is the result of Evolocumab binding to PCSK9?

An increase in LDL receptors on the liver surface, enhancing the removal of LDL-C from the blood. (B) Signup and view all the answers

What is the primary mechanism of action of Evolocumab?

It binds to PCSK9, inhibiting its ability to bind to LDL receptors. (B) Signup and view all the answers

What is the class of antibody that Evolocumab belongs to?

Immunoglobulin G2 (IgG2) lambda. (B) Signup and view all the answers

What is the primary indication for Evolocumab therapy?

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

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

Influencing its distribution and metabolism (A) Signup and view all the answers

What is the characteristic of the molecular structure of IgE?

Comprising two identical light chains with a variable and a constant domain (B) Signup and view all the answers

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

Binding to specific antigens (B) Signup and view all the answers

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

It requires careful consideration during its development and clinical evaluation (C) Signup and view all the answers

What is the characteristic of the heavy chains of IgE?

Including a variable portion and a constant fragment (A) Signup and view all the answers

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

IgE receptors (A) Signup and view all the answers

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

Demonstrating biosimilarity between the proposed biosimilar and its reference product (C) 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?

Pharmacokinetic and pharmacodynamic comparability studies (B) Signup and view all the answers

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

To assess the safety and efficacy of the biosimilar in vivo (D) Signup and view all the answers

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

It confirms the biosimilar closely resembles the reference product in both structure and function (B) Signup and view all the answers

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

It reduces the time and cost of development without compromising safety and effectiveness (A) Signup and view all the answers

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

To verify the clinical similarity between the biosimilar and the reference product (A) 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?

TGN1412 > F(ab’)2 > Fab (B) Signup and view all the answers

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

IgG2 (C) Signup and view all the answers

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

NIB(28SA)-G2 (B) Signup and view all the answers

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

At a specific mAb concentration (D) Signup and view all the answers

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

IgG2 (D) Signup and view all the answers

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

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