Biosimilars vs Original Drugs: Key Differences

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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?

Human monoclonal immunoglobulin G2 (IgG2) lambda Signup and view all the answers

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

To enhance the removal of LDL cholesterol from the blood Signup and view all the answers

What is the primary function of PCSK9 in the liver?

Binding to LDL receptors, facilitating their degradation Signup and view all the answers

What is the composition of the infliximab antibody?

75% human-derived and 25% murine-derived Signup and view all the answers

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

It plays a crucial role in the antibody's effector mechanisms Signup and view all the answers

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

It interacts with a single TNF-α monomer within trimer complexes Signup and view all the answers

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

All six CDRs are required for effective antigen recognition Signup and view all the answers

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

Immunizing a mouse with injections containing recombinant human TNF-α Signup and view all the answers

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

It enhances the immune response to the antigen Signup and view all the answers

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

By increasing hydrophilicity and reducing glomerular filtration Signup and view all the answers

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

They conceal antigenic epitopes, thereby decreasing immunogenicity 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?

They improve effector functions but may increase immunogenicity Signup and view all the answers

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

It decreases the rate of fluid-phase pinocytosis Signup and view all the answers

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

To mitigate side effects Signup and view all the answers

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

It determines the half-life of IgG antibodies Signup and view all the answers

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

Biosimilars use living systems, while generic drugs are chemically synthesized Signup and view all the answers

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

The variation in the protein molecule during the biological manufacturing process Signup and view all the answers

What is the FDA requirement for biosimilar manufacturers?

To demonstrate that there are no clinically meaningful differences between the biosimilar and the reference product in terms of safety, purity, and potency Signup and view all the answers

What is a potential consequence of immunogenicity in biosimilars?

Reduced efficacy of the biosimilar 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?

Biosimilars have a highly similar primary amino acid sequence to the reference product Signup and view all the answers

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

Because immunological responses may occur months after initiation Signup and view all the answers

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

Less time, investment, and risks Signup and view all the answers

What is the type of monoclonal antibody that Trastuzumab is?

Humanized IgG1 kappa Signup and view all the answers

Where is Trastuzumab produced?

In mammalian cell (Chinese Hamster ovary) culture Signup and view all the answers

What is the target of Trastuzumab?

The extracellular domain IV of the human epidermal growth factor receptor 2 Signup and view all the answers

What is the normal function of HER2?

To regulate the development of many tissues Signup and view all the answers

What is the result of HER2 activation in breast cancer?

Formation of homodimers or heterodimers with other EGFR proteins Signup and view all the answers