Alzheimer's Disease and Therapeutic Antibodies
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Questions and Answers

What is the projected spend on Pegfilgrastim after the launch of biosimilars?

  • $1,383 m
  • $1,222 m
  • $172 m
  • $659 m (correct)
  • Which biosimilar corresponds to Infliximab?

  • Trazimera
  • Udenyca
  • Fluphila
  • Inflectra (correct)
  • What percentage saving is projected for Rituximab with the introduction of biosimilars?

  • 54 (correct)
  • 34
  • 51
  • 57
  • Which product has the highest current spending before biosimilar launch?

    <p>Bevacizumab (A)</p> Signup and view all the answers

    What is the expected savings from biosimilars in comparison to generics?

    <p>Over six times more savings (D)</p> Signup and view all the answers

    How much was the projected spend for Epoetin Alfa without biosimilars?

    <p>$558 m (B)</p> Signup and view all the answers

    Which is NOT a characteristic of therapeutic antibodies discussed?

    <p>Polyclonal antibodies are derived from a single cell line. (C)</p> Signup and view all the answers

    What is the projected spend for Bevacizumab after biosimilar launch?

    <p>$406 m (B)</p> Signup and view all the answers

    What is the primary consequence of the build-up of toxic fragments of APP in the brain?

    <p>Neuronal cell death (B)</p> Signup and view all the answers

    What is the role of gamma secretase in relation to APP?

    <p>To cleave APP into non-toxic fragments (B)</p> Signup and view all the answers

    Which method could potentially decrease the production of amyloid-beta in the brain?

    <p>Degrading mRNA of APP (A)</p> Signup and view all the answers

    How do mis-folded protein aggregates contribute to Alzheimer's disease?

    <p>They lead to protein aggregation and toxicity (C)</p> Signup and view all the answers

    What potential treatment strategy involves the use of antibodies in relation to A-beta?

    <p>Preventing aggregation and enhancing removal of A-beta (C)</p> Signup and view all the answers

    What is the significance of protein aggregation in the context of Alzheimer’s disease?

    <p>It correlates with the presence of neurodegenerative diseases (C)</p> Signup and view all the answers

    What challenge is associated with fixing the APP mutation as a treatment for Alzheimer's?

    <p>It requires precise genetic manipulation across the brain (A)</p> Signup and view all the answers

    Which enzyme's activity, when inhibited, could potentially prevent the generation of amyloid-beta?

    <p>Gamma secretase (B)</p> Signup and view all the answers

    Which therapeutic antibody is noted for showing promising efficacy and was approved in 2023?

    <p>Lecanemab (C)</p> Signup and view all the answers

    What distinguishes biosimilars from generic drugs?

    <p>Biosimilars are made from living cells and may vary in structure. (B)</p> Signup and view all the answers

    What is the first biosimilar that was approved in the US?

    <p>Filgrastim (A)</p> Signup and view all the answers

    How many biosimilars had been approved in the US by 2022?

    <p>39 (D)</p> Signup and view all the answers

    Which therapeutic antibody failed in clinical trials?

    <p>Gantenerumab (B)</p> Signup and view all the answers

    What is expected from biosimilars in terms of healthcare costs?

    <p>Save around 50% in total market spending. (A)</p> Signup and view all the answers

    Which of the following is true about the approval process for biosimilars?

    <p>They must demonstrate no clinically meaningful differences in safety and efficacy. (A)</p> Signup and view all the answers

    Which of these biosimilars took the longest to arrive on the market?

    <p>Retacrit (A)</p> Signup and view all the answers

    What common factor affects biosimilars compared to their reference products?

    <p>Biosimilars may have different manufacturing processes. (C)</p> Signup and view all the answers

    Which company's product was associated with the 2018 approval of Pegfilgrastim biosimilars?

    <p>Mylan (A)</p> Signup and view all the answers

    What is a common challenge when manufacturing biosimilars?

    <p>Maintaining the exact same attributes as the reference biologic. (C)</p> Signup and view all the answers

    Which antibody combination was developed by Biogen and Eisai?

    <p>Lecanemab and Aducanumab (A)</p> Signup and view all the answers

    What has been a significant factor in the approval and launch of biosimilars?

    <p>Patents of originators expiring. (B)</p> Signup and view all the answers

    What is one expected benefit of increasing the number of biosimilars on the market?

    <p>Boost competition and lower prices. (D)</p> Signup and view all the answers

    Flashcards

    Amyloid Precursor Protein (APP)

    A protein expressed in neurons; role is unclear.

    Gamma Secretase

    An enzyme that cleaves APP, producing non-toxic fragments.

    A-beta

    Toxic fragments produced when APP is mutated and cleaved abnormally.

    Protein Aggregation

    Clumping of mis-folded or disordered proteins, often linked to diseases.

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    Plaques

    Mis-folded protein aggregates in the brain associated with Alzheimer's.

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    Neuronal Cell Death

    Loss of nerve cells due to toxicity from A-beta and plaques.

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    siRNA Technology

    A method to degrade mRNA and decrease production of APP.

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    Therapeutic Antibodies

    Antibodies designed to bind to A-beta and enhance its removal from the brain.

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    Biosimilars

    Biological products highly similar to an already approved reference product.

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    Projected Savings from Biosimilars

    Savings expected after the introduction of biosimilars, significantly reducing costs.

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    Monoclonal Antibodies

    Antibodies made by identical immune cells that are clones of a unique parent cell.

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    Polyclonal Antibodies

    Antibodies produced by different plasma cell lineages, targeting multiple antigens.

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    Antibody Structure

    Composed of variable and constant regions, forming Y-shaped molecules.

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    Impact of Biosimilars on Market

    Biosimilars increase competition, leading to lower prices and greater access.

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    Vaccination Concept

    Administering a vaccine to induce immunity against diseases.

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    Lecanemab

    A promising therapeutic antibody for Alzheimer's, approved in 2023.

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    Difference from Generics

    Generics are identical to small molecule drugs; biosimilars are not identical to biologics.

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    Approval Requirement for Biosimilars

    Manufacturers must show no clinically meaningful differences from the original biologic.

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    First Biosimilar Approval

    The first US biosimilar was approved in 2015.

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    Biosimilar Market Growth

    As of 2022, 39 biosimilars were approved in the US.

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    Time to Market for Biosimilars

    Biosimilars typically arrive about 20 years after the original product's market launch.

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    Impact of Biosimilars on Drug Prices

    Biosimilars are expected to reduce total market spending by about 50%.

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    Lecanemab Brand Name

    Brand name for Lecanemab is Legembi.

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    Ongoing Clinical Trials

    Some biosimilars like Donenemab and Trontinemab are still in trials as of 2023.

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    Comparison to Generic Drugs

    Generics have the exact same molecular structure as brand-name drugs.

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    Biologics

    Drugs derived from living cells used in treatment.

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    Hybridoma Cell Line

    A cell line used to produce monoclonal antibodies.

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    Study Notes

    Alzheimer's Disease and Therapeutic Antibodies

    • Amyloid precursor protein (APP) is found in neurons. Its function isn't fully understood but it plays roles in nerve cells.
    • Normally, gamma secretase cleaves APP, creating non-toxic fragments.
    • Mutations in APP can lead to altered cleavage by gamma secretase, producing toxic A-beta fragments.
    • These toxic fragments aggregate outside nerve cells, forming plaques.
    • Plaque buildup is toxic, causing neuronal death and abnormal brain function, leading to Alzheimer's disease.
    • Treatments for Alzheimer's focus on reducing A-beta toxicity and plaque formation.

    Treating A-beta Overproduction

    • A-beta aggregates form plaques leading to Alzheimer's symptoms.
    • Genetic manipulation to correct APP mutations is possible but viability is uncertain.
    • Reducing APP production by degrading APP mRNA is a genetic approach, potentially using siRNA technology.
    • Inhibiting enzymes that create A-beta (e.g., gamma secretase) is another approach.
    • Increasing A-beta removal using antibodies that bind to A-beta and prevent aggregation is possible.

    Therapeutic Antibodies in Alzheimer's

    • Multiple A-beta/plaque-targeting therapeutic antibodies have been developed.
    • Some have proven failures, some promising efficacy, and others are still under clinical studies.
    • Lecanemab, developed by Biogen, reduced plaques and slowed cognitive decline and was approved in 2023.

    Biosimilars

    • Biosimilars are copycat versions of biological medicines.
    • Unlike small-molecule generics, biologics are often made in living cells, so precise duplication isn't always achievable.
    • Key difference between biosimilars and reference products - differences in binding sites, affinity, or other properties may exist even if the target is the same.
    • Biosimilar manufacturing processes are not easily replicated.
    • Biosimilars are similar (but not identical) to original biologics. Safety and efficacy must be proven before approval.
    • First US biosimilar was in 2015. By 2022, 39 were approved, 22 launched.

    Biosimilar Arrival Time

    • Biosimilars typically arrive on the market about 20 years after the reference product.
    • Data shows various arrival times for specific drugs and manufacturers.

    Biosimilar Impact on Market Price

    • Biosimilars are expected to significantly reduce drug costs (approx. 50% savings).
    • The potential savings are greater than the savings provided by generic small molecule drugs.

    Conclusion of Presentation and Summary

    • Overview of therapeutic antibodies, polyclonal and monoclonal antibodies, vaccination, and antibody structure.
    • Discussion of biosimilars and their market impact.
    • A list of key takeaways regarding antibodies, biosimilars and impacts.

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    Description

    This quiz focuses on the relationship between amyloid precursor protein (APP) and Alzheimer's disease. It explores how mutations in APP lead to toxic A-beta fragments and the various therapeutic strategies aimed at targeting this issue. Test your knowledge on the mechanisms and treatment options related to Alzheimer's disease.

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