Podcast
Questions and Answers
What is the projected spend on Pegfilgrastim after the launch of biosimilars?
What is the projected spend on Pegfilgrastim after the launch of biosimilars?
Which biosimilar corresponds to Infliximab?
Which biosimilar corresponds to Infliximab?
What percentage saving is projected for Rituximab with the introduction of biosimilars?
What percentage saving is projected for Rituximab with the introduction of biosimilars?
Which product has the highest current spending before biosimilar launch?
Which product has the highest current spending before biosimilar launch?
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What is the expected savings from biosimilars in comparison to generics?
What is the expected savings from biosimilars in comparison to generics?
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How much was the projected spend for Epoetin Alfa without biosimilars?
How much was the projected spend for Epoetin Alfa without biosimilars?
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Which is NOT a characteristic of therapeutic antibodies discussed?
Which is NOT a characteristic of therapeutic antibodies discussed?
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What is the projected spend for Bevacizumab after biosimilar launch?
What is the projected spend for Bevacizumab after biosimilar launch?
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What is the primary consequence of the build-up of toxic fragments of APP in the brain?
What is the primary consequence of the build-up of toxic fragments of APP in the brain?
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What is the role of gamma secretase in relation to APP?
What is the role of gamma secretase in relation to APP?
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Which method could potentially decrease the production of amyloid-beta in the brain?
Which method could potentially decrease the production of amyloid-beta in the brain?
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How do mis-folded protein aggregates contribute to Alzheimer's disease?
How do mis-folded protein aggregates contribute to Alzheimer's disease?
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What potential treatment strategy involves the use of antibodies in relation to A-beta?
What potential treatment strategy involves the use of antibodies in relation to A-beta?
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What is the significance of protein aggregation in the context of Alzheimer’s disease?
What is the significance of protein aggregation in the context of Alzheimer’s disease?
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What challenge is associated with fixing the APP mutation as a treatment for Alzheimer's?
What challenge is associated with fixing the APP mutation as a treatment for Alzheimer's?
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Which enzyme's activity, when inhibited, could potentially prevent the generation of amyloid-beta?
Which enzyme's activity, when inhibited, could potentially prevent the generation of amyloid-beta?
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Which therapeutic antibody is noted for showing promising efficacy and was approved in 2023?
Which therapeutic antibody is noted for showing promising efficacy and was approved in 2023?
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What distinguishes biosimilars from generic drugs?
What distinguishes biosimilars from generic drugs?
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What is the first biosimilar that was approved in the US?
What is the first biosimilar that was approved in the US?
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How many biosimilars had been approved in the US by 2022?
How many biosimilars had been approved in the US by 2022?
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Which therapeutic antibody failed in clinical trials?
Which therapeutic antibody failed in clinical trials?
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What is expected from biosimilars in terms of healthcare costs?
What is expected from biosimilars in terms of healthcare costs?
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Which of the following is true about the approval process for biosimilars?
Which of the following is true about the approval process for biosimilars?
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Which of these biosimilars took the longest to arrive on the market?
Which of these biosimilars took the longest to arrive on the market?
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What common factor affects biosimilars compared to their reference products?
What common factor affects biosimilars compared to their reference products?
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Which company's product was associated with the 2018 approval of Pegfilgrastim biosimilars?
Which company's product was associated with the 2018 approval of Pegfilgrastim biosimilars?
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What is a common challenge when manufacturing biosimilars?
What is a common challenge when manufacturing biosimilars?
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Which antibody combination was developed by Biogen and Eisai?
Which antibody combination was developed by Biogen and Eisai?
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What has been a significant factor in the approval and launch of biosimilars?
What has been a significant factor in the approval and launch of biosimilars?
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What is one expected benefit of increasing the number of biosimilars on the market?
What is one expected benefit of increasing the number of biosimilars on the market?
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Flashcards
Amyloid Precursor Protein (APP)
Amyloid Precursor Protein (APP)
A protein expressed in neurons; role is unclear.
Gamma Secretase
Gamma Secretase
An enzyme that cleaves APP, producing non-toxic fragments.
A-beta
A-beta
Toxic fragments produced when APP is mutated and cleaved abnormally.
Protein Aggregation
Protein Aggregation
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Plaques
Plaques
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Neuronal Cell Death
Neuronal Cell Death
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siRNA Technology
siRNA Technology
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Therapeutic Antibodies
Therapeutic Antibodies
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Biosimilars
Biosimilars
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Projected Savings from Biosimilars
Projected Savings from Biosimilars
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Monoclonal Antibodies
Monoclonal Antibodies
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Polyclonal Antibodies
Polyclonal Antibodies
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Antibody Structure
Antibody Structure
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Impact of Biosimilars on Market
Impact of Biosimilars on Market
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Vaccination Concept
Vaccination Concept
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Lecanemab
Lecanemab
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Difference from Generics
Difference from Generics
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Approval Requirement for Biosimilars
Approval Requirement for Biosimilars
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First Biosimilar Approval
First Biosimilar Approval
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Biosimilar Market Growth
Biosimilar Market Growth
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Time to Market for Biosimilars
Time to Market for Biosimilars
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Impact of Biosimilars on Drug Prices
Impact of Biosimilars on Drug Prices
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Lecanemab Brand Name
Lecanemab Brand Name
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Ongoing Clinical Trials
Ongoing Clinical Trials
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Comparison to Generic Drugs
Comparison to Generic Drugs
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Biologics
Biologics
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Hybridoma Cell Line
Hybridoma Cell Line
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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.