Pharmaceutical Industry Overview Quiz
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Questions and Answers

Which of the following is a characteristic of generic drugs?

  • They are manufactured in laboratories using biological processes.
  • They are always more expensive than brand-name drugs.
  • They are copies that match brand-name drugs in safety and intended use. (correct)
  • They may have different active ingredients than brand-name drugs.

    • What distinguishes small molecule drugs from biologics?

  • Small molecule drugs are typically plant-based.
  • Small molecule drugs are manufactured in living systems.
  • Biologics often consist of large complex molecules. (correct)
  • Biologics have well-defined chemical structures.

    • What percentage of government expenditure on PBS was estimated for the year 2019-2020 in Australia?

  • 75%
  • 50%
  • 89% (correct)
  • 65%

    • Which of the following companies is NOT among the top pharmaceutical companies mentioned?

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

    Which term describes drugs that are produced with the process being part of their identity?

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

    Which statement best describes the role of 'Big Pharma'?

    <p>They are large pharmaceutical companies focused on research-based drugs.</p> Signup and view all the answers

    What is a common characteristic of non-research-based pharmaceutical companies?

    <p>They often engage in the production of generics.</p> Signup and view all the answers

    Which of the following best describes the relationship between originator drugs and generics?

    <p>Generics can only be developed after the originator drug's patent expires.</p> Signup and view all the answers

    Which drug had the highest lifetime sales in the pharmaceutical industry as of the latest data?

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

    What year did the patent for Humira expire?

    <p>2018</p> Signup and view all the answers

    Which company markets Keytruda?

    <p>Merck &amp; Co.</p> Signup and view all the answers

    What is the main therapy area for the drug Imbruvica?

    <p>Leukemia and Lymphoma</p> Signup and view all the answers

    Which drug was launched most recently according to the sales data?

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

    What key factor is highlighted as crucial for the Pharmaceutical Industry?

    <p>Risk management</p> Signup and view all the answers

    What was the annual sale figure for Eliquis in 2020?

    <p>$9.2 billion</p> Signup and view all the answers

    Which of the following statements is true regarding Lipitor?

    <p>Its patent expired in 2011.</p> Signup and view all the answers

    What is the first step in the drug discovery process?

    <p>Basic exploratory research</p> Signup and view all the answers

    How long does the preclinical stage typically last?

    <p>1 year</p> Signup and view all the answers

    How many compounds typically enter preclinical testing from the discovery phase?

    <p>250</p> Signup and view all the answers

    What is the typical duration of clinical trials?

    <p>6.5 years</p> Signup and view all the answers

    What must happen before a drug can be marketed?

    <p>Registration dossiers must be submitted to regulatory authorities</p> Signup and view all the answers

    Which agency is responsible for ensuring drug safety and efficacy in the United States?

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

    What is a significant financial aspect of drug development?

    <p>Costs for clinical trials exceed $2 billion</p> Signup and view all the answers

    In the drug development process, what is the primary goal of the clinical trials?

    <p>To confirm the drug's safety and efficacy</p> Signup and view all the answers

    How many drugs are typically approved for marketing out of those screened?

    <p>1 out of 5,000 to 10,000</p> Signup and view all the answers

    What is a key challenge in the drug commercialization process?

    <p>Establishing regulatory compliance</p> Signup and view all the answers

    What is the effective patent life for pharmaceuticals?

    <p>10-13 years</p> Signup and view all the answers

    Which of the following diseases is an example of one targeted by orphan drugs?

    <p>Cystic fibrosis</p> Signup and view all the answers

    Which stage of drug development is NOT conducted by generics?

    <p>Basic exploratory research</p> Signup and view all the answers

    How long is the standard patent term for pharmaceuticals, including possible extensions?

    <p>25 years</p> Signup and view all the answers

    What must a generic drug demonstrate to be marketed successfully?

    <p>Therapeutic equivalence or bioequivalence</p> Signup and view all the answers

    What is the primary focus of commercial attractiveness in drug development?

    <p>Potential sales and market demand</p> Signup and view all the answers

    Which of the following stages lasts the longest in the drug development process?

    <p>Clinical trials</p> Signup and view all the answers

    Which of the following statements is true about the patent owner's rights?

    <p>They have exclusive rights to commercially exploit the invention for the life of the patent.</p> Signup and view all the answers

    What percentage of drugs are estimated to generate enough revenue to cover their development costs?

    <p>30%</p> Signup and view all the answers

    Which category do most blockbuster drugs commonly target?

    <p>Highly prevalent chronic conditions</p> Signup and view all the answers

    Which of the following is NOT a characteristic of a blockbuster drug?

    <p>Used predominantly for acute illnesses</p> Signup and view all the answers

    Which drug had the highest peak year sales to 2013?

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

    In which year did Humira experience its peak sales?

    <p>2012</p> Signup and view all the answers

    Which of the following biopharmaceuticals is indicated for autoimmune diseases?

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

    What type of drug is Crestor?

    <p>Small molecule</p> Signup and view all the answers

    Which drug is used for treating asthma/COPD?

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

    Which of the following drugs had peak sales in 2010 and is indicated for hypertension?

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

    What is the common characteristic of the drugs Lipitor and Crestor?

    <p>Both are small molecules targeting dyslipidemia</p> Signup and view all the answers

    Study Notes

    Pharmaceutical Industry Overview

    • Top pharmaceutical companies include Bayer (Germany), Pfizer (USA), Gilead (USA), AstraZeneca (USA), Alphapharm (RSA), Boehringer (Germany), and Apotex (Canada).
    • Distinguishing between overseas and locally owned companies, and between research-based and non-research-based entities.

    Generic Drugs

    • Generic drugs must demonstrate equivalence to brand-name drugs in dosage, safety, strength, quality, and intended use.
    • Originator drugs undergo full research and development (R&D) processes, while generics avoid some phases, focusing on demonstrating therapeutic equivalence.

    Drug Types

    • Small molecules are chemically synthesized, easily analyzed, and have defined structures; can be generics.
    • Biologics are made using living systems; their complexity can complicate characterization, leading to biosimilars.

    Medicines in Australia

    • Approximately 209 million PBS (Pharmaceutical Benefits Scheme) prescriptions were issued in 2019-2020; around 55% originated from doctor visits.
    • Government spending on PBS exceeded $12.5 billion in the same period, covering nearly 89% of the total cost of prescriptions.

    Drug Development Phases

    • Drug discovery can take 4-8 years, focused on identifying therapeutic targets.
    • Preclinical testing involves a year of toxicity and safety assessments.
    • Clinical trials span 6.5 years, encompassing three testing phases for safety and efficacy.
    • Registration takes 1-2 years for regulatory review and approval before marketing begins.

    Drug Development Costs and Success Rates

    • Out of 5,000 to 10,000 compounds screened, only about 1 reaches the market, with development costs exceeding $2 billion.
    • The financial success of marketed drugs is vital for funding the R&D pipeline, with only 30% generating enough revenue to cover development costs.

    Blockbuster Drugs

    • Blockbusters are drugs generating over $1 billion annually, often standard treatments for chronic conditions.
    • Examples include Lipitor (Pfizer), Humira (AbbVie), and Advair (GSK), with lifetime sales reaching hundreds of billions pre-patent expiration.

    Patents and Intellectual Property

    • Standard patents last 20 years from filing, with a possible five-year extension for pharmaceuticals, leading to effective patent life of 10-13 years due to time to market.
    • Patent ownership grants exclusive commercial rights; details post-filing become public, enabling additional research by others.

    Orphan Drugs

    • Orphan drugs treat rare diseases affecting less than 5 individuals per 10,000; examples include cystic fibrosis and multiple myeloma.

    Commercial Considerations

    • Evaluating a drug project's feasibility involves assessing medical need, originality in research, market competition, and potential commercial attractiveness.
    • Concerns arise around disease mongering, where conditions are exaggerated for profit, leading to dubious marketing practices.

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    Description

    Test your knowledge on the pharmaceutical industry, including major companies and the differences between generic and brand-name drugs. Understand the types of drugs and the landscape of medicines in Australia. This quiz covers essential concepts and facts about drug development and distribution.

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