3.3.12 Biosimilar medicines

• What is a biologic?

     - A. A medicine made from synthetic sources

     - B. A medicine made from natural sources such as human, animal, or microorganism

     - C. A medicine made only from human sources

     - D. A medicine made from minerals and metals

  A medicine made from natural sources such as human, animal, or microorganism
• Which of the following is NOT an example of a biologic?

     - A. Blood and blood products

     - B. Synthetic antibiotics

     - C. Therapeutic proteins

     - D. DNA

  Synthetic antibiotics
• What distinguishes a biosimilar from a generic medicine?

     - A. Biosimilars are made from synthetic sources

     - B. Biosimilars are exact copies of the originator biologic

     - C. Biosimilars have similar quality, safety, and efficacy as the originator biologic

     - D. Biosimilars are cheaper than generic medicines

  Biosimilars have similar quality, safety, and efficacy as the originator biologic
• Why can't biosimilars be identical to the originator biologic?

     - A. Because biosimilars are made from different sources

     - B. Due to the small size of biologic molecules

     - C. Because it's not possible to characterise a biologic to the same extent as a small molecule drug

     - D. Biosimilars are inherently less effective

  Because it's not possible to characterise a biologic to the same extent as a small molecule drug
• Can patients switch between an originator biologic and a biosimilar without consultation?

     - A. Yes, it's perfectly safe to switch between the two

     - B. No, any switch must be decided by the pharmacist

     - C. Yes, if the pharmacist deems it necessary

     - D. No, any switch must be decided by the prescriber following discussions with the patient

  No, any switch must be decided by the prescriber following discussions with the patient
• How are biosimilars prescribed?

     - A. By their generic name

     - B. By the same brand name as the originator biologic

     - C. By the brand name specific to the biosimilar

     - D. By the manufacturer's name

  By the brand name specific to the biosimilar
• What should be provided when reporting adverse drug reactions to biosimilars?

     - A. Only the patient's name

     - B. The brand name and batch number of the biosimilar

     - C. The prescriber's name

     - D. The patient's address

  The brand name and batch number of the biosimilar
• What type of medicines are expected to see increased use in the foreseeable future due to advances in biotechnology?

     - A. Synthetic medicines

     - B. Herbal medicines

     - C. Biological medicines

     - D. Chemical medicines

  Biological medicines
• Which of the following is an example of a biosimilar?

     - A. Aspirin

     - B. Paracetamol

     - C. Insulin glargine

     - D. Antibiotics

  Insulin glargine
• What is the term used for the original biologic on the market?

      - A. Innovator product

      - B. Originator product

      - C. First-gen biologic

      - D. Prime biologic

  Originator product
• Why are biosimilars introduced only after the expiration of patents and periods of marketing exclusivity?

      - A. To maintain high prices

      - B. To ensure patient safety

      - C. To encourage innovation

      - D. To facilitate market competition

  To facilitate market competition
• What is the primary reason biosimilars are not identical to the originator biologic?

      - A. Lack of demand

      - B. Inherent heterogeneity

      - C. Lower efficacy

      - D. Faster production process

  Inherent heterogeneity
• Who should make the decision to switch between an originator biologic and a biosimilar?

      - A. Pharmacist

      - B. Patient

      - C. Prescriber

      - D. Nurse

  Prescriber
• Why is it recommended to prescribe biologics by brand name rather than by their generic name?

      - A. To confuse patients

      - B. To prevent automatic substitution

      - C. To increase costs

      - D. To simplify prescriptions

  To prevent automatic substitution
• What should pharmacists confirm when dispensing a biologic to a patient?

      - A. The patient's address

      - B. The patient's age

      - C. The patient's expected outcome

      - D. The biologic the patient expects

  The biologic the patient expects
• How should adverse drug reactions to biosimilars be reported to facilitate effective safety monitoring?

      - A. Only report to the manufacturer

      - B. Provide only the patient's name

      - C. Provide the brand name and batch number

      - D. Don't report, it's unnecessary

  Provide the brand name and batch number
• What is the key factor in determining the efficacy of biosimilars?

      - A. Price

      - B. Brand name

      - C. Quality

      - D. Chemical composition

  Chemical composition
• Which regulatory authority recommends that biologics be prescribed by brand?

      - A. FDA (Food and Drug Administration)

      - B. EMA (European Medicines Agency)

      - C. MHRA (Medicines and Healthcare products Regulatory Agency)

      - D. WHO (World Health Organisation)

  MHRA (Medicines and Healthcare products Regulatory Agency)
• What action should pharmacists take to support patient safety regarding biosimilars?

      - A. Record only the patient's name

      - B. Record the brand name and batch number of the supplied biologic

      - C. Change the biologic brand without notifying the patient

      - D. Do not record any information

  Record the brand name and batch number of the supplied biologic
• What is the main reason behind the increased availability of biosimilars?

  1. Greater efficacy
  2. Lower production costs
  3. Faster regulatory approval
  4. Expiration of patents and marketing exclusivity

  Expiration of patents and marketing exclusivity