DRUGS

Question 1

What are biosimilar drugs? And how are they different to generics?

Answer 1

Generic drugs contain identical medicinal ingredient to their reference product, composed of small molecules drugs that are chemically synthesized.

biosimilar drugs are “highly similar to their reference biologics but close enough in to accomplish the same therapeutic and clinical result.

Question 2

Explain what a generic drug is and also the similarities and differences between a generic and a brand name drug.

Answer 2

Similarities of generic and brand:
1) Contain same active ingredient
2) Same dosage strength
3) Same dosage form
4) Same route of administration
5) Deliver similar bioequivalence /bioavailability

Difference of generic and brand:
1) Size, shape, colour, markings
2) Name
3) Inactive ingredient , as some people are sensitive.
4) Generic cost less
5) Generic varies by manufacturer :
- Different pharmacies carry different generics
- Same pharmacy may change generic due to change in suppliers.

Question 3

What does regulatory says about generics

Answer 3

Pharmaceutical legislation states test must be carried out on the generic medicine to demonstrate that it is comparable to the reference medicine to receive marketing authorisation.
Patent protection – Pharmaceutical company that hold this is the only one allowed to manufacture and market the drug and profit from it. Once patent expires other companies can manufacture, sell the drug and profit from it. They are now referred to as generic drug.

• Risk- benefit balance to be favourable
• positive therapeutic effects i
• Assessment on the result of scientific test/studies

Question 4

How can medicines be classified? Explain.

Answer 4

OTC :
- Purchase without a prescription
- Safe and effective when following directions on the label and by healthcare professional.
- A generic/cheaper version if check label/ingredients
Rx (prescription)
- Doctor will identify best medication for the illness and provide a prescription medication.
- May be Stronger than OTC
- Labels states any side effects that will occur or occurred under certain circumstances.
Biologics:
- Biologics/ biopharmaceutical Large protein molecule – composed of lots of amino acid.
- Copies/optimized version of endogenous human proteins.
- Produced by biotechnology process via genetically modified cells of microorganisms.
- Administered by injection/infusion to avoid exposure to the gastrointestinal tract where the environment is harsh in order to retain it structure to maintain its functionality because if not it will be ineffective.
Small molecule
- Processed into easily ingestible tablets/capsules by synthesis of chemical reactions between different organic/inorganic compounds.
When dissolved in gastrointestinal tract, the active substance is absorbed into the bloodstream via the intestinal wall. From there it can reach almost any desired destination in the body because of it low molecular weight