Drug regulatory authorities
Before a generic drug can be sold it must be approved by a regulatory pharmaceutical authority. These regulatory authorities include:
- US Food and Drug Administration (FDA)
- Medicines and Healthcare products Regulatory Agency (MHRA) in the UK
- European Medicines Agency (EMA also known as the EMEA)
- Medsafe, the New Zealand Medicines and Medical Devices Safety Authority
Manufacturers of generics must demonstrate to the regulatory authority that the generic product is bioequivalent to the brand product and meets the same strict regulations for safety and quality including strength, purity and stability. Also the generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs.
However, a generic drug will also have the same risks and benefits, which includes adverse effects or side effects. Any side effects that are associated with the brand name drug will also be associated with the generic drug.
Approval of generics
Approval of a generic drug by a regulatory pharmaceutical authority depends on the generic drug meeting the same rigid standards as the innovator drug. It must:
- contain the same active ingredients as the innovator drug
- be identical in strength, dosage form, and route of administration
- have the same indications for clinical use
- be bioequivalent
- meet the same batch requirements for identity, strength, purity, and quality
- be manufactured under the same strict standards required for innovator products
Bioequivalence
Bioequivalence ensures that a generic drug has the same active ingredients with the same effect on the body (pharmacodynamics) and the same absorption, distribution and elimination from the body (pharmacokinetics) as the brand drug. Therefore the generic version of a drug must be bioequivalent to the original brand name drug (originator or reference drug) produced by the company that invented and developed the drug (innovator company) in terms of dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.
There are specific criteria for bioequivalence that must be demonstrated before the generic drug van be approved and sold. These are:
- Dose: how much of the drug is take over a given time period, for example, 2 tablets per day.
- Strength: the amount of active ingredient per dose of the drug, for example 10mg.
- Route of administration: how the drug is taken into the body, for example, orally as a tablet or capsule; into the lungs by inhalation; directly into the blood or muscle by injection; as a suppository; transdermally (through the skin) as a patch.
- Safety: the safety profile of a drug, including side effects, precautions and contraindications.
- Efficacy: the clinical effect at the same dose, strength and using the same administration route over the same period of time.
- Intended use: what the drug should be used for and the clinical conditions it should be used to treat.
Active ingredients and excipients
A generic drug has exactly the same active ingredients and must have the same pharmacological and biological effect as the brand drug. The active ingredient of a pharmaceutical product is mixed with excipients, which are any other ingredients in the formulation of a drug that ensure that the active ingredient is able to be get to the right part of the body for it to have the desired effect. These excipients are generally different in the formulation of a generic drug and also there may also be differences in colour, flavour and shape. However, these differences between the generic and brand product must not affect the way the generic drug works.
Price difference between generics and brand drugs
The cost of bringing a new drug to market includes the development phase, the extensive fundamental and clinical research that can take many years, and the marketing. These costs are reflected in the price of a new drug and the innovator company is in a position to determine the cost of the drug without any competition.
While the patent is active, no other manufacturer can legally produce or sell the same drug. This is why the cost of the original brand product is higher than the generic product, as the generic manufacturer is not required to repeat the testing and clinical trials required for the originator drug. Also by the time a drug is off-patent, it is usually a well-established, frequently used medication and does not need extensive and costly advertising. The pharmaceutical companies producing generics can be the same company that makes the brand name product or it can be a different company. Also, more than one manufacturer can produce the same generic drug and this introduces market competition which also keeps the cost of generics down.
Since generics drugs are much cheaper than their equivalent branded product they are available to the consumer at a much reduced cost, making them more accessible.
Summary of generic product categories
- AIDS – containing medications that work by different mechanisms targeting the various viral enzymes required for replication of the Human Immunodeficiency Virus (HIV), which is an RNA virus causing acquired immune deficiency syndrome (AIDS), to prevent the replication and spread of HIV.
- Antidepressants – containing various classes of antidepressant medication that work by different mechanisms to interact with brain neurotransmitters, to improve nerve pathways that control mood and relieve symptoms of depression and related disorders.
- Cholesterol Lowing - containing medications used to treat high cholesterol (hypercholesterolaemia) by lowering cholesterol levels by various mechanisms, to reduce risk of cardiovascular disease.
- Diabetes - containing medications used to lower high blood sugar (hyperglycaemia) in type 2 diabetes mellitus, working by various different mechanisms to reduce risk of complications of diabetes.
- Heart Meds - containing various classes of medications used to treat cardiovascular conditions that compromise heart health, like high blood pressure, angina and congestive heart failure, to reduce risk of heart attack and stroke. Several drugs working by different mechanisms can be used to treat the same condition.
- Infections - containing medications used to treat infection due to bacteria, viruses and fungi; also infection caused by single cell parasitic organisms as in malaria or other parasites like the intestinal tapeworm.
- Mens Health - containing medications used to treat a range of men’s health issues, including prostate cancer, Benign Prostatic Hyperplasia (BPH), erectile dysfunction and hair loss due to male pattern baldness.
- Neurological - containing medications used to treat a range of neurological conditions such as epilepsy, migraine and Parkinson’s Disease, that work within the central nervous system to relieve symptoms including pain and seizures.
- Joint and Bone- containing medications used to treat conditions affecting bone and joints, like osteoporosis, arthritis and gout, to relieve symptoms including pain, inflammation and increased risk of fracture due to loss of bone density.
- Pain - containing medications used to treat a range of disorders to relieve symptoms including pain associated with these disorders, such as gout, arthritis, migraine, muscle spasm and nerve pain.
- Skin Care - containing oral and topical medications used to treat a range of skin conditions, including dermatitis, eczema, psoriasis; also viral, fungal and bacterial skin infections. This section also contains a skin lightening product for treating vitiligo.
- Stop smoking – containing an anti-addictive medication to use as part of a smoking cessation programme.
- Others – containing a range of medications to treat conditions including asthma, glaucoma, women’s health, breasts cancer, gastric reflux, hyperthyroidism (overactive thyroid).