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Drugs and drug safety

What are innovative drugs?

Innovative drugs are also known as Originator, Reference or Brand.
Innovative drugs:

  • have gone through three or more phases of rigorous clinical trials over almost two decades
  • are authorised by officially established regulatory agencies (EMA, FDA) to be marketed and used by healthcare professionals on humans

Innovative or originator drugs are much more expensive than generic drugs because the pharmaceutical companies that produce them make considerable investments in carrying out clinical trials, which are required in order to test the safety and efficacy of innovative/reference drugs before they enter the market and provided to humans.

 

*Clinical trials are studies that aim to investigate the therapeutic effect(s) of medicinal products that have not yet been authorized by regulatory bodies such as the European Medicines Agency (EMA), or the value of authorized drugs in cases other than those for which it has been authorized. In addition, clinical trials are considered those studies that seek to assign specific products to a therapeutic strategy or propose to investigate effective diagnostic or monitoring procedures.

Read EU Directive 2001/20/EC 

 

What are Generic drugs?

Generic drugs are similar to Innovative/Originator/Reference drugs in the sense that they contain the same quantity of the same active substances and is administered via the same route (e.g., by mouth or by injection) and at the same dose as the innovative/reference drugs.

However, generic drugs are not required to undergo the same rigorous clinical trials as the innovative or originator drugs. They are authorised to enter the market by regulatory agencies over submitting an Abbreviated New Drug Application (ANDA). Through this route, it is mainly their active ingredients, and only some of their excipients* that are reviewed and tested for their safety and efficacy profiles before the overall generic drug receives approval to enter the market.

Usually, generic drugs only undergo what is referred to as “bio-equivalence” testing to assess whether the properties of the innovative/originator drug and the generic drugs are equally efficient for humans.

A drug can be referred to as generic only if it is manufactured as described above and only after the patency protection** and the data exclusivity of the originator drug have expired.

 

* excipients are the other chemical ingredients that are used to bind with the ‘active’ ingredient to complete the chemical formulation of the drug

**Patency protection: the period in which the drug is protected by a patent i.e., exclusive right granted to the pharmaceutical company for the protection of a drug that provides new ways of treating a disease/condition or offers new solution to treatment.

 

What are copy drugs?

Copy drugs are manufactured by copying the innovative/reference/originator drug, violating international patency laws. Copy drugs can be of very good quality and effective for patients, but they can also be of poor quality and ineffective, and consequently carry concerns and risks.

Copy drugs may:

  1. only have violated patency* rules and be of good quality

Or

  1. not have followed Good Manufacturing Practice (GMP)** rules and quality controls that are necessary in order to ensure the efficacy of the drug. In this case, a copy drug is a substandard drugs

* Patency laws are special rights granted to the pharmaceutical company that invented the drug.

** Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
Read more

 

What are counterfeit drugs?

A counterfeit or falsified drug is one that carries a deliberately and fraudulently mislabelled identity and/or source. Both branded and generic products can be counterfeit, and may include products with:

  • correct or wrong ingredients
  • insufficient (inadequate quantities of) active ingredient(s) or
  • fake packaging
  • no active ingredients
Read TIF position paper on counterfeit drugs

 

What are substandard drugs?

Substandard drugs are drugs which use has been authorised in a country but its manufacturing has not followed the quality and safety protocols, and recommendations of official national, regional or international drug regulatory authorities. Therefore, the safety and effectiveness of substandard drugs are greatly questioned.

A substandard drug may:

  • contain too much or too little of the active ingredient
  • be contaminated, poorly packaged or fail to meet quality standards in other ways
  • be a generic or a copy drug that has not followed quality standards and can thus have associated risks and consequences

 

What are biological drugs?

Biological drugs are made only from biological components i.e., substances that already exist in the human body e.g., insulin for diabetes.

Biological drugs undergo rigorous testing and multiple phases of clinical trials before they receive approval to enter the market.

 

What are biosimilar drugs?

Biosimilar drugs are manufactured on the basis of biological drugs and using the information from clinical trials that biological products have previously undergone.

After the patency period* of the biological medications has expired, pharmaceutical companies can use the information and data from these biological products to manufacture drugs of similar clinical effect.

 

**Patency protection: the period in which the drug is protected by a patent i.e., exclusive right granted to the pharmaceutical company for the protection of a drug that provides new ways of treating a disease/condition or offers new solution to treatment.