Lines of Operation

Generic Drug Lifecycle

Developing Generic Drugs - How Does It work?

Teva aspires to be the first to market high quality, affordable, generic drugs

Teva is a leading global generic pharmaceutical company and has one of the broadest product pipelines in the industry.

 

Our generic medicines activities include:

  • 73 pharmaceutical and API production facilities
  • Approximately 149 product applications awaiting final FDA approval
  • Approximately 62 first to file applications pending in the US
  • 1,103 generic approvals in Europe, as of December 2012
  • Over 2,131 marketing authorization applications pending approval in 30 European countries.

Teva aspires to be the first to market high quality, affordable, generic medicines. How do we do it?

Selection and Preparation

Generic drugs are an equivalent therapeutic alternative to innovative drugs. They are typically sold at a substantially lower price, as their development process is relatively brief and less costly.
Generic drugs contain the same active ingredient as found in the innovative drug, and meet similar regulatory requirements as the innovative drug.
Reliance on generic drugs continues to grow due to the need to control healthcare costs, particularly given the increasing elderly population.

 

Teva constantly seeks to expand its generic portfolio, while concentrating on being first to introduce high-quality, affordable generic products into the market. When considering whether to develop a generic medicine, Teva takes into account R&D recommendations, manufacturing capabilities, regulatory and IP restrictions and commercial factors.

Generic R&D

Teva has the largest generic R&D team in the industry, committed to providing high quality generic drugs by:

  • Supporting local needs and regulatory requirements, while leveraging Teva's global presence, know-how and expertise
  • Utilizing vertical integration as a strategic advantage, gaining early access to API
  • Having a good understanding of the intellectual property landscape
  • Enjoying technological supremacy, possessing capabilities in a wide range of dosage forms (solid dose, injectables, ophthalmic solutions, nasal and optic drops, creams and ointments) and therapeutic areas
  • Developing specialized product families, such as hormones, narcotics, high-potency drugs and cytotoxic substances

Bioequivalence

A generic drug should be therapeutically equivalent to its reference innovative drug. The therapeutic equivalence is determined according to two parameters:

  1. Pharmaceutical equivalence
  2. Similar clinical effects and safety profile (when administered to patients according to approved indications)

To establish pharmaceutical equivalence, a generic drug should meet the following criteria:

  1. Contain the same active ingredient as the reference innovative drug
  2. Come in the same dosage form and mode of administration as the reference innovative drug
  3. Meet the same standards of strength, quality, purity and identity as the reference innovative drug

To ensure therapeutic equivalence, bioequivalence studies in humans are conducted. The bioequivalence study compares the bioavailability of the generic drug to the bioavailability of the reference innovative drug, in terms of rate and extent of absorption throughout the gastrointestinal (GI) tract. A similar rate and extent of absorption indicate that both medicines have a matching therapeutic effect and equal safety and efficacy profiles.

 

More about drug safety

Regulatory Affairs

Before a drug can be sold, it is necessary to obtain a marketing authorization from the relevant regulator. This stamp of approval confirms that that the drug is of high quality, and is safe and effective. To obtain a marketing authorization, companies submit an application demonstrating that the drug consistently complies with legal and regulatory requirements and that any label claims are supported by robust scientific evidence.


The regulators' evaluation of the report is undertaken by a skilled team of exsperts, including physicians, pharmacists and other scientists. In this way, healthcare professionals and patients can be confident that any drug sold, prescribed or administered as a generic, is a therapeutic equivalence of the original drug and is of the highest quality.


To obtain a marketing authorization for a generic drug, it is necessary to demonstrate that it provides the same quality, efficacy and safety as the reference innovative drug. The application includes information on the composition of the drug and a detailed description of how the active pharmaceutical ingredient and drug product are manufactured and controlled. This ensures that every batch is consistently manufactured to the required quality and is stable when stored at the recommended conditions.


 

In addition, there is a detailed description of the drug's development, including pharmaceutical, pre-clinical and clinical trials, to ensure that the drug is safe and efficacious. This often involves conducting studies with healthy volunteers, to demonstrate that the generic drug’s rate and extent of biological activity are the same as those of the innovative reference drug.

Obtaining a marketing authorization is, however, only the beginning of the process. Further obligations need to be fulfilled throughout the lifecycle of the drug, namely, monitoring the safety of the drug after launch.

Production and Distribution

Production commences in accordance with GMP regulations, to ensure the highest standards of quality.

 

Once production is completed, products are distributed to Teva's customers around the world: pharmacies and pharmacy chains, hospitals, health-insurers, wholesalers and more. Teva's vast supply chain succeeds, time and again, in meeting the most challenging deadlines, delivering the product by land, sea or air.

 

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