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Why Generics?

At Mylan we have one global quality standard in everything we do. There is nothing generic about our standards. Our internal teams conduct reviews of all products, start to finish, no matter where in the world they are made.

Why such high standards? Because we truly care about the people who will be helped by the medicines we make. And we believe in earning that trust from physicians, pharmacists, other health care professionals and patients, every day. It’s why we say, “Our Mylan is Your Mylan.”

How do generic medicines become available?

When a pharmaceutical company develops a new original medicine, it takes out a patent. The new medicine usually has a unique name or brand. It can also be called an “originator” medicine. When a patent’s time period comes to an end, other pharmaceutical companies can make a similar version – a generic – of the original medicine. The generic versions can sometimes be substituted “interchangeable’” for the original medicines.

  • Drug Monitoring

    Over 60% Market Share

    Generic drugs made up over 60% of the total off-patent medicines market in Ireland by the end of 20141

  • Drug Standards

    HPRA and EMA

    In the European Union, all medicines, originator or generic, have to be authorised before they may be produced and distributed to patients. The Irish Health Products Regulatory Authority (HPRA) or European Medicines Agency (EMA) assess quality, safety and efficacy and approve every generic medicine before it can be placed on the market in Ireland

  • Counterfeit Drugs

    Bioequivalence

    To gain HPRA or EMA approval, generic medicines must be proven to be “bioequivalent” to their brand name medicines, complying with exactly the same standards of quality, safety and efficacy as all medicinal products. That means generic and brand name medicines are the same in the following ways:

    • Effect
    • Active ingredient
    • Safety and efficacy
    • Strength and dosage
    • Maximum amount of medicine in the blood at any given time
    • Total amount of medicine in the blood from the time it is taken until the body eliminates it
    • Route of administration – tablet, injection etc.
    • HPRA evaluation of manufacturing facilities
    Find out more about generic medicines from the Irish Health Products Regulatory Authority here: https://www.hpra.ie/docs/default-source/publications-forms/information-leaflets/generic-medicines_web.pdf?sfvrsn=4
  • Proof of Purity and Potency

    €23 Million

    Generic medicines saved the Irish health care system an estimated €23.3 million in 2014 over 2013

  • GMP Audit Promise

    There are two main factors behind the popularity of generics:

    • Frequent lower prices of generic medicines versus branded products, means consumers can generally better afford their medication, while still being sure of the same quality
    • When we use generic medicines, national health authorities across Europe save considerable sums of money – many billions of Euros. This frees up much needed financial resources to pay for other, more expensive treatments and services that patients need, including funding research into new treatments and medicines
  • USP Requirements

    Innovation

    Innovation is the key to Mylan’s ability to bring new Generics to market, especially medicines that are difficult-to-manufacture and difficult-to-formulate. Find out about our therapeutic innovation.

1Feargal Goodman, Assistant Sec. of the Primary Care Division, Dept. of Health speaking at the Joint Committee on Health and Children, regarding the Cost of Pharmaceutical drugs, 12th March, 2015
Last Updated  27/02/2015