What Are Bioequivalent Generic Drugs? #pharmaceutical #contract #manufacturers


Posted On Nov 6 2017 by

#mylan pharma

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Mylan Worldwide

Why Generics?

At Mylan, we have one global quality standard in everything we do.

Because 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.

Want to know more about generic medicines? See the facts, figures and bioequivalence requirements below.

Percentage of U.S. prescriptions filled with a generic medicine

Number of U.S. prescriptions, brand name or generic, filled with a Mylan product

Food and Drug Administration: This agency must approve every generic medicine before it can be sold in the United States.

To gain FDA approval, generic medicines must be proven to be bioequivalent to their brand name counterparts. That means generic and brand name medicines are the same in the following ways:

  • Active ingredient
  • Maximum amount of medicine in the blood at any given time
  • Total amount of medicine in the blood from the time it s taken until the body eliminates it
  • Strength and dosage
  • Route of administration tablet, injection, etc.
  • Expected safety and efficacy
  • FDA evaluation of manufacturing facilities

Just because products have the same active ingredient does not mean they are bioequivalent. Once generic bioequivalence is proven, the FDA considers a generic medicine interchangeable with the brand name medicine.

Average amount consumers can save by filling a prescription with a generic rather than a brand name medicine. The price of generic medicines is usually lower, when compared to brand name medicines, since they are not invented from scratch, generally subject to clinical trials or supported by advertising campaigns

$1.2 Trillion! According to IMS Health, generic medications saved the U.S. health care system an estimated $1.2 trillion from 2003 to 2012.

Main factors behind the growth of the generics industry

  • Aging population
  • Desire to reduce health care spending

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.

Resources and information to help prescribe, dispense and take medicine with confidence.

Pharmacists

Educational materials to help empower your customers.


  • Patients

    What to know about our high quality generics.


  • Physicians

    Details about our brand name and generic medicines.


  • Health Systems Customers

    Resources that meet the specific needs of your institution.


  • Last Updated on: November 6th, 2017 at 3:15 am, by


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