The truth:
Six facts you need
to know about generic
medication

Generic medications undergo the same testing and are held to the same standards as their brand-name counterparts.

The reason for the price difference is that, once a patent has expired, generic drugs get to “piggyback” on scientific research and clinical trials that have already been done by their branded counterparts. Because Health Canada has already determined that the brand-name medicine is safe and effective, generic pharmaceutical companies simply have to show that their product is bioequivalent to the brand product, meaning that the same quantity of drug is circulating in the body for the same amount of time. Proving bioequivalence—which confirms that the generic medication has the same efficacy and safety—is much less expensive than the clinical trials.

Consider this, also: If a generic version of a medication is available, Canadian hospitals generally choose it as their first option. If the health professionals in hospitals didn’t think generic drugs were of high quality, they wouldn’t choose them.

Because generic medications contain the same active ingredient as the brand-name drug, side effects from the active ingredient will be the same.

Medications also contain non-active ingredients, which allow us to make a tablet or capsule that is homogeneous and delivers a correct and usable dosage of active ingredient. In many cases, we use the same non-active ingredients as the brand-name drug—often from the exact same supplier!

There are instances in which the non-active ingredients may differ slightly (although they must still meet rigorous testing and national standards). It is possible that some people are sensitive to this difference. All of our medications are accompanied by a patient-information leaflet. This leaflet provides information on non-active ingredients. If you have any questions, be sure to discuss them with your physician or pharmacist.

At Teva, we develop and manufacture brand-name and generic medications. This gives us a unique perspective, in that we see the value of each type of medication in our healthcare system.

We know that brand-name pharmaceuticals certainly play an important role in driving innovative new therapies, and we are proud to bring many of these innovative therapies to the patients who need them.

Once a generic version of an innovative (brand-name) product is available, there are many reasons to choose a generic medicine. One important consideration is that the savings to you, your drug plan or the healthcare system can be reinvested in bringing new medicines to Canadians.

Also, if a generic medication is available, it generally means that doctors and patients have had years, often 20 or more, to learn about the medication’s side effects, interactions and other aspects that may have been unforeseen when the brand-name version was first launched. Generic products are proven medications, with proven safety and efficacy. They are medications you can trust.

To be approved by Health Canada, generic medications must be pharmaceutically equivalent. This means that they:

• must contain the same amount of active ingredient as their branded counterparts; they cannot contain more or less
• must be the same dosage form
• must be the same strength
• must use the same route of administration
• must reach the same systemic concentration (be bioequivalent).

The misconception about the 80–125% (bioequivalent range) comes from the way brand-name drugs are approved in the first place, and from the fact that different people absorb medications differently. The 80–125% (or 90–112% for “critical-dose drugs,” or any other value) “effective range” is created by the brand for its product, to account for the allowable variability among different individuals—not to account for variability or potency in the medication itself. Brand-name companies also use the same bioequivalence concept and criteria to support changes in their own product—whether a change in formulation or a change in manufacturing sites, for example. This bioequivalence range becomes the standard for the brand-name medication and its subsequent generic alternatives. This measure is used by Health Canada as a trustworthy standard for designating products as “the same.”

Teva Canada manufactures both generic and brand-name pharmaceuticals. We know that, while brand-name pharmaceuticals certainly play an important role in driving innovative new therapies, generic equivalents are equally vital to our healthcare system, because they deliver significant cost savings and improve accessibility for all—to proven, trusted medications.

International laws recognize that a price monopoly should last for a limited time period. For medications in Canada, that time period is 20 years. Brand-name manufacturers price their products higher to recoup their research investment during this monopoly period.

Once the patent-protected monopoly is over, however, we bring generic versions of these drugs to market—allowing patients and Canadian taxpayers to benefit from the savings of billions of dollars each year.

In 2015 alone, generic drugs saved the Canadian healthcare system, employers and consumers nearly $15 billion—savings that can be reinvested in healthcare services.

Generic medications create competition for brand-name medications—healthy competition that improves accessibility to medication, saves money and stimulates innovation.

By asking for a generic medicine, you’ll pay, on average, 60% to 80% less for a product that you already know is different only in name and price. These cost savings do more than keep money in your pocket—they ensure that affordable medicine is accessible today, and they make room for the innovative medicines we will need in the future.

In 2015 alone in Canada, the use of lower-cost generic prescription medicines saved governments, employers and consumers nearly $15 billion.*

*Canadian Generic Pharmaceutical Association (CGPA).