Aspen Generics

What is a generic medicine?
A generic medicine contains the same active ingredients as the innovator medicine, identical in strength or concentration, dosage form and route of administration, and meets the same or comparable standards complying with the requirements of therapeutic equivalence2

What is therapeutic equivalence?3
Medicines are considered to be therapeutic equivalents if they are both pharmaceutical equivalents and are bioequivalent.

What is pharmaceutical equivalence? 4
Medicinal products are considered pharmaceutical equivalents if they contain the same amount of active ingredient(s) in the same dosage form, meet the same or comparable standards and are intended to be administered by the same route.

What is bioequivalence?5
Bioequivalence compares the total amount of a particular medicine that is absorbed intact into the systemic circulation from a test and a recognised standard dosage form. It determines whether the test and standard dosage form contain equal doses of the same medicine and are equivalent in terms of their rates and extent of absorption of the medicine (i.e. systemic availabilities). This application of the concept of bioavailability is called bioequivalence.

Why are generic medicines more affordable?
It takes years of research and development to manufacture and market innovator medicines. There are huge costs associated with this, and in return, the pharmaceutical manufacturer’s originator medicine is protected by a patent period of up to 20 years.6, 7

Once the patent expires, the medicine can be made by another pharmaceutical company at a lower cost because there is minimal research and development involved. 8

What standards do generic medicines have to meet? 2
Healthcare professionals and consumers can be assured that Aspen’s high quality, effective and affordable generic medicines meet the same rigid standards as innovator medicines. In order to be registered by the MCC*, a generic medicine must:
• Contain the same active ingredients as the innovator medicine (inactive ingredients may vary)
• Be identical in strength, dosage form and route of administration
• Have the same indications for use
• Be bioequivalent**
• Be manufactured under the same strict standard for Good Manufacturing Practice Generic medicines: 6
• Have the same safety and efficacy as the innovator medicine
• Are of good quality
• Are subject to the same strict controls as originator medicines
• Are good value for money, as research and development costs are lower
• Are sometimes made by the same company as the originator medicine

A generic medicine may differ from the innovator only in:9
• Shape, colour or flavour
• Inactive ingredients
• Packaging and pack size
• Cost

Are different compositions possible?
Yes. Differences in composition between the generic and innovator are possible, but these differences do not influence the efficacy and safety of the medicine. The colouring agent, filler or the flavouring may differ but the medicine will contain the same amount of active ingredient.9

Who monitors the safety, quality and efficacy of generics?
All medicines, including generics, are registered by the MCC. The registration number appearing on the packaging confirms that the medicine has been thoroughly assessed for safety, quality and efficacy and that it can be used with peace of mind. 10

How does the MCC ensure that a generic medicine has the same safety, efficacy and quality as the innovator medicine?
All generic medicines undergo a rigorous, multistep review process that includes a review of scientific data on the generic medicine’s ingredients and performance. All manufacturing facilities are approved by the MCC, and periodic inspections of the manufacturing facilities are conducted according to regulations.2, 10

Myths and facts about generic medicines 2, 6, 9

MythFact
Generics are not as safe as innovator medicinesGenerics use the same active ingredients and
• work the same in the body
• have the same risk benefit profile as the innovator medicine
Generics are not as potent as innovator medicinesGeneric medicines have the same quality, strength, purity and stability as the innovator medicine
Generics take longer to act in the bodyGeneric medicines deliver the same amount of active ingredient in the same time as the innovator medicine
Innovator medicines are made in modern manufacturing facilities and generics are made in substandard facilitiesAll generic and innovator medicines are manufactured in tightly regulated facilities which comply with the strictest international manufacturing standards

Aspen’s commitment to quality
Aspen generic medicines are manufactured in facilities that comply with Good Manufacturing Practice and Aspen’s scientific knowledge and capability consistently ensure that each generic
produced strictly complies with standards of the MCC.11

What other products does Aspen manufacture?
Aspen is a JSE Ltd listed company, and is acknowledged as Africa’s largest pharmaceutical manufacturer. <sup11 In addition to generic medicines, Aspen also manufactures a diverse basket of branded, over-the-counter, consumer and infant nutritional products which are distributed to approximately 150 countries across the world.

Who can I speak to about Aspen generics and other medicines?
Your healthcare professional should be consulted exclusively should you have any queries regarding your medication and the possibility of switching to a generic. All adverse events should be reported to your healthcare professional.

When next you need medicine, make the choice that most South Africans make – choose an Aspen generic.

* MCC – Medicines Control Council
** for oral dosage forms

References:

  1. ImpactRx Data S3 and above, March 2013.
  2. Medicines and Related Substance Act, 1965 (Act 101 of 1965).
  3. Therapeutic Equivalence = Bioequivalence + Pharmaceutical Equivalence. Available at: http://bmctoday.net/vehiclesmatter/pdfs/TherapeuticEquivalence.pdf
  4. Department of Health: General Regulations (Act 101 of 1965).
  5. Proudfoot SG. Assessment of bioavailability. In: Aulton ME, editor. Pharmaceutics. The science of dosage form design. Churchill Livingston: 1988; p.191-211
  6. SAPC – South African Pharmacy Council. Available at: http://www.pharmcouncil.co.za
  7. WTO Intellectual Property (TRIPS) and Pharmaceuticals – Technical Note. Available at: http://www.wto.org
  8. SAPC -South African Pharmacy Council. Available at: http://www.pharmcouncil.co.za/D_phweek.asp
  9. Bumgärtel, C. Myths, questions, facts about generic drugs in the EU. Generics and Biosimilars Initiative Journal 2012;1(1):34-38.
  10. The History of Medicine Regulations in South Africa. Available at: http://www.mccza.com
  11. IMS TPM Feb 2014