genglob magazine

Over the last few years generic medicines have become popular and helping people out of insurance cover to get advanced drugs cost effectively. But there has always been a confusion with what is actually generic medicine and some myths about their quality. The availability of generic medicines gives consumers greater choice in the  brand and price of their medicines. However, misconceptions remain about the interchangeability of different brands and the proliferation of brands has potential for confusion. This articles aims to dispel some of the myths and provide more details on what actually is generic medicines (also called generics).

The company that first develops a medicine takes out a patent to ensure its exclusive right to produce and market it. Once the patent expires, typically 10 years after the medicine is first marketed, others can copy and market the same active ingredient. These alternative brands are called generic medicines.

To register a new medicine for use, a company must demonstrate its safety and efficacy in clinical trials. To register a generic medicine, a company need not conduct extensive clinical trials if they show that their product achieves such similar blood concentrations of the drug that its efficacy and safety will be no different from the original product (i.e. it is bio-equivalent). The number of alternative brands for an off-patent medicine usually relates to the size and profitability of the market for that medicine.

Efficacy and safety

A generic medicine must be shown to be bio-equivalent to another registered brand to be interchangeable with that brand. Bio-equivalence is based on the principle that a medicine’s effects are related to its plasma concentration. The criteria for bioequivalence aim to exclude the possibility of clinically important differences between brands.

Quality

All medicines approved, including generic medicines, are required to meet the same quality criteria. Manufacturers especially the one following WHO/GMP guideline and approved by FDA must comply with the code of manufacturing to ensure that all medicines are safe reliable and of consistent high quality (All of the medicines supplied at our sponsor genglob.com are from GMP/WHO or FDA certified manufacturing facilities).

Name

Generic medicines may be marketed under their own brand name or their generic name. For example, Simvar, Simvastatin-DP and Terry White Chemists are all brands of Simavastin. Irressa, Geftinat are all brands of Gefitinib. Erlonat, Erlocip, Tarceva are all brands of erlotinib.

Manufacturer

Some companies specialise in producing generic medicines. However, originator companies may manufacture and market alternative brands of manufactured on the same production line will be marketed under two brand names and at two prices.  For example Abraxene is US is marketed by original manufacturer but is marketed in India by Biocon which has licensing agreement with the original innovator company. The drug in India is sold at 40% cheaper price then US. Although both medicine are produced on the same production line.

Ingredients

Inactive ingredients (or excipients, such as binders and fillers) may differ between bioequivalent products. Adverse reactions to excipients are extremely rare, so these differences will not usually be clinically significant. However, the presence of some excipients (such as gluten or animal-derived gelatin and stearic acid) may be important for people with allergies or who observe particular religious or cultural practices. Ingredients are listed at the end of the consumer medicine information (CMI) for each brand.

Appearance

Bioequivalent products may differ in colour, size, shape, taste and markings.

Packaging

Alternative brands may be packaged in different ways: for example, blister packs or bottles.

Price

A company may include a premium on the price of its brand, making it more expensive for consumers.