Brand drug vs generic drug

generic vs branded a comparison for the benefit of the society

1. Generic vs Branded -A comparison for the benefit of the society Presented by SHUBHAM PAUL M.PHARM(PHARMACEUTICS) 2nd Semester NSHM KNOWLEDGE CAMPUS, KOLKATA GROUP OF INSTITUTIONS GUIDED BY:- Prof. Tapas Kumar Pal

2. Brand Name Drugs These drugs are also called as Innovator Drugs invented by Pharmaceutical companies to prevent them from being copied or reverse engineered by other companies. Generic Drug A generic drug is defined as “A drug product that is comparable to brand/innovator drug in dosage from, strength, route of administration, quality and performance characteristics and intended use”. It should contain the same active ingredients as the original formulation. According to the FDA, generic drugs are identical or within an acceptable bioequivalent range to the brand-name counterpart with respect to pharmacokinetics and pharmacodynamic properties.

3. Some Example of Generic and Branded Drug with their Price Category Generic Drug Price Branded Drug Price Analgesic Paracetamol Rs 2.45 Crocin Rs 11 Diclofenacsodium + Paracetamol Rs 4.4 Diclogesic Rs 19.40 Antibiotic Amoxyclin Rs 13.2 LMX Rs 40 Remox Rs 38.7 Azithromycin Rs 41.8 Azee Rs 107 Azithral Rs 128.55 Vitamin Folic acid Rs 2.8 Folivite Rs 11.8 B-Complex Rs 1.8 Becosul Rs 11.0 Cardiovascular(Blood Pressure) Drug Atenolol Rs 7.0 Aten Rs 23.8

4. Modern Trends for Shifting Pharmaceutical Market from Branded Drug to Generic Drug In 2010 India’s share of the generic market is about 30% out of 71.2% and reached $100 billion. In late 2012 40% of DMF’s were filled by Indian market in USFDA for supplying API’s. Now India’s share of the generic market is about to 35%. Hence the contribution of the Indian pharmaceutical industry for the growth of generic drugs in the world is very high.

5. Comparison between Generic and Brand Name Drugs Similarities Dissimilarities They must contain the same active ingredients. They must have the same dosage strength (example, 20mg or 40mg). They must be the same dosage form. They must have the same route of administration. They must deliver similar amounts of drug to the bloodstream. They could have different sizes, shapes, colors. They might have different inactive ingredients. The generic costs less than the brand name drug.

6. Why do Brand Name Drugs Cost more than Generics? Brand name drugs take several years, costly scientific development and many clinical studies to get Market approval. Manufacturers of brand name/Innovator drugs usually take on the research and development cost for new medications. These research and development costs, along with marketing costs, account for most of the higher prices pay for most brand name drug. In contrast, generic drugs have less research and development costs since the original manufacturer has already done many studies to make sure the drug is safe. These savings are passed on to the customer.

7. Bioavailability and Bioequivalence A generic drug is considered to be bioequivalent to the brand name drug in case: Similarities of three main parameters to establish bioequivalence. AUC: a rea under the concentration-time curve. Measure of the extent of bioavailability. Cmax : the observed maximum concentration of degree of absorption. tmax : the time after administration of drug at which Cmax is observed.

8. Contd …… AUC Ratio: The 90% confidence interval for this measure of relative bioavailability should be within a bioequivalence range of 80-125%. Cmax ratio: For maximal concentration data, the acceptance limit of 80-125% should be applied to the 90% confidence interval for the mean Cmax ratio. t max difference: Statistical evaluation of tmax makes sense only if there is a clinically relevant claim for rigid onset of action or concerns about adverse effects.

9. ANDA An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's Centre for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Generic applicants must scientifically demonstrate that their product is bioequivalent to the Innovator drug. Scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy volunteers. This gives them the rate of absorption, or bioavailability, of the generic drug, which they can then compare to that of the innovator drug. The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the innovator drug.

10. Similar FDA Requirements for Brand-Name and Generic Drugs FDA Requirements Brand Drug Generic Drug For reformulations of a brand-name drug or generic versions of a drug, FDA reviews data showing the drug is bioequivalent to the one used in the original safety and efficacy testing. √ √ FDA evaluates the manufacturer's adherence to good manufacturing practices before the drug is marketed. √ √ FDA reviews the active and inactive ingredients used in the formulation before the drug is marketed. √ √ FDA reviews the actual drug product. √ √ FDA reviews the drug's labeling. √ √

11. Contd ….. FDA Requirements Brand Drug Generic Drug Manufacturer must seek FDA approval before making major manufacturing changes or reformulating the drug. √ √ Manufacturer must report adverse reactions and serious adverse health effects to the FDA. √ √ FDA periodically inspects manufacturing plants. √ √ FDA monitors drug quality after approval. √ √

12. Hatch Waxman Act The act which surrounds the generic drug approval process of the USFDA is the “Hatch Waxman Act of 1984” which we also identify by the “ D rug price control and Patent Term Restoration Act of 1984” which led to a plethora of generic drugs entering into the market. Objectives of the act: Reducing the cost associated with the approval of a generic drug Allowing Early-Experimental-Use Compensating the branded drugs manufacturers for the time lost from the patent term because of the regulatory approval formality Motivating the generic drug manufacturers

13. ORANGE BOOK Orange book is a publication by the FDA approved drug products with therapeutic equivalence (TE) evaluation codes . Commonly known as the Orange Book due to the Orange cover of the original print version. It identified drug products on the basis of safety & effectiveness approval by FDA under FFD & C Act. Therapeutic equivalence evaluation codes have also been mentioned to provide public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of drug product selection and to foster containment of healthcare costs. The first edition appeared in October, 1980. The current (2011) Orange Book is the 31 st Edition.

14. Recent Rules by FDA for Generic Drug for India Generic drug manufacturers would be able to independently update product labelling (also called prescribing information or package inserts) with newly-acquired safety information before the FDA’s review of the change, in the same way brand drug manufacturers do today. Generic manufacturers would also be required to inform the brand name manufacturer about the change. All generic drug makers (like Ranbaxy Laboratories, Cipla , Dr Reddy's Laboratories, Lupin ) are now required to pay a fee to the US drug regulator while seeking permission to launch their products in the world's largest drug market. The recently enacted Generic Drug User Fee Act (GDUFA) legislation adds a $20,000-$30,000 fee at the first time the DMF is referenced in an ANDA. However, the high rates are likely to affect the number of DMFs filed in the coming years from India and around the world.

15. DRAWBACKS of Generic Medicine There may be some variations during reformulations. Some patients may be allergic to new colour , flavour etc. Generic drugs are not possible in all the cases. Because it takes long time to expire any patent. During bioequivalence studies, some error may arise which may lead to some complications. More over bioequivalence studies are less accurate than bioavailability studies.

16. Government role To promote cheap drugs in 2008, the govt. had set up a scheme called “Jan Ausadhi ” whose purpose was to set up Generic Drugs across the Country. The initial plan was to set up 3000 store across the country but 3 years later only 300 exists. But this scheme fails due to lack of awareness and incentives involved from pharma companies to doctors. Recently, Medical Council of India (MCI) release a circular issued to medical colleges, state medical councils and state governments about prescribing generic drug to patients.

17. Conclusion Generic drug are the answer to better healthcare for all. India has one of the highest out-of –pocket healthcare expenditure in the world and despite providing very cheap services (compared to rates of the countries like USA and UK) it’s still inaccessible to many due to poor purchasing power. The only way to promote generic drugs is to curb illicit medical practices and moreover the MCI needs to provide more practical guidelines rather than an archaic set of rubs which simply can’t be followed in the real world.

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