Transcript Are generic drugs as safe and effective as branded

BASICS IN PHARMA
Definition of 'Market Share'
The percentage of an industry or market's total
sales that is earned by a particular company
over a specified time period.
Market share is calculated by taking the
company's sales over the period and dividing
it by the total sales of the industry over the
same period. This metric is used to give a
general idea of the size of a company to its
market and its competitors.
Competitive Market
A market with a large number of buyers and sellers, such that no
single buyer or seller is able to influence the price or control any
other aspect of the market. That is, none of the participants
have significant market control. A competitive market achieves
efficiency in the allocation.
Efficiency is achieved because competition among buyers
forces buyers to pay their maximum demand price and
competition among sellers forces sellers to charge their
minimum supply price for the given quantity exchanged. of
scarce resources if no other market failures are present.
Branded and Generic Drugs
Branded Product - Pfizer
Generic Product - Watson
What are Generic Drugs
A generic drug is the bio-equivalent version of a brand name
drug.
Bio-equivalence, certified by the U.S. FDA, means a generic
drug has the same dosage form, safety, strength, route of
administration, quality, performance characteristics and
intended use as the branded version of the drug.
Although therapeutically equivalent to their branded
counterparts, generic drugs are typically sold at substantial
discounts from the branded price.
Why is there a difference in cost between
branded drugs and generic drugs ?
New drugs, like other new products, are typically developed with
patent protection.
The patent protects the investment a company makes in investing
in the drug's development by giving the company the right to
exclude others from selling the drug while the patent is in effect.
When patents expire, other manufacturers can make and sell the
FDA approved generic versions of the drug.
The ANDA process does not require the drug sponsor to repeat the
costly animal and clinical research on ingredients or dosage forms
already approved for safety and effectiveness.
Since generic manufacturers have plenty of competition, lower
R&D costs, and spend much less on advertising and marketing
efforts, their products are priced much lower than branded
counterparts.
Are generic drugs as safe and
effective as branded drugs?
The U.S. FDA regulates all generic products under strict guidelines,
requiring the same testing as the branded product to ensure that the
generic version is interchangeable with its branded counterpart.
For both brand name and generic drugs, the U.S. FDA works with
pharmaceutical companies to ensure that all drugs marketed in the
U.S. meet specifications for identity, strength, quality, purity and
potency.
In approving a generic drug, the U.S. FDA has tests and procedures to
ensure that the generic drug is interchangeable with the brand name
drug under all indications and conditions of use for which the
branded product is approved.
Do generics differ at all from brands?
Generics may differ slightly from brands in regards to inactive
ingredients.
The U.S. FDA allows generics to use different inactive ingredients,
from those used in the brand, as long as bioequivalence is attained.
Inactive ingredients, such as fillers and dyes, do not affect the
safety or performance of drugs or API.
Major therapies and molecules
Major Molecules and Diseases
Sr.No.
CAUSE OF DEATH
MALE
FEMALE
TOTAL
(Ages 25-69 as percentages)
1
Cardiovascular Disease
26.3
22.5
24.8
2
Respiratory Disease
10.1
10.4
10.2
3
Tuberculosis
11.4
8.3
10.1
4
Malignant and other tumours
7.8
11.8
9.4
5
ILL defined conditions
4.8
6.0
5.3
6
Digestive Systems
6.1
3.5
5.1
7
Diarrhoeal Diseases
4.0
6.6
5.0
8
Malaria
2.4
3.4
2.8
(All ages expressed as percentages)
Major Molecules and Diseases
Sr.No.
CAUSE OF DEATH
MALE
FEMALE
TOTAL
(All ages expressed as percentages)
1
Cardiovascular Disease
20.3
16.9
18.8
2
Respiratory Disease
9.3
8.0
8.7
3
Diarrhoeal Diseases
6.7
9.9
8.7
4
Prenatal Conditions
6.4
6.2
6.3
5
Respiratory Conditions
5.4
7.1
6.2
6
Tuberculosis
7.1
4.7
6.0
7
Malignant and other tumours
5.0
6.0
5.7
Indian pharmaceutical market ( IPM)
therapies by market share
6.3 6.0
6.6
ANTIINFECTIVE
CARDIAC
6.2
20.6
GASTRO
12.8
9.0
10.1
10.1
12.3
RESPIRATORY
PAIN &
ANALGESIC
VITAMINS/MI
NERALS
GYNAEC
THANK YOU
-PHARMA STREET