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In order to extend the life cycle of their products and block competition in generic drugs, original (patented) drug companies can "modify"
existing drugs that have been approved for marketing through channels such as new formulations (such as new dosage forms, new compounds).
New formulations can often improve patient compliance and provide additional benefits
for disease treatment by increasing ease of administration, reducing dosing frequency, or improving tolerability.
However, in some cases, new formulations, particularly tablets and capsules, may not be clinically superior to the original new drug, and their potential convenience benefits may be offset
by their cost.
A well-planned product jump strategy
A well-planned product jump strategyThe concern is that the new formulation forms part of
the company's elaborate strategy for product lifecycle management.
Innovator drug companies use these strategies to extend market exclusivity and thus extend drug-related revenue
in the face of generic competition.
Studies have found that when the first generic drug is approved to enter the market, the original drug company usually develops a new formula in advance to block the competition of generic drugs
.
Innovator drug companies generally decide when to adopt a new formulation strategy
based on the degree of impact of generic drugs on the original new drug.
Strategically delaying the use of new formulations until generic drugs enter the market complicates
the ability of generic drugs to reach widespread use and reduce prescription drug spending.
For example, in a type called a product jump
Hopping), in which innovator drug companies may aggressively promote new formulations rather than first-approved new drugs, thereby preventing generic drugs from replacing new formulations
.
The product hopping strategy has led to significant excessive medical spending
due to the delayed availability of new formulations, as well as the entry to market of extended-release formulations and fixed-dose combination drugs of uncertain marginal value.
How the original drug company "orchestrates" new formulations
How the original drug company "orchestrates" new formulationsBy studying the time when the first new formula was approved and the time when the first generic drug was approved, the researchers can see how the original drug company develops new formulations
through product jumping strategies.
New molecular entities (new drugs) in 206 tablet and capsule dosage forms approved by the U.
S.
Food and Drug Administration (FDA)
between January 1, 1995 and December 31, 2010 were collected through the Drugs@FDA database.
As of December 31, 2021, of the 206 new drugs, 81 new drugs (39.
3%) had at least one new formulation re-approved by the FDA, and at least one generic drug had been approved by the FDA, and 167 (81.
1%) had new drugs approved; 65 new drugs (31.
6%) received FDA approval for at least one new formulation and one generic drug at the same time
.
Layout nearly 6 years ahead of schedule
Layout nearly 6 years ahead of scheduleAmong the 81 new drugs with FDA approval, 45 (21.
8%) of 1 new formulation were approved, 2 new formulations were approved for 23 (11.
2%) and 3 or more new formulations were approved
for 13 (6.
3%) new drugs.
Among them, nearly half of the first new formulations are new dosage forms (such as extended release dosage forms), 34 new drugs (41.
9%), the first batch of new formulations are compound drugs 29 (35.
8%) more than one-third, and the first new indications are 13 (16.
0%)
.
Among drugs with at least one new formulation approved, the median time (IQR) from the launch of the original new drug to the approval of the first new formulation was 4.
6 (2.
3-8.
6) years
.
Among drugs with at least 1 generic drug, the median time from original new drug to generic first approval was 11.
4 (8.
1-14.
5) years
.
For varieties with both new and generic drugs, the median time to first new formulation approval before the first generic approval is 5.
9 (1.
5-10.
9) years
.
High adoption rate of blockbuster and accelerated approved drugs
High adoption rate of blockbuster and accelerated approved drugsIn multivariate analysis, new formulations were significantly more likely to be used in blockbuster drugs (58.
2%) and new drugs with accelerated approval (50.
0%), and a smaller proportion (11.
8%)
in orphan drug products.
WHO Essential Medicines List, first-of-its-kind new medicines or superior to existing similar medicines, according to Prescrire, the French regulator of the pharmaceutical industry
International's rating has little to do
with the likelihood of an increased new formulation.
There was also no statistically significant difference in the likelihood of new formulations in different treatment areas
.
Compete with generics
Compete with genericsOf the 65 new drugs that had at least one new formulation and one generic at the same time, 55 (84.
6%) new formulations were approved before the first generic approval and 10 (15.
4%) were approved
after generic approval.
It can be seen that if the first new formula cannot be launched before the first generic drug product is approved, it is less
likely to be approved.
revelation
revelationOf the 206 new drugs in tablet or capsule form approved by the FDA from 1995 to 2010, more than one-third of new drugs were approved for at least one new formulation by 2021, with a significantly higher proportion of blockbuster and accelerated drug development new formulations approved for marketing, while other measures of therapeutic value (including innovative and clinical value) were independent
of the proportion of new formulation approved.
Because accelerated approved drugs are most commonly used to treat cancer, it is more likely that these drugs will again be developed to improve convenience or tolerability
for patients.
In addition, after the first generic drug was approved, the approval of new formulations decreased
dramatically.
These results suggest that market revenue is the primary driver for whether and when innovator companies launch the first new formulation of an existing drug that has received FDA approval, illustrating that the primary purpose of innovator drug companies in using extended product lifecycle management strategies is to maintain revenue and avoid generic competition
.
Analysis of the timing of new formulation approval shows that innovator drug developers strategically schedule it, especially relative to the first generic approval
.
Once the original patented drug market faces generic competition and is difficult to recover, the interest of original drug developers in developing new formulations may wane
.
Another study based on examining new formulations for new indications found that 32% of drugs received approval for new indications before the generic went on the market, but such approvals declined
thereafter.
The new formulation has important implications
for patient acquisition, clinical care, and healthcare funding.
Some new formulations may not have clear benefits for patient adherence, but can put financial pressure
on patients and healthcare systems.
