EMA’s mid-year report for 2012 has shown that the number of generics applications is much lower than the agency has predicted, while for biosimilars it is the opposite.
The report, which covers the period of January to June 2012, shows a significant decrease in the number of generics applications compared to the second quarter of 2011. In fact, during 2012 there have been so far only 11 generics applications compared to 21 during the same period in 2011.
In the same period of January to June 2012, the agency reports an increase in applications for biosimilars, see Table 1. In the first six months of 2012, EMA has already received six applications for ‘similar biological products’ or biosimilars compared to 0, 0 and 1 application during the same period in 2011, 2010 and 2009, respectively.
While the agency expects the number of generics applications to remain low, it does expect there will be an increase later in the year. EMA has, however, still revised its forecast down from a prediction of 32 generics applications to only 18 applications expected during 2012, see Table 1. Biosimilars on the other hand have already exceeded their forecast of five applications for the whole of 2012 in just the first six months. EMA has therefore revised its forecast for biosimilars to eight applications during 2012.
Table 1: Applications submitted to EMA
| Procedure
|
2012
(Q1-Q2)
(actual)
|
2012
(forecast)
|
2012
revised forecast
|
2011
(Q1-Q2)
|
2010
(Q1-Q2)
|
2009
(Q1-Q2)
|
| New non-orphan medicinal products
|
25
|
52
|
50
|
15
|
18
|
14
|
| New orphan medicinal products
|
8
|
13
|
17
|
8
|
6
|
4
|
| Biosimilars
|
6
|
5
|
8
|
0
|
0
|
1
|
| Generics
|
11
|
32
|
18
|
21
|
8
|
31
|
| Hybrid and abridged applications
|
2
|
7
|
5
|
4
|
2
|
1
|
| Scientific opinions for non-EU markets
|
0
|
1
|
1
|
0
|
1
|
0
|
| Paediatric-use marketing authorisations
|
0
|
0
|
0
|
1
|
0
|
0
|
| Advanced therapy re-registration
|
1
|
2
|
2
|
0
|
0
|
N/A
|
N/A = not applicable
It appears that the patent cliff and generics competition is not affecting the number of new drug applications. EMA has already received 25 applications for non-orphan drugs in the first six months of 2012 compared to only 15 during the same period in 2011.
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