R&D
EU drug approvals roundup
It’s not just innovative new drugs and vaccines that go through the EU’s centralised procedure
nowadays – in 2008, a number of generics and biosimilars were approved for marketing,
and the fi rst OTC switch of a centrally approved medicine is on the way too
I
n the year from November 2007 to October • fluticasone furoate from GlaxoSmithKline for
forthcoming approvals
2008, some 28 new chemical entities, allergic rhinitis;
A number of products received positive opinions
combinations and vaccines were approved via • tadalafil from Lilly for erectile dysfunction; and
from the CHMP in September and October and
the EU’s centralised procedure. The products • olanzapine Mylan from Generics (UK) for
could be authorised for marketing by the end of
were for diseases ranging from cancer through schizophrenia.
2008.
cardiovascular diseases to diabetes and pandemic
Also approved was Extavia, an interferon beta-
flu.
1b product for multiple sclerosis from Novartis
They include:
As well as new substances, the European
Europharm. This is identical to Bayer Schering • Celgene’s Vidaza (azacitidine) for
Commission approved a number of generic
Pharma’s Betaferon/Betaseron and was approved myelodysplastic syndromes (this was the
products, four biosimilar medicines and a new
as an informed consent application authorised by 50th orphan drug to be given a positive
indication for thalidomide.
the originator. opinion);
2008 also marked a new stage in the
A product containing thalidomide from • Howmedica’s Opgenra (recombinant
development of the self-medication sector when
Pharmion (now part of Celgene) was registered
human osteogenic protein-1/eptotermin
the European Medicines Agency’s scientific
for the treatment of multiple myeloma, in
alfa) for posterolateral lumbar spinal fusion;
committee, the CHMP, recommended the first
combination with melphalan and prednisone.
• Merck KGaA’s Kuvan (sapropterin
switch from prescription-only to non-prescription
The biosimilar products approved during the
dihydrochloride) for
status for a centrally authorised medicine.
12-month period were Stada’s Silapo and
hyperphenylalaninaemia;
Among the generic medicines approved during
Hospira’s Retacrit (both epoetin zeta) for anaemia;
• Lilly’s Zypadhera (olanzapine pamoate) for
the 12-month period were the following
and the first biosimilar G-CSF products – Teva’s
the maintenance treatment of adult
(including some submitted by the originator
TevaGrastim and ratiopharm’s Ratiograstim, for
schizophrenia; and
companies):
chemotherapy induced neutropenia. The reference
• Alcon’s Azarga (brinzolamide/timolol) for
• olanzapine from Teva and Neopharma for
product for the G-CSF biosimilars was Amgen’s
decreasing intraocular pressure in glaucoma
schizophrenia;
Neupogen.
or ocular hypertension.
• clopidogrel from Sanofi Pharma-Bristol-
The OTC switch of a centrally authorised
Myers Squibb and BMS Pharma for the medicine was GSK’s anti-obesity medicine, Alli
Ian Schofi eld is a principal
analyst for Informa Pharma.
prevention of atherothrombotic events; (orlistat). It was approved as a lower-dose (60mg)
• duloxetine from Boehringer Ingelheim for capsule for use in conjunction with diet for the
stress urinary incontinence and diabetic treatment of patients with a body mass index of
peripheral neuropathic pain; 28 or above.
48
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