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Industry News :
DRL seeks USFDA
help to make cancer drug clone
DR REDDYS Laboratories (DRL), Indias secondlargest drug maker by
sales, has approached the US Food and Drug Administration (USFDA)
to overcome impediments in making the generic version of Revlimid,
an expensive drug used to treat blood cancer.
US-based biotech firm Celgene, the innovator, has declined to make
the drug samples available to DRL for bio-equivalence studies.
Celgene has refused to provide DRL with the required quantities of
the drug, saying the company was under no obligation to supply
samples to DRL when the latter approached the former for Revlimid
supply.
According to the USFDA mandate, every generic maker has to conduct
bio-equivalence studies to prove that their formulation exhibits
the samev properties of the innovator product before getting the
FDAs nod. This drug is unavailable through normal distribution
channels, and hence, DRL is forced to buy it from Celgene.
Another obstacle that DRL has to reckon with is the US drug
regulators
holding back the approval to make a copycat version as the
regulator is conducting a risk evaluation and mitigation strategy
(REMS) on Revlimid. A REMS study is conducted by the USFDA when it
suspects that a medicines risks outweigh the benefits of the drug
or biological product. The regulator is carrying out this
examination as the Revlimid therapy is known to cause certain
birth defects in children if consumed by expectant mothers.
Dr Reddys alleged that Celgene is also stating the REMS study as
an alibi to prevent the Indian pharma major to manufacture a
generic version of the drug. DRL is facing a hurdle in the making
of Revlimid and Celgene has refused to provide us with the
samples. Celgene is using REMS as the reason why they are unable
to provide us with samples, the company confirmed in an e-mailed
response to ET. But the USFDA law states unequivocally that
restricted distribution programmes of drugs are not to be used to
block or delay generic competition . DRL has, therefore, appealed
to the US FDA, to spell out the policy on REMS. We have filed a
petition with the USFDA about Celgene using REMS restriction to
block our chances of making the drug. But the regulator has not
officially commented to us, the company said.
Revenues from DRLs global generic business for the quarter ended
June 2009 was Rs 1,300 crore, and the nod from the USFDA to make
and market this drug could bolster its revenues by a heavy margin,
given its tie-up with global pharma major GlaxoSmithKline (GSK).
Indian firms are growing more assertive in attacking patents
today. The growing popularity of generic medicines is leading
governments to look for cheaper alternatives. So, if Dr Reddys is
permitted to manufacture cheaper versions of Revlimid, it could
bite into Celgenes revenues significantly as the medicine is sold
in most parts of the world, said an analyst from KPMG tracking the
pharma sector. Generic drugs account for more than 60% of all
prescriptions in the US, and DRLs success could spell possible
trouble for Celgene. Revlimid is now sold in nearly 50 countries,
including the European nations, North and South America, the
Middle East and Asia.
Quality
holding back the approval to make a copycat version as the
regulator is conducting a risk evaluation and mitigation strategy
(REMS) on Revlimid. A REMS study is conducted by the USFDA when it
suspects that a medicines risks outweigh the benefits of the drug
or biological product. The regulator is carrying out this
examination as the Revlimid therapy is known to cause certain
birth defects in children if consumed by expectant mothers. 
