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HOME >> MEDIA >> DRL seehs USFDA help to make cancer drug clone
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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 regulatorspharma 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.


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