BackNatco drops Albupax launch despite overcoming patent, safety hurdles
While Natco has been unable to launch its biosimilar version of the breast cancer drug, three other firms have introduced theirs
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Mumbai: Natco Pharma Ltd has dropped plans to launch a biosimilar version of breast cancer drug Abraxane, after having successfully challenged the innovator’s patent and promised a generic copy at one-fifth the price.
The Hyderabad-based cancer drug maker, which had also won a dispute over quality in 2009, was to have launched its cheaper generic version in 2011.
“We haven’t launched the generic drug due to commercial reasons," said a Natco spokesperson in response to a Mint query last week.
The company first launched the drug in 2008, challenging a patent application filed by US biotechnology company Abraxis Bioscience Inc. in India.
That took place three months after Abraxis launched the drug in India through local partner Biocon Ltd.
Natco’s version, Albupax, was the first indigenously developed nanotech-based cancer drug.
It was recalled by the Drug Controller General of India (DCGI) in 2009 after an investigation of complaints filed by Biocon alleging serious safety violations.
The low-cost drug was expected to hit the market in early 2011 soon after the company got the health ministry’s approval to re-launch the product.
While Natco has been unable to do so, other local companies Cipla Ltd, Panacea Biotec Ltd and Fresenius Kabi Oncology India Ltd (formerly Dabur Pharma Ltd) have introduced their versions.
Biocon and Natco both projected a ₹ 150 crore market for breast cancer drugs in 2008. The disease is the second largest cancer-related cause of death among women in India, with at least 100,000 new cases every year. Abraxane costs around ₹ 30,000 per vial of 100 mg in India, which is about 50% less than its US price of $1010 (around ₹ 60,000) a dose.
However, with the offerings of various Indian rivals ranging between ₹ 11,000 and ₹ 15,000 a dose, there’s a lot of competition now.
“The market situation today is much different from earlier. Now there are three other generic players. The product has a heavy competition and there are huge discounts offered on maximum retail price (MRP) by each of the companies," the Natco spokesperson said in an email.
The science of developing biosimilars isn’t easy to convert into a manufacturing process, experts said.
“Biosimilar products are difficult to develop. Natco must have found it difficult to match the standards from the beginning, as the market competition is comparatively a new scenario and it was not the case initially," said an industry expert, who didn’t want to be identified.
In 2009, DCGI had recalled all batches of Albupax, along with an order suspending Natco’s manufacturing and marketing licences, following a complaint from Abraxis and Biocon that the generic drug contained toxic materials.
Prashant Reddy, an intellectual property lawyer who tracked the DCGI investigation on the Natco product using the right-to-information (RTI) route for academic interest, was surprised that the company had dropped its plan.
“Natco is usually a very aggressive company when it comes to new launches in the oncology segment and it is surprising that it has not launched a drug after the health minister over-ruled the DCGI’s decision to cancel Natco’s licence for Albupax," he said.
According to Reddy, the Central Drug Laboratory (CDL) addressed only one of the issues raised in the complaint—high endotoxin levels. CDL reported that Natco’s product failed two endotoxin tests before passing in the third round of testing in January 2011. DCGI and the health ministry thereafter decided to not prosecute Natco under the Drugs and Cosmetics Act, he said.
A Natco spokesperson said: “There are no regulatory issues now."
“However, from the papers given to us under the RTI Act, we were not able to find any CDL reports on the remaining four issues raised by Abraxis in its complaint. We, therefore, do not know if the health ministry has scrutinized all of the issues raised by Abraxis," added Reddy.
Biocon said it’s in silent period as the results are awaited next week.
Abraxis, which has been merged with Celgene Corp., declined to comment.
“These are company specific matters and we cannot make general comments without looking at files, which were closed long ago," a senior health ministry official said.
Natco gained media attention when it was granted India’s first compulsory licence to manufacture and sell foreign drug maker Bayer Healthcare AG’s liver cancer drug Nexavar in 2010. It launched a generic version of the drug at one-30th of Bayer’s price in India. Natco was also one of those that successfully opposed a patent for Swiss drug maker Novartis AG’s blood cancer drug Glivec in India. It also launched a generic version of Glivec along with at least a dozen other firms at a much lower price than that offered by Novartis.
India’s patent office had rejected a patent application filed by Abraxis Bioscience last year after Natco challenged it through the pre-grant opposition route. The matter is before the Intellectual Property Appellate Board (IPAB) after Abraxis appealed the patent office’s decision.
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