Zydus Life's plans for cancer biosimilar hit a legal hurdle
Remove Ads
Tired of too many ads?
Remove Ads
Mumbai: The Delhi High Court has issued an interim injunction against Ahmedabad-based drug maker Zydus Lifesciences after a case filed by the US pharma giant Bristol Myers Squibb alleging patent infringement on its blockbuster anticancer drug Opdyta nivolumab ) branded as Opdivo in other countries.The restraining order comes as a setback for the Indian drug maker which was running clinical trials in India for the launch of the biosimilar versions of nivolumab. The earliest patent for the drug expires in India on May 2, 2026. The next hearing for the case is August 8.The 101-page order issued on July 18 by Justice Mini Pushkarna ruled that the defendants, and all others acting on its behalf, are restrained from manufacturing, using, selling, offering for sale, importing, exporting, advertising, or dealing in any biosimilar/similar biologic of nivolumab, the suit patent, during the pendency of the present suit. The order stated the plaintiffs shall suffer irreparable loss, in case the interim relief as prayed for, was not granted.Opdyta injections are one of the many latest generation immunotherapy drugs also known as checkpoint inhibitors increasingly used to treat several types of cancers including skin, lungs, kidneys, and Hodgkin lymphoma. It works by activating the body's T-cells or immune cells by targeting a protein called PD-1, thereby unleashing an attack on the cancer cells.Opdyta vials are sold in India for roughly '2 lakh but for patients who are part of the company's assistance or access programs, the drug is available at a slab-wise discounted rate.While the India data is not available, globally Bristol Myers Squibb recorded Opdivo sales of $9.3 billion in 2024. Indian companies have launched biosimilars at half the cost of those charged by their global counterparts.Experts in Indian patent laws told ET that the court has taken a view that stockpiling of a product during its active patent life amounts to infringement and to release it or flood the market is not legally valid."This opinion may have implications for the other ongoing disputes like the weight-loss drug semaglutide (branded Wegovy) case between Novo Nordisk and Dr. Reddy's Labs or Roche versus Natco for Risdiplam (drug used for a rare disease called spinal muscular atrophy or SMA) case," a senior lawyer said.The petition from BMS noted that Zydus Lifesciences was conducting clinical trials for nivolumab and on its investigation found that the company had plans to launch it during the patent period. The Indian company, it said, had applied for a marketing approval with the central drug regulatory agency.For its part, lawyers on behalf of Zydus defended saying its product ZRC-3276 does not infringe upon the existing patents and is following the regulatory provisions.Zydus was represented by a battery of top lawyers including Harish Salve, Dushyant Dave, and Rajiv Nayar, while Squibb & Sons was represented by Sandeep Sethi, PS Raman, Amit Sibal and Pravin Anand, among others.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Economic Times
16 minutes ago
- Economic Times
Valuations may be high, but India's long-term story remains unshaken: Swarup Mohanty
ET Bureau We have to grow at 6% is our house commentary, but that 6% versus 2 and that is something which people need to internalise. "While there is an impact of tariffs, we can be on our own in our own capacity and then that is something which we need to realise that our cars can be consumed by our own people," says Swarup Mohanty, VC & CEO, Mirae Asset Investment Managers. So, much work goes on behind what you do, I mean 17 years old fund, I was just looking at that, 45 number of schemes and an aum size of over two lakh crores. What does it feel like to have this kind of journey clocked in in 17 years. Swarup Mohanty: No, it is a very humbling experience. First of all, always a humbling experience to be in a fiduciary role. I mean to enjoy the trust of somebody else's money is very overwhelming to start with and then when we started as a global asset manager, today we stand in India as the only organic global asset manager in the country. It has not been very easy for global asset managers and then to be sitting with over 70 lakh folios is something which we had not thought of. Maybe AUM we would have thought of, but to be enjoying so many investors trust is pretty overwhelming. One is… That is the India story right, rising with India. Swarup Mohanty: Yes, absolutely, rising with India. But this 17 years of experience, you are a Korean company, India as a market was something that I do not think so Korean at that time must have thought that will flourish like this. I really want to understand the transition in last 17 years as an Indian investor as a Korean company that you have witnessed. Swarup Mohanty: I must tell you that our chairman Mr Hyeon Joo Park is a fund manager himself. He started the mutual fund industry in South Korea. We are probably the first financial company to set out of South Korea to build base. We came in 2006-2007 and when the team came to India and then there was this call from here to our chairman why are we here, there is nothing here, the reply was that is exactly why we are here. Trust me and I got the chance to narrate the same story to the prime minister of this country is that sometimes I wonder what they see in India that we do not see. They are so one-sided in their view on the structural growth of this country is incredible to sort of note because I have sat in rooms of 200 people, 199 Koreans and me the only Indian and on stage our chairman says that only one country will flourish in the next 10 years. One country when you single out, you sort of think what is happening. Maybe they can see things more in a neutral manner from the outside, some things we get a little biased about. We were just discussing the more boring the more biased you make it, the better the outcome. But having said that in the last 17 years and we must give credit where it is due, the Indian investor also has come a long way. I mean, 17 years back who would have thought that your fund alone is going to manage the AUM size that you have. Having said that, the Indian investor always gets edgy with the news headlines and all the noise around. What is it that you are making of all that is happening right now, this concern around what is going to happen with the tariffs, what is going to happen on the global slowdown front and of course, the India story wherein valuations are always a question mark. Swarup Mohanty: Yes, one, of course, when a country like the US starts changing in behaviour, everybody else's behaviour also starts changing, we are in that phase. But as this I mean tenure starts expanding, people will accept that and form their own opinion. I personally feel that from defence to capital markets every country is now reworking its own strategy, that is the time and such a phenomenal time to be sitting in the world at this moment and then probably each country will start defining their own style in the world and then probably India will shine in that is my bet on it. The second part is from the investors. I mean today if you look at the market and all of you kind of talk about it many times is that the market shifted to that single retail investors who have come together and piled this 26,000, 27,000 crores of support to the market on a monthly basis and that is where is the behavioural shift. I had not thought that I would see this before my retirement. I would joke about it, but it is so fascinating to see that and as the demography is shifting, right now three generations are investing together which had never happened in my career. My father's generation, my generation, my sons, my sons' generation is something which will turn it around. I am extremely bullish of their behaviour. I am very confident of their ability to see the long-termness if there is a word like that of the India story and good days ahead is what I can say. But what do you make of the current market construct? Like we are saying with all the talk around tariffs and still question mark on which way the tariffs are going to go for India and we are still awaiting that 'letter' and valuations which are not really as comfortable as we have seen in the past. What is the next one year looking like with all the uncertainties around? Swarup Mohanty: My personal take is India is a structural growth story that is a given globally. If there is a growth story, it is India. So, based on that India will definitely have its own negotiation powers, negotiation levers when it comes to that negotiation table for the tariffs. I mean, the fact is every country would like to participate in this country because wealth is being created at an individual level as we speak and it will be the largest consumption market a third probably to US, China we are there. So, while there is an impact of tariffs, we can be on our own in our own capacity and then that is something which we need to realise that our cars can be consumed by our own people. Our produce can be consumed by our own people. So, net-net we are at this moment a very isolated story from the rest of the world. When you do the headlines compare whether those headlines appeal to our country, it is very strange to say that India will remain isolated on data points and strong consistent data points. While some of us get disappointed when growth comes down to 6%, world is growing at 2-3%. It is not good. But we get disappointed at 6%. We have to grow at 6% is our house commentary, but that 6% versus 2 and that is something which people need to internalise. But we need to have high benchmarks for our market. Swarup Mohanty: We should.
Mint
16 minutes ago
- Mint
India Consumer Earnings Key as Markets Hope for Demand Rebound
(Bloomberg) -- Asia's earnings focus turns to India's consumer sector, as investors look for signs that economic momentum is recovering after central bank rate reductions and income tax cuts take effect. Efforts to shore up the Indian economy are under way as it gradually recovers after a consumption slowdown last year. The Reserve Bank of India has cut the key rate by a cumulative 100 basis points so far this cycle, with the governor in June declaring the battle against inflation had been won. The country's two largest private sector lenders HDFC Bank Ltd. and ICICI Bank Ltd. both beat profit estimates on Saturday. India's new tax bill also exempts 11 million more people from income taxes, another move to boost consumption in Asia's third-largest economy. On Thursday, Nestle India Ltd. should show improved volume growth led by a recovery in rural demand, with urban recovery yet to catch up. It's also expected to benefit from a cut to palm oil duty and fall in coffee prices, according to analysts from Nuvama Institutional Equities. Tariff concerns will cloud Infosys Ltd.'s Wednesday update after rival Tata Consultancy Services Ltd. said many American clients were cautious about tech investments given ongoing economic uncertainty. Shares in Tata Consultancy Services, HCL Technologies Ltd. and Tech Mahindra Ltd. all fell after their earnings reports, with the latter two missing estimates. Highlights to look out for: Monday: Eternal's (ETERNAL IN) first-quarter profit is expected to halve on losses at its quick-commerce business Blinkit. The unit is investing in expanding its 'dark stores' network, where it services quick-commerce orders, and analysts will watch for updated guidance on when profits are expected. Strategic steer on its new 'Going Out' business will equally be in focus. Tuesday: No major earnings. Wednesday: Infosys (INFO IN) could lower or pull its revenue growth guidance as demand for new projects deteriorates amid worsening economic conditions, BI said. Watch for commentary on whether clients are canceling projects, especially in industries hit by US tariffs, Kotak Institutional Equities said. Thursday: Nidec's (6594 JP) sales would likely be affected by uncertainties in the auto market, as demand for electronic parts and motors slow in Japan, according to BI. Founder Shigenobu Nagamori said the firm's appetite for takeovers remains intact, following its earlier decision to withdraw a $1.8 billion hostile bid for Makino Milling Machine Co. Friday: No major earnings. More stories like this are available on
Mint
16 minutes ago
- Mint
JSW Steel gets back its lustre in Q1; safeguard duty provides support
JSW Steel Ltd's consolidated Ebitda jumped 38% year-on-year to ₹7,600 crore in Q1FY26, thanks to lower raw material costs, royalties and higher volumes. Ebitda per tonne rose 26% to ₹11,324 when overall revenue was little changed at ₹43,100 crore. Prices haven't recovered fully. While blended realization at ₹64,500 per tonne is up about ₹3,300 from the lows in Q4FY25, it is about 8% down year-on-year. The Indian steel industry got a push after the imposition of safeguard duty in April, which led to a notable 34% sequential drop in imports in Q1. JSW's sales grew by 9% to 6.7 million tonnes, with domestic volumes up by 12%. The management expects sales to reach 29.2 mt in FY26, up 13% year-on-year, backed by strong domestic outlook. While prices moderated in July with lower construction activity, the outlook is better. 'Domestic steel prices bottomed out in mid-July and should recover post-monsoon," Nuvama Institutional Equities said in an 18 July report. It projects JSW's FY26 Ebitda growth at 47%, aided by higher volumes, prices and lower raw material costs. Among sectors, consumer appliances and automotive saw robust growth of 27% and 20%, possibly in anticipation of a sales pick-up in the upcoming festive season. Also, the US business reported positive Ebitda against a loss in the previous year, thanks to 18% volume growth and higher realization. Yet, with 4% contribution to total volumes, its impact on consolidated financials was limited. Expansion projects JSW is undertaking significant capital expenditure towards capacity expansion and backward integration projects to leverage strong domestic demand. The 5 million tonne per annum (mtpa) expansion at Vijayanagar will likely provide incremental Ebitda of about ₹1,500 per tonne with higher operational efficiency. Besides, the commissioning of three iron ore mines this year would help it achieve 40% raw material security against 36% in FY25. JSW's total domestic capacity is expected to reach 41.9 mtpa from the current 34.2 mtpa, with the commissioning of the Dolvi phase III expansion and other smaller projects by September 2027. The FY26 capex plan is ₹20,000 crore, up from ₹14,700 crore in FY25. Still, strong cash flows helped JSW reduce its net debt-to-Ebitda to 3.2x in Q1 from 3.34x in Q4FY25. The stock trades at an enterprise value of 9.4x FY26 estimated Ebitda, near its five-year average, Bloomberg data shows. Post-monsoon price trends and a volume ramp-up should provide further cues for the stock.
