Intellectual Thoughts by Sanjay Panda: June 2009

The Biosimilars- Future of cure

The future of pharmaceutical industry now seems lies with the biotechnology as there is a growing resistance to the use chemical based drugs world over. Biopharmaceuticals thus becoming the fastest growing segment of the pharmaceutical market today. Nearly a quarter of the top 100 drugs in 2007 were biologics and 13 of them achieved blockbuster status of more than $2 bn in worldwide sales. Both generic drug manufacturers and large pharma companies are angling for a share of this emerging niche in the $75 bn global market for biosimilars. Generic drug maker, Sandoz has already taken the lead on this segment with three biosimilars approved in Europe namely Omnitrope, Binocrit and Zarzio. Teva pharmaceuticals, a leading generics producer, has plans to become a major player in biosimilars. It has one product on the European market (Tevagrastim) and has improved its capabilities in biopharmaceuticals through the recent acquisitions of Barr Pharmaceuticals and CoGenesys in the US. Teva's strategic partnership with Lonza to jointly develop, manufacture and market biosimilars confirms its resolve to enter into biosimilar market in a big way. Merck & Co has recently established Merck BioVentures and agreed to purchase a portfolio of biosimilar candidates and commercial manufacturing facilities from US-based Insmed. Indian manufacturers such as Ranbaxy, Dr. Reddy's Lab, Biocon and Wockhardt, have also plans to venture into biosimilar market by taking approvals in Europe and, ultimately, in the US.

Biosimilar products do attract a lot of interest and controversy. Because, biological drugs are complicated and expensive and used to treat complex conditions. A key point for developers of biosimilars is the issue of interchangeability. This is going to be a hard sell in the regulated markets where prescribing of chemical generics is already unpopular. The task will be more difficult for biosimilars where worries over equivalence will be greater and less easy to counter. With a regulatory framework already in place in the European Union to address the safety of biosimilars, the opportunity represented by these products has been proven and is growing there. Over 10 biosimilars have been approved in Europe, using the EU's specially adapted approval procedure. In Japan, the first biosimilar has been submitted for review recently. But, the US, the largest pharmaceutical market, is yet to open up for biosimilars as the biotech industry there is strongly opposed to the entry of biosimilar products. Introduction of biosimilars in the US market should bring down the cost of medicine substantially for critical diseases and make them available to a wider population. And that depends on the US government. If the proposed legislation before the US Congress is passed without much changes it should alter the whole look of the global biopharmaceutical industry to the advantage of millions of patients who are now denied of the benefits of advanced but expensive biologics.


Factory Output Rise Adds To Revival Signs!!!! or just an effect of stimulus packages

India's industrial output rose in April, beating forecasts for a fall, driven by a pick-up in domestic demand that analysts said confirmed nascent signs of recovery and an end to the central bank's rate-cutting cycle. Factory output in April rose 1.4 per cent from a year earlier, recovering from a revised fall of 0.8 per cent in March and bettering forecasts for a decline of 0.2 per cent, adding to signs from China that activity in emerging economies was picking up.

Figures from China showed factory output growth rebounded in May alongside stronger expansion in credit and consumer spending, adding to hopes it can lead a global revival.

Manufacturing output, which accounts for 79 per cent of India's industrial production, rose an annual 0.7 per cent in the first month of the 2009/10 fiscal year.

The benchmark 10-year bond yield rose 6 basis points to a two-month high 6.94 per cent on the data, which was seen confirming an end to the central bank's aggressive rate cuts since last October.

Before the April rise, output had fallen in three of the previous four months. The data also reinforced other signs that domestic demand was picking up in India. Stronger-than-expected March quarter growth helped Asia's third-largest economy to expand by 6.7 per cent in 2008/09, although that was a six-year low and well below rates of 9 per cent or more for the previous three years.

The signs of a bottoming in growth and the re-election of the ruling coalition have seen economists revise up their forecasts for 2009-10, with the central bank's estimate of about 6 per cent now at the bottom of private sector economists' expectations.

Car sales rose an annual 2.5 per cent in May, climbing for the fourth month, and strong demand in rural and semi-urban areas pushed up motorcycle sales by 12.3 per cent from a year earlier.

Infrastructure output, accounting for a quarter of factory production, grew 4.3 per cent in April from a year earlier, data showed earlier this month.

A survey of purchasing managers last week showed manufacturing expanded for a second month in May to its highest in eight months.But exports remain in the doldrums, and the government expects their decline to continue until September. Exports fell 33.2 per cent in April from a year earlier to $10.74 billion.

Although India is less dependent on exports than China or other East Asian countries, with exports accounting for about 15 per cent of GDP, the sharp drop has offset some of the domestic gains.


Reliance Industries's German Unit Goes Bankrupt

The global economic downturn has hit India's most valued company Reliance Industries, forcing it to today to declare as insolvent its German unit Trevira, a specialty polyester manufacturer. Reliance Industries had acquired Trevira five years ago for Rs 440 crore. This acquisition in 2004 had propelled Reliance to the position of the world's largest polyester fiber and yarn producer. The German unit had 1,800 employees as of March 2009 and a turnover of Euro 323 million last year.

Trevira faced severe demand contraction in its principal market segments due to the global financial crisis .Trevira, which was part of German industrial conglomerate Hoechst AG before being acquired by Reliance, manufactures high-value branded polyester fibers and filament yarns or the automotive industries, home textiles as well as for technical applications. Trevira has production units in Germany, Denmark, Poland and Belgium.