Sandoz Moves Its Biosimilar Development Strategy Forward
Sandoz, the generics division of Novartis, is currently the world leader in the biosimilar market. In fact, if it was not for Sandoz, the biosimilar industry may never have gotten started in the first place! As some of you may know, Sandoz sued FDA (and won) to gain approval of its biosimilar human growth hormone. While FDA contends that Omnitrope is not really a biosimilar (it was approved as a “drug” rather than a biologic) most analysts agree that it was the first biosimilar product ever approved and sold in the US.
As part of its global biosimilar strategy, Sandoz today announced that it had initiated Phase III clinical trails for US approval of biosimilar version of recombinant human granulocyte-colony stimulating factor(G-CSF) or filgrastim (Amgen’s Neupogen®) and another for global launch of PEG-filgrastim (Amgen’s Neulasta®); a PEGylated form of G-CSF.
The filgrastim study is designed to evaluate the efficacy and safety of Sandoz's biosimilar filgrastim versus Neupogen® in breast cancer patients eligible for myelosuppressive chemotherapy treatment. These trials expected to support extension of commercialization to the US, the largest global market for biologics. The pegfilgrastim study, which is being conducted in breast cancer patients undergoing myelosuppressive chemotherapy treatment, represents the next major step in the Sandoz global biosimilar development program. Previously, Sandoz announced that it had initiated late stage clinical trials for a biosimilar version of Roche’s monoclonal antibody cancer treatment Rituxan®). Finally, Sandoz has eight to ten different biosimilar molecules at various stages of development in its pipeline.
Sandoz currently markets and sells three biosimilars: filgrastim (Zario®), somatropin (Omnitrope®) and epoetin alfa (Binocrit®) in countries across Europe and elsewhere. As mentioned above Omnitrope is also sold in the US. However, because FDA has yet to craft a regulatory approval pathway for biosimilars (despite legislation mandating their approval) it is illegal to sell biosimilars (with the exception of Omnitrope) in the US.
Once vilified and staunchly opposed by most major pharmaceutical and biotechnology companies, the biosimilar business has been picking up steam in the past few years. To that end, companies like Merck, Pfizer, Teva and more recently Amgen and Biogen (all of whom lobbied against an approval pathway for biosimilars in the US) announced plans to compete on the global biosimilar market.
The decision of these companies to enter the biosimilar market is largely a result of downward pricing pressures on pharmaceutical and biotechnology drugs and near-empty drug pipelines at most major life sciences companies. Nevertheless, it is still not clear whether or not a robust biosimilar market truly exists. To wit, biosimilars have been in the market in the EU for the past fiver years and have not gained much traction there. However, the real biosimilar markets probably exist in China, Brazil and other emerging countries where there are large populations and emerging middle classes but drug prices are under tight government regulation. Because of this, the uptake of biosimilars in these markets will likely be greater than in Europe and the US.
Until next time...
Good Luck and Good Job Hunting!!!!!!!!!!!!!!!
Much has been written about the emerging markets in China. While there are likely thousands of business article and white papers on China’s economic expansion, I was unable to find a single source that provided me with some vital economic and social statistics to explain China’s rise as an economic power; that is until I received OnWisconsin, a quarterly publication from my alma mater the University of Wisconsin-Madison.
The German pharmaceutical company Boehringer Ingelheim (BI) today announced that it plans on investing 70 million Euros to expand its manufacturing facility in the Zhangijiang High-Tech Park in Shanghai China. The expansion will continue through 2013 and the number of employees will increase from 240 to 400 at the new facility.jpg)
The Pharmalot blog
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It seems that big pharma always waits for early Fall to announce pending job cuts. Novartis, Europe’s second largest pharmaceutical company, 
British pharmaceutical giant AstraZeneca today announced that it would invest $200 million into a new manufacturing facility located in China Medical City in Jiangsu province in Eastern China. This is the company’s largest global investment ever in a single manufacturing facility. The new plant which will be completed by 2013 will manufacture intravenous and oral solid drugs. 
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During the Bush Administration I, along with many others, was a harsh critic of the US Food and Drug Administration (FDA). The criticisms that I levied against the agency were mainly based on its inability to adequately maintain the safety of the American drug and food supply and Bush’s repeated attempts to politicize the organization and render it useless. That said, it is amazing how much has and will change at the agency during the Obama Administration. To wit, Margaret Hamburg, the current FDA Commissioner yesterday
Over the past week or so there have been daily snippets on various media platforms about business deals and opportunities in the Indian and Chinese life sciences market. While it is not news that many life sciences companies are expanding operations into these markets, the growing frequency of news items about the “goings on” in both markets are noteworthy.
Not too long ago, the mere mention of the word “vaccine” caused most big pharma executives to break out into a cold sweat. Once derided as low margin products and potential market busters—once most populations are immunized the incidence of disease declines and the market begins to falter—vaccines, primarily pediatric ones, have made a huge comeback over the last five years. 
The clinical trial phase of the drug development process is labor intensive, costly and usually takes the largest amount of time to complete. In the past, most human clinical trials for new molecular entities discovered by American scientists were conducted in the US. However, growing healthcare costs and shortages of “treatment-naive” trial participants have forced drug makers to take the effort global. To that end, many companies now routinely conduct Phase I (safety) and Phase II (proof of principle) trials in Eastern Europe, Latin America and Asia. Moreover, a growing number of pharmaceutical companies are beginning to conduct pivotal Phase III trials in which a majority of participants come from outside of the US.
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"Instead of crying and blaming China for producing goods at a lower cost for the whole world, countries like the US, for example, should realize that outsourcing most of the production is a big mistake"
While R&D scientists and sales representatives continue to struggle to find jobs in the US at pharmaceutical and biotechnology companies, the competition is fierce to hire and retain pharma employees in emerging markets like China and India. Earlier this week, I posted a piece on big pharma’s continuing expansion of its R&D activities in Asia and the growing need for US-trained PhDs in this region. However, it appears that hiring and retaining pharma sales reps is a bigger problem in China and India for big pharma companies like GlaxoSmithKline (GSK), Sanofi-Aventis (SA) and Pfizer.
For the past three years or so, Eli Lilly CEO John Lechleiter has publicly criticized America’s lack of math, science and engineering preparedness. Further, he has lamented that this lack of preparedness has resulted in a lack of innovation and that it threatens the US standing as a leader in the pharmaceutical and biotechnology industries. Finally, Lechleiter squarely places the blame on American science educators. 
Unlike most of its competitors, which are downsizing operations, the Swiss drug maker Novartis 
Unemployment in the US is still hovering around 10% and in some parts of Europe like Spain it is closer to 20%. In marked contrast, the unemployment rates in Australia (5.1%) Hong Kong (4.5%) and Singapore (2.2%) are much lower. With the exception of Japan, Asian economies have rebounded more quickly from the global recession than those in the West.
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It is no secret that growth of the pharmaceutical industry has slowed to single digits in the past five years or more. In fact, many experts don’t expect there to be double digit growth in this sector for a long time. Instead, future robust growth of the pharmaceutical industry is expected to take place in emerging markets including India, China, Brazil, South Africa and others. This is because the economies of these countries are booming and the middle class in these nations continues to rapidly grow. 
Until recently, there was little or no mention of business activity within the emerging Chinese life sciences industry. However, as the Chinese middle class continues to grow, the need and demand for pharmaceutical and biotechnology drugs (including vaccines and other biologics continues) to grow at a frenetic pace. Further, a growing abundance of US-trained scientists has allowed the Chinese life science industry to develop much more quickly than anticipated. Also, many major pharmaceutical companies like Merck, Roche and Novartis have invested hundreds of millions of dollars in 
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The loss of over 200,000 pharmaceutical jobs over the past three years has been mainly driven by the anticipated loss of revenue from blockbuster drugs that will lose patent protection by 2013. While drug makers frequently cite blockbuster patent expiry as the reason for the need to downsize, they rarely provide the business and economic metrics, numbers and statistics that have influenced their decisions. 
GlaxoSmithKline (GSK) Britain’s largest pharmaceutical company
Pfizer 
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The 
that it has mapped the entire genetic code for the giant panda using DNA sequencing and analysis equipment from San Diego-based Illumina. The project began in 
From time to time, I come across some interesting facts and statistics that are worth noting. This month’s issue of Pharmaceutical Technology Europe offered several things that were blog-worthy. Here they are: .jpg)
The New York Times reported today that the Wuhan Zoo in Central China has taken to feeding its two 3-year-old pandas homemade chicken soup to reduce stress and provide them with a “nutritional boost.” Xiwang and Weiwei needed a boost after China’s weeklong National Day celebration. As many as 30,000 visitors swarmed the zoo this past Wednesday and over 1000 people packed into panda enclosure to see them. This caused the pandas to pace restlessly and zoo officials decided that it would be good to give them some chicken soup because they were “fatigued and had a bit of a shock.” Their normal diet consists mainly of bamboo, milk and buns..jpg)
Somebody once said “Jews know two things—suffering and where to find good Chinese food”. Since I am Jewish, it is not surprising that I have experienced a fair amount of suffering throughout my life and, wherever I go, I seem to know where to find “good” 
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Who can resist those adorable black and white Giant Pandas? Late last week, the International Giant Panda Genome Project was launched by Beijing Genomic Institute-Shenzhen, China. The goal of this project is to finish the sequencing and assembling of the draft sequence within six months. 
For the past year or more, the US media has been vociferously bashing tainted imported Chinese goods any time it can. The tainted products have ranged from toys to dog food and most recently to 