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!!!!!!!!!!!!!!!
Asia’s largest drug maker, Takeda, 
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.
Despite a stalling economy, there are signs that some American companies are hiring and helping to improve local economies. A good of example of this is Alcon Laboratories located in Fort Worth, Texas. The company, which specializes in vision products, 
Merck
While Samsung is mostly know for flat screen televisions and other electronic appliances, one of South Korea’s largest companies has been quietly evaluating a play in the protein engineering and manufacturing space. For those of you who may not know, Korea possesses one of Asia’s most vibrant biotechnology industries. At present, there are over 600 Korean biotechnology companies in existence. In April 2011, Samsung created a business units called Samsung Biologics which specializes in biopharmaceutical manufacturing..jpg)
It seems that big pharma always waits for early Fall to announce pending job cuts. Novartis, Europe’s second largest pharmaceutical company, 
Astra Zeneca today announced that it will eliminate 400 positions at the company’s Wilmington, DE headquarters. Most of the cuts will be in sales and marketing and the downsizing is intended “streamline portions of its commercial business to best serve patients in the US.”.jpg)
Conventional wisdom has it that when economic times are tough enrollment in graduate schools tends to increase. After all, there are no jobs to be had so jobseekers go back to skill to increase their knowledge or improve their skills to be more competitive on the job market. However, according to a 
By now, most of you have heard that tough economic times are forcing more students to enroll at community colleges because they can no longer afford the staggeringly-high tuition costs at most American four year public and private colleges and universities. While this may be a financial boon for community colleges, technical schools and for-profit educational institutions, flagging enrollment numbers at second and third-tier public and private colleges has induced some admissions officers at these four year institutions to lower academic standards to admit students who can pay full tuition to attend them. In other words, rather than admit deserving academically-qualified and competitive students who may need financial aid to attend their institutions, admission officers will sometimes admit less academically qualified students to offset rising financial costs.
As scientists, we all subscribe to the notion that diversity is a critical component to the evolution of any species. While we this is a well known fact, the life sciences industry, like others, struggles with workforce diversity mainly in the area of research and development. For example the number of minority students—blacks and hispanics—who receive PhD degrees is miniscule as compared with their white counterparts. Graduate schools struggle to promote diversity in their programs but their efforts to date have been lackluster.
The US is 
Unlike many of its big pharma competitors which are shuttering US manufacturing facilities, MedImmune, the biologics division of London-based pharmaceutical giant AstraZeneca, Friday, 
There is no question that the US is lagging behind other nations in science, technology, engineering and math. While this may be troubling to some, Americans possess one skill that provides them with an unheralded advantage; that is entrepreneurship. Entrepreneurial skills cannot be easily taught or learned. And while most Americans don’t know it, entrepreneurship is a passively acquired trait that most non-Americans would “kill for.” Unfortunately, the recent recession and increasing global competition had dampened Americans entrepreneurial enthusiasm to the point where risk-adverse business behavior is threatening to stifle US innovation.
While there is enormous unmet medical need out there, I never knew that the morbidity and mortality resulting from scorpion stings was so great. But, as the old adage goes; you learn something new everyday. To wit, the US Food and Drug administration earlier this week approved the first-ever treatment for scorpion stings..jpg)
The recent E. coli 0104:H4 outbreak of gastroenteritis in Europe that sickened thousands and killed over 20 people was one of the largest foodborne disease outbreaks in the world (for the latest updates check out this.jpg)
A 
Last week’s special issue of Nature Magazine.jpg)
I am not a big fan of top ten lists but I decided to take a look at the list compiled by Cecilia Capuzzi Simon in a recent article that appeared in the April 13, 2011 New Times Education supplement. Entitled
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. 
It seems like hostile takeover bids in the life sciences industry may be de rigueur (how can anyone forget the .png)
Let’s face it; most scientists are lousy communicators. While this is not an inherited defect, the poor communication skills exhibited by most scientists are a direct result of a lack of emphasis placed on oral and written communication skills during their training. In fact, being a “good communicator” may actually hinder a scientist’s success as a world class researcher. After all, prematurely divulging information or breakthroughs may result in being “scooped by the competition” both in terms of winning grant monies and publishing first. Consequently, from a Darwinian standpoint, good communications skills are a trait that may actually be selected against because they more than likely will reduce the overall competitiveness and “fitness” of most research scientists.
In his State of the Union Address last week, President Obama acknowledged that US global competitiveness in science, technology engineering and math is at an all time low and that now may be America’s “sputnik moment” to turn this trend around. While I was pleased to hear the President say that we have a problem, neither political rhetoric nor turning the lack of science literacy into a challenge that resembles an arms race is going to solve the problem. What is needed are better trained science teachers who can engage science-minded students and a repeal of the No Child Left Behind Act that forces schools to focus limited financial resources on bolstering math and reading scores to maintain public funding. Sadly, neither of these things is going to happen any time soon. But I digress...
I know that I have been blogging a lot lately about science and it importance in American innovation and global competitiveness. And, not surprisingly, some of you may be sick of hearing me drone on about it! But, if you want to get another perspective on the critical role that science plays in the lives of everyday Americans, you absolutely must read Tyler Cowen’s article in this Sunday’s NY Times 
In 2005, The National Academy of Sciences issued a worrisome report entitled .jpg)
Two years ago Merck 
Ed Silverman, author of the fabulous 
Sunday marks the beginning of “American Education Week”, the observance which was started back in 1921. It was created by the National Education Association (NEA) and other groups because 25% of World War I draftees were illiterate.
While I believe that tenure ought to be abolished and the cost of a college education is way too high these days, I cannot fault non-profit post secondary educational institutions for the job that they do educating students and preparing them for life. Most do a pretty good job despite the outrageous price tag..jpg)
About 10 to 20 Americans are afflicted with bubonic plague each year, and 1 to 3 die from the infection according to statistics compiled by the Centers for Disease Control in Atlanta, GA. The natural reservoir of Yersinia pestis, the bacterium that causes plague, are 
I counsel a large number of foreign students as part of my career development activities. Over the years, I learned that questions regarding a job candidate’s personal information like nationality, religion, marital status etc are permissible and perfectly legal in countries other than the US. Consequently, I decided that it may be instructive for job candidates to learn what questions are acceptable and those that are not during a face-to-face interview for positions at US companies. 
There was an extremely troubling article in today’s 
As many of you know, I am a big 
John Lechleiter, PhD, chairman and CEO of Eli Lilly & Co. today told members of the Detroit Economic Club that the US is losing its competitive edge and that “evidence is mounting for an .jpg)
Earlier this year, Dan Vasella, the longtime CEO of the Swiss drug maker Novartis, .jpg)
One economic downturn and it seems as though the pharmaceutical world has been turned upside down! Who would have thought a few years ago that emerging pharmaceutical markets in India and Asia will outpace the US and Western European markets in the very near future (I did but nobody listens to me). To that end, Ranbaxy Laboratories 
While studying the pathogenesis of Neisseria gonorrhoeae in Portland, OR in the early 1980s, genital herpes had replace gonorrhea as the scourge of the sexually transmitted disease community. To help to combat the spread of genital herpes, my labmates and I joined the Portland Venereal Disease Action Committee, a grass roots organization that provided public outreach and education about sexually transmitted diseases (STDs). A few years later, the Regan Administration finally admitted to the American public that HIV/AIDS was real and that HIV infections were likely to reach epidemic proportions. While genital herpes can be painful, uncomfortable and often emotionally debilitating, the unprecedented morbidity and mortality of HIV/AIDS almost pushed genital herpes into infectious diseases obscurity. Now that HIV/AIDS is more treatable than ever before, epidemiologists and sexually transmitted diseases experts have begun to reexamine the infection rates and incidence of other STDs (including herpes, gonorrhea, Chlamydia and syphilis) among Americans. To that end, I read today a .jpg)
In case you did not know, the 
Ed Silverman, who runs the 
For the past decade or more, small to mid-sized biotechnology companies had been outsourcing production of their preclinical and clinical protein-based products to Asian contract manufacturing organizations (CMOs). This was because manufacturing and labor costs were lower and product quality was consistent with Western standards and requirements. However, the recent economic down turn coupled with rising prices at Asian CMOs (mainly driven by increasing labor and project management costs) has 
Despite the announcement late last week in the London Sunday Times that (2).jpg)
Alan Alda, a well known actor and science enthusiast, is doing his share to improve the science literacy of Americans. His was the host of the Science Frontiers (which ran for 15 seasons on PBS until it was cancelled in 2005) and more recently the host of Wired Science which failed to catch on and was also canceled. Alda’s approach to science education is asking questions that nonscientists could understand while throwing in a bit of humor as well. In a
Much has been written about how supportive the pharmaceutical industry has been about US healthcare reform. Prior to the debate, the Obama administration gleefully announced that pharma will give $80 billion in drug discounts in exchange for certain assurances that weren’t publicly disclosed. As most of us know, the US House of Representatives passed historic healthcare reform legislation last week and in addition to a public option it stipulates that pharma will be required to give $140 billion in drug discounts. According to Ed Silverman over at the newly reinstated .jpg)
The bad news is that the US unemployment rate is close to 10 percent. The good news is that the government is looking for scientists at FDA, NIH, USDA, CDC, EPA and other agencies. For those of you who haven’t applied for a government job, the process can be daunting and overwhelming. To alleviate some of the pain, Cyndi Fischer, MSA at the 
Sepracor shareholders may be able to sleep better at night without the aid of the company’s top selling insomnia drug Lunesta after agreeing to be purchased on Thursday by Dainippon Sunmitomo Pharma of Japan. Dainippon will pay $2.6 billion for the rights to Lunesta and other drugs in Sepracor’s pipeline. .jpg)
Reuters reports 
Several weeks ago, I (1).jpg)
The 
A survey involving 2000 members of the public and 2500 scientists conducted by the Pew Research Center for the 
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: 
A much-anticipated .jpeg)
After months of complaints by university officials and scientific organizations, the US State Department 
The Biotechnology Industry Organization (BIO) kicked off its annual meeting in Atlanta, Georgia today and shortly thereafter, issued a .jpg)
Do you lie awake a night overwhelmed by the possibility of another infectious disease outbreak? Well, if you want to get a good night’s sleep, I highly recommend that you take a look at a brief history of American epidemics that was published in this past Sunday’s New York Times. According to the .jpg)
Previously, the US Congress proposed legislation to create a regulatory approval process to allow the Food and Drug Administration (FDA) to approve generic versions of blockbuster biotechnology drugs known as follow-on biologics (FOBs). While a regulatory pathway exists for approval of generic versions of small molecule drugs (as outlined in the .jpg)
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Recently, I have come across posts on blogs and websites reporting on lay offs and cost-cutting measures that are taking place at some biotechnology companies. A good example of this is a post that appeared yesterday on the Fierce Biotech Web Site. The headline read: .jpg)
We in America have grown accustomed to the constant barrage of .jpg)
The Pharmalot blog reported yesterday that 
Each year the World Bank compiles a report that assesses the world’s friendliest business climates for small companies. The top three companies on this year’s list, Singapore, New Zealand and the US have been there four years in a row. The real shocker this year was that several previously lagging nations moved up on the list, mostly because of business-friendly reforms. This year’s most improved nation is Azerbaijan, which moved up 64 spots to a overall ranking of 33rd because it reduced the time required to start a new business from 122 to 16 days, reforming its civil code and creating an online tax filing system..jpg)
Like my kids frequently say when I mutter something obvious…”Like..DUH.! According to an 
Siemens, the German conglomerate that manufactures everything from locomotives to medical imaging devices, officially announced on Tuesday that it will be sacking 4% of it workforce or 16,750 employees. Although the company didn’t specify where all of the cut would be taking place—it is a global workforce reduction—a company spokesperson did indicate that 1,500 administrative jobs in its healthcare division would be eliminated and most of those jobs are in the US. Many of these cuts will likely take place in the tri-state area (New York, New Jersey and Pennsylvania)—not welcome news for the already battered pharmaceutical and biotechnology industries in the region.
Ed Silverman over at Pharmalot reported today that Health Canada, the Canadian equivalent of the FDA has beaten the 
The Bush administration's proposed 2009 fiscal year budget for the FDA