Excuse me, but if you really knew your science you would know that the term Biogenerics does not apply to Biotech drugs. Go back to your biochemistry class and then write a good article.

Merrill - Thanks for posting this. It's particularly interesting to me because biologics are currently the state-of-the-art in treating IBD - and they're terribly expensive. True biogenerics would be a huge relief to a lot of people, but it seems to me the market already has quite a lot of anti-TNF-alpha drugs - the original being Remicade, then Humira, and then Cimzia. Are these not similar enough to be "biosimilar"? Why were these drugs able to come to market, as opposed to other biosimilars? Would any of the proposed legislation change affect this market, if there are already competing similar biologics? I'm wondering if you have any further insight along these lines. Thanks - DX

The Innovation of Biologics (Specialty Drugs): How Is Value Defined Regarding Their Use?

Beginning in the late 1970s, biopharmaceuticals were being researched conceptually for potential creation in at that time in some academic institutions throughout the United States. And it was here that actual researchers in fact conducted basic research to identify new product candidates as they applied a great amount of time and effort fueled by their curiosity of what may be possible. This same protocol and passion is applied with biopharmaceuticals and the companies that create them today as it was then.
Known also as Red Biotechnology, it is believed that the first biopharmaceutical therapy ever was synthetic insulin called Humulin, which was made by Genetech in 1982, that utilized what is called rDNA technology, which also is used to produce human growth hormones. Later, the rights were sold to Eli Lilly for this insulin product. Yet Genetech was the catalyst and apex of biopharmaceutical growth then as it is now to a large degree. And such companies are truly research-driven. Today, they employ around 1000 scientists to continue their drive to research potential biologics. And with Genentech remains independent, although Roche owns a large portion of this company.
Biopharmaceuticals are distant and covert and distant relatives of big pharmaceuticals, whose medications are formed by synthetic small molecules, and are carbon based in their design. Due to the lack of innovation and creation of truly unique products in recent years utilizing this method, possibly, large pharmaceutical corporations in particular have become intimate with the innovative biopharmaceutical companies more often now than ever. In fact, large pharmaceutical companies often acquire biopharmaceutical companies that usually are comparatively very small start-up companies often. These large pharmaceutical corporations do this because, along with other reasons, biologics are in fact monopolies due to the undeveloped protocols for biosimiliars, which are the possible copy of what are the generic forms of typical branded pharmaceutical drugs. In addition, biopharmaceutical companies have historically experienced accelerated growth that has proven to be quite lucrative for them. Presently, this biologic industry is an 80 billion or so dollar per year franchise- with roughly 15 percent growth each year with this particular market, it is believed. It has been reported that are about 250 biologics on the market presently, with more to come.
How do these drugs differ from typical drugs that have been made before this advent of biopharmaceuticals? Unlike the small molecule, synthetic, carbon based pharmaceuticals of yesterday, biopharmaceuticals essentially are larger and very complex modified proteins derived from living biological materials, such as antibodies, hormones, or enzymes.
One method of these creations is that a transformed host cell is developed to synthesize this protein that is altered and then inserted into a selected cell line. The master cell banks, like fingerprints, are each unique and cannot be accurately duplicated, which is why there are no generic biopharmaceuticals as of yet, as there is no known process to create them. So the altered molecules are then cultured to produce the desired protein for the eventual biopharmaceutical product. These proteins are very complex and are manufactured from living organisms and material chosen for whatever biopharmaceutical that may be desired to be created. It is difficult to identify the clinically active component of biopharmaceutical drugs. So manufacturing biopharmaceuticals clearly is a different and innovative process, and a small manufacturing change could and has raised safety issues of a particular biopharmaceutical in the developing process, as altering the immune system of a potential user of a biologic therapy is risky. Also, it takes about 5 years to manufacture a biopharmaceutical. And each class has a different method of production and alteration of life forms to create what the company intends to develop. Yet overall, their development methods are rather effective, and cost over a billion dollars to bring to market.
However, there is a risk with biologics themselves, as they alter the immune system of the one receiving biologic therapy intentionally. For about the past 10 years or so, about 25 percent of biologic therapies have had one or more safety-related actions since the time these biologics were approved for marketing. Greater than 10 percent of biologic therapies have black box warnings now with their prescribing information, which indicates a higher level of risk than with other medications. Yet, since the advent of biologics about 30 years ago, the safety of these therapies have been progressively increasing as new therapies are brought to market. Yet the safety issue could be further improved by the FDA increasing their investigation of a biologic agent that is being considered for marketing approval, as well as increased reporting of adverse events after the biologic agent is approved.
Over 20 biopharmaceutical drugs were approved in 2005, it has been reported, and their growth has tripled compared with what the large pharmaceuticals experienced then. Presently, over 20 biopharmaceutical products are blockbusters by definition, according to others. They are overall very effective treatments for what are viewed as very difficult diseases to manage and treat. This is due to the fact that some biologics target specific etiologies of these diseases, while limiting side effects because of the specific way in which such products work. Yet of the nearly 400 biopharmaceutical companies that are publicly traded, about a third are more or less going broke, it has been reported presently. The industry employs about a quarter of a million people in the united states, it is believed.
Unlike traditional medications that have been created in the same way for decades, biopharmaceutical companies seek through their research specific disease targets by genetic analysis and then search for a way to manipulate this target in a very specific way to provide superior treatment for such patients. Furthermore, these products are biologically synthesized and manipulated to maximize their efficacy while not crossing into a patient’s bloodstream.
There are about a dozen different classes or mechanisms of action of biopharmaceuticals that have about a half of dozen different types of uses today. Label alterations for additional disease states occur often as well due to the progressive and novel effectiveness of biopharmaceuticals. Some of these drugs are catalysts for apoptosis of tumor cells. Others may cause angiogenesis to occur to block blood supply to the tumors of cancer patients. Then some biopharmaceuticals have multiple modes of action that benefit certain patient types and their diseases greatly, as with most biopharmaceutical products, the safety and efficacy is evident and reinforced with clinical data and eventual experience with the biopharmaceutical that is chosen to be utilized. And this clinical data is of a different method as well in comparison with what are traditional medications. For example, patients in the clinical trial involving a pharmaceutical are profiled, which allows better interpretation of this clinical data on their products.
The country of Belgium provides the most biotech products to the biopharmaceutical companies in the United States, and the U.S. leads the world in regards to biopharmaceutical product creation- with more than 70 percent of both revenues and research and development expenditures in this country. Canada is ranked number two in this area, others have said.
And with the government health care programs who are the largest U.S. payers for pharmaceuticals, Medicare pays 80 percent of the cost of biopharmaceuticals, as many are administered in the doctor’s office, and Medicare part B covers the cost in large part for biologics.
One issue with biologics is overuse or inappropriate utilization of these therapies, and biopharmaceutical companies are not exempt from federal prescription regulation that exists presently. Amgen, who makes an anemia biologic called Neupogen, recently had to pay a settlement as well as JNJ, who makes an identical drug called Procrit, for rebates and incentives both companies were giving to the users of their products, which were very lucrative benefits, and this resulted in some cases intentional overdosing their patients with these biologics at unreasonable and unnecessary levels, it has been reported. The doctors targeted with these biologics by the makers of these agents are nephrologists and oncologists, as anemia is often seen in their practices for various reasons.
Another controversy involving biopharmaceuticals is that, while they overall are efficacious and safe, the typical cost of biopharmaceuticals is rather unbelievable, as this cost may approach tens of thousands of dollars per month for some of these biologics. Furthermore, with cancer drugs, they are used together with chemotherapy for their treatment regimens in many treatment centers, so the quality of life comes into question if one considers the devastating side effects of chemo treatment. Another criticism of biopharmaceuticals is that, with cancer patients in particular, they normally provide an extension of their life of only a few months. So there is a debate as to whether the value of biologics justifies their cost.
Several years ago, I heard a presentation from Roy Vagelos, former CEO of Merck Pharmaceuticals, and heard him as he spoke to others at Washington University in St. Louis about his views on both the pharmaceutical and biologic industries. And during his presentation, he stated something similar regarding the cost of biopharmaceuticals and asked as well about whether or not the value related to the cost of biopharmaceuticals is truly clinically beneficial for such a brief life extension of cancer patients in particular, for the most part. I happen to concur with his premise.
So there are apparent controversies associated with these unique paradigms and innovations. Yet there are only a few biopharmaceuticals out of many available with debatable benefits with the high price tag. It ends up being what the market will bear for what their makers charge others. Yet the real question is the clinical evidence behind biopharmaceuticals: If a biopharmaceutical stops tumor progression without harming such patients and really extends their lifespan with efficacy that is obvious, then the benefit of such a biological is rather clear. Yet others have argued about the benefits of biological therapies, overall.
Another difference with biopharmaceuticals is that they are also are additionally regulated by what is called The Public Service Act, and are involved in authorizing the marketing of biopharmaceuticals.
With many biopharmaceuticals, such as those used to treat cancer, between 70and 80 percent of them are believed to be prescribed off-label, so it will be interesting on how these drugs will be used in such disease states now and in the future, and how they will be regulated as well.
So the future looks good for this industry, as biologics have tremendous marketing power along with superior therapeutic value with some of the products available, but not all of them. Perhaps they need to improve their absurd cost structure with their agents, as this may improve any negative image others have of the industry now or in the future. A more aggressive approach to bringing to market biosimiliars would enhance the image of this new industry.
Regardless of the challenges and flaws that exist with biopharmaceuticals and their makers, I’m pleased to see the results and realization of true innovation in pharmacology by taking a different path of drug development. Furthermore, I believe others should behave in a similar manner and be inspired by the biopharmaceutical companies and what they have done and continue to do for the benefit of patients regarding the issue of innovation.
“The progressive development of man is vitally dependent on invention.” --- N. Tesla
Dan Abshear (what has been written is based upon information and belief)

Excuse me, but biogeneric is a useful concept for regulatory purposes. Every cell line is different. But if the protein and its glycosylation pattern are the same, then it qualifies, IMHO, as a biogeneric. Biosimilars like Aranesp, on the other hand, are proteins that have been engineered to have different glycosylation patterns so it takes longer for the body to break them down. Given their slightly altered nature, they qualify for new patents, even though the underlying protein and mechanism of action in the body remains the same.

I don't find ad hominem attacks very useful. If you wish to point out something that is incorrect, then argue the point. I'd be curious to know why you think there is no such thing as a biogeneric.