Pricey biologics offer more promise than traditional drugs
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Kamal Rashid, director of the Biomanufacturing Education & Training Center at Worcester Polytechnic Institute
The cost of prescription drugs is a hot-button issue and an important public policy matter to consider. In doing so, it’s vital to understand the fundamental difference between traditional pharmaceuticals and the newer class of medicines called biologics.
Biologics are more complex and expensive to make, but they have a far greater capacity to treat serious diseases. That’s why biologics are beginning to dominate the industry’s R&D pipeline.
Traditional drugs like aspirin or statins that lower cholesterol are chemical formulations made directly by pharmaceutical companies. Biologics, like insulin or the revolutionary rheumatoid arthritis drug Humira (developed right here in Worcester) are made within living cells then harvested and purified. Think of it as the difference between baking cookies in your kitchen and growing tomatoes in your garden.
To bake cookies you mix the ingredients, portion out the dough and apply heat. If you follow the recipe precisely, you will get the same kind of cookies each time. To enjoy a ripe garden tomato, however, you must first establish a living organism (the plant) and rely on it to be the factory. You must nurture the plant’s growth, guard against pests and pathogens, feed and water appropriately, and over time, if all goes well, you will harvest an edible tomato.
When we extend this analogy to FDA approved medicines, imagine having to grow an acre’s worth of identical plants that all produce identical tomatoes. To succeed, you must monitor and control every element of the environment that affects the plants’ growth. Then you must verify that every tomato you harvest is identical to the approved strain and is free of contamination.
Biologic drug makers use genetically engineered cells as the factories to make a specific therapeutic protein which is then harvested and purified. At every step of the process, from research and development, to scaling up from a single cell to full scale production, biologics are far more complicated, require more process steps and environmental controls, and are therefore more expensive to bring to market. Studies show it can take $1 billion and up to 10 years of development and clinical testing to get a new biologic approved by the FDA.
Given their cost and complexity, why are biologics the fastest growing segment of the drug development pipeline? The answer is simple: they can treat more diseases, in different ways, and more effectively than is possible with traditional pharmaceuticals. Over time, technology advances will help lower the cost of biologics to some degree. The latest trend, which we are incorporating in our biomanufacturing training programs at Worcester Polytechnic Institute, is single-use technologies in the manufacturing platform rather than more expensive stainless steel equipment. This removes some costs for manufacturers and enables creating smaller batches of drugs for targeted populations in a more economical way.
Every day we learn more about specific molecules in our bodies that cause disease. Nearly all of those molecules are untouchable by traditional pharmaceuticals, but all are potentially reachable with biologics. Diseases caused by the lack of a vital molecule (think Type 1 diabetes) can be treated with biologic replacement therapy.
We are at the beginning of a biologics revolution in medicine. To take full advantage of the emerging science and develop better treatments for cancer, Alzheimer’s disease and many other serious conditions, then we have to understand the economics of biologics and invest in the technology that brings these life-saving medicines to people.
Kamal Rashid, PhD, is a research professor and director of the Biomanufacturing Education & Training Center at Worcester Polytechnic Institute.
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