Biologics Controversies
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Proving Safety and Efficacy
With biologics, controversy mostly lies within whether or not clinical trials should be performed and, if the trial process can be bypassed with the safety of these products. Since biologics are large molecular drugs, they are regulated by the Public Health Service Act (PHSA) under section 351 rather than the FDCA, the Food, Drug, and Cosmetic Act. “Under the PHSA, all biologics require full clinical studies to show that they are safe, pure, and effective. Under the FDCA, major barriers are reduced and generic manufacturers can get copies of medicines to market much easier.” So instead of proving safety and effectiveness through clinical trials, a generic manufacturer will need to show only that its product is bioequivalent to a pioneer product and the FDA could, therefore, rely on the pioneer’s safety and efficacy data to determine the potentials of the copy. But there is no abbreviated approval pathway for products licensed under the PHSA.
Biologics are large molecular drugs that are rather different from pharmaceuticals, which are small molecular drugs. Biologics are manufactured in a living system most likely produced with recombinant DNA technology. On the other hand, pharmaceuticals are normally manufactured in an ordered process through chemical synthesis. They are different in that biologics are more complex, and the finished product is unable to be characterized and labeled in the laboratory. . The living systems used to produce biologics can also be sensitive to minor changes in the manufacturing process. The FDA’s concerns are based on this information and, therefore, the agency are composing and releasing new drug applications for biologics. Overall, in most instances, clinical trials are required for those companies seeking approval for biologics. And as more and more biologics are produced, a new question arises, What is ‘sameness’ and how would it be measured?
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Cost Considerations
Another one of the controversies regarding biologics is their cost. For example: one year’s worth of Herceptin, a breast cancer-fighting biologic antibody, costs more than $40,000. And one year’s supply of Cerezyme, used to Gaucher disease, a rare disorder, is known to cost more than $150,000. It is claimed by advocacy groups that consumers could save up to $1 billion a year if cheaper, generic-type biologics known as biosimilars were used.
“The pharmaceutical industry notes that the steep cost of developing an innovator biologic ($1.2 billion) and the lengthy time it takes a manufacturer to jump through the research, clinical testing and approval process (roughly ten years) warrants strong patent and patient protections. The American Association of Retired People (AARP) and other advocacy groups challenge those R&D figures. But there is no question that developing these treatments is costly, with many failures leading to a relative handful of well-rewarded successes.” Time and expense are two of the most important factors of drug development. Governments and consumers alike support the use of biosimilars, because of its low cost coupled with their use. All over the world, biologics account for one out of eight prescriptions written. They are used to treat multiple sclerosis, diabetes, rheumatoid arthritis, and cancer. Biologics account for more than 16% of the total drug expenditure in the United States.
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