Femi Olawuyi is a graduate student of Biotechnology Department, University of Maryland University College (UMUC), Md, and an AAPS graduate student member.
The debate between brand-name biomedicines versus biogeneric follow-on drugs or biosimilars is a hot topic in which bioethics play an undeniably vital role.
In my opinion, under the newly-implemented Patient Protection and Affordable Care Act (PPACA), all arguments that support establishing a simplified regulatory pathway to approve the production of less-expensive biosimilars are valid. The competition from biosimilars in a market dominated by brand-name drugs will prove to be a lucrative accomplishment not only for American consumers but also for health insurers. While the manufacturers of original medicines may suffer in profit and obtaining funds for future research and development, a major benefit of the new regulation will be a significant reduction in the cost of medicines and health care.
The Hatch-Waxman Act of 1984 encouraged the manufacture of “small molecule” generic drugs such as those used to commonly control diabetes, blood pressure, cholesterol, and pain. Owing to the resounding success of that legislation, in 2011 alone, almost 80% of prescribed drugs were generic, which saved consumers $193 billion on medicines. Biosimilars, such as monoclonal antibodies and therapeutic proteins, have a similar potential to save not only additional billions but also the lives of many patients who cannot afford expensive brand-name drugs.
However, there is a safety concern associated with the likelihood of using low-quality raw materials in the production of biogenerics with an aim to make them less expensive and more affordable to the consumer market. The concern is somewhat mitigated by the assertions made by Carole Ben-Maimon on safety issues in the production of biogenerics. According to Ben-Maimon, the availability of raw materials for producing biogenerics along with reliable “regulatory oversight” will tend to any overarching safety concerns.
Rob Garnick makes an important point that the government should be concerned about oversimplifying the production of biogeneric drugs. Most supporters would disagree with the major pivot of his assertion that an approval pathway for biogenerics will only thrive at the expense of safety and efficacy. Like the production of the original drug, the approval processes and production of biogenerics will be undoubtedly regulated by carrying out rigorous safety and efficacy tests and employing quality control measures to ensure that the biosimilar parallels the original drug.
Agreeing with the concerns of experts, the European Medicines Agency has already developed rigorous safety and efficacy guidelines for producing biosimilars in Europe. While biogenerics will reduce healthcare costs, increase competition in the pharmaceutical industry, and save the lives of many patients, those who support biogenerics should not forget that their production may hamper scientific innovation. Garnick asserts that innovators may be truly discouraged to invest in drug discovery and development owing to the disincentive that may be created by the presence of less expensive biogenerics in the market.
Another point relevant to the subject is the concept of “supergenerics” which sounds similar to biogenerics although it’s not the same. Supergenerics are original biomedicines with a “tweaked” formulation, mode of delivery, and sometimes even efficacy but they may not derive benefit of huge reductions in health care costs like biogenerics. On the other hand, the impending boom in biogeneric development will likely be immensely beneficial to consumers.
Do you support or reject the abbreviated licensure pathway for biosimilars under the Affordable Care Act?