Biopharmaceuticals, or BioPharma, are medical products that are derived from biological sources and made using biotechnology. They can come from sugars, nucleic acids and proteins.
The first biopharmaceutical produced was recombinant human insulin (rHI), made by Eli Lilly in 1982. Biopharmaceuticals are becoming more widely used because of their efficacy in treating cancers and metabolic diseases.
Advantages of biopharmaceuticals include their ability to target very specific molecules, leading to fewer side effects. Also, they work with high specificity and activity, making them very effective in patients who do not respond well to more traditional drugs.
Biopharmaceuticals are differentiated from synthetic drugs in their production; biopharmaceuticals are produced using products extracted from natural sources and sometimes use the innate biological mechanisms inside organisms to synthesize these products.
Biopharmaceuticals are notably very expensive to produce. Large-scale production can cost anywhere from $200 million to $500 million. Considering the amount of money that goes into producing biopharmaceuticals, the price of these products can skyrocket.
A major aspect of the BioPharma industry is the patenting process, which can allow the producer of a certain drug to recover some of their investment. Additionally, the Food and Drug Administration (FDA) approves and oversees the commercial distribution of biopharmaceuticals, meaning that there is some strict oversight on the efficacy of a drug.
Currently, biopharmaceuticals make up about 20 percent of the pharmaceutical market, a statistic that continues to grow. BioPharma is not a new part of the pharmaceutical industry, but it is a part that continues to expand rapidly.
There is limited federal oversight on the pricing of these drugs beyond the scope of the FDA, but the technological advancements and breakthroughs that have been part of this expansion seem to warrant high prices to some. As this industry continues to grow, federal oversight might become more and more relevant.
Sahiti R. Karnati was a Healthcare intern for ONC during the Spring 2022 semester.
Sources:
Kesik-Brodacka, Malgorzata. “Progress in Biopharmaceutical Development.” Biotechnology and Applied Biochemistry, John Wiley and Sons Inc., May 2018, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6749944/.
“What Is Biopharmaceutical?” What Is Biopharmaceutical?, BioProcess Online, https://www.bioprocessonline.com/doc/what-is-biopharmaceutical-0001.
Otto, Ralf, et al. “Rapid Growth in Biopharma: Challenges and Opportunities.” McKinsey & Company, McKinsey & Company, 28 July 2021, https://www.mckinsey.com/industries/life-sciences/our-insights/rapid-growth-in-biopharma.
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