Lowering the prices of prescription drugs has been high on United States President Donald Trump\u2019s agenda since he took office in January. He has taken a number of steps, including striking deals with pharmaceutical companies, to lower the costs of prescription drugs.<\/p>\n
Trump has also directed the Food and Drug Administration (FDA) to streamline its regulation process to boost cheaper copycat drugs, such as generic and biosimilar drugs.<\/p>\n
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Biosimilars are highly similar versions of biologics, a group of drugs produced through biological processes. One of the most widely used biologic drugs is insulin, which is used to treat diabetes.<\/p>\n
Biologics, which make up just 5 percent of prescriptions, account for more than half of the total expenditures on medicines in the US, according to the health data analysis company IQVIA.<\/p>\n
The Trump administration said it\u00a0hopes\u00a0to make these medications more affordable<\/a>, partly by increasing access to biosimilars.<\/p>\n So what are biologics and biosimilars, and will the administration\u2019s proposals help drive down their costs<\/a>?<\/p>\n What are biologics?<\/p>\n Biologics is short for biological medications or products. It\u2019s a broad category of products that include vaccines, blood and blood components, gene therapy and tissues. They are a class of complex drugs produced through biological processes or from living organisms, such as proteins and genes. They treat cancer, autoimmune diseases and other rare disorders.<\/p>\n Biologics are typically administered by injection or through an intravenous infusion, said Alex Keeton, executive director of the Biosimilars Council at the Association for Accessible Medicines, an industry group that advocates on behalf of biosimilar manufacturers.<\/p>\n The FDA approval process for these products is rigorous and typically takes 10 to 15 years, said Brian Chen, a University of South Carolina health law and economics expert. Speedier timelines are possible in extraordinary circumstances: Federal agencies worked with vaccine manufacturers and scientists to\u00a0expedite COVID-19<\/a> vaccines, for example.<\/p>\n What are biosimilars?<\/p>\n As the name suggests, these medications are similar to the original biologics approved by the FDA. Biosimilars are developed and sold after the original biologic has lost its patent exclusivity, Keeton said. Biosimilars for Humira, a drug used by people with rheumatoid arthritis, include Cyltezo, Amjevita and Idacio.<\/p>\n \u201cThey still work the same way clinically, but they\u2019re not exactly the same,\u201d Keeton said.<\/p>\n That\u2019s because, unlike with generic versions of brand name drugs, it\u2019s impossible to make exact copies of biologics. Biologics have complicated production processes and their\u00a0components\u00a0are derived from live organisms.<\/p>\n \u201cBiologics are like strands of flexible, cooked spaghetti folded in very specific ways, making exact replication nearly impossible,\u201d Chen said.<\/p>\n The FDA evaluates proposed biosimilar products against the original biologic to determine whether the product is extremely similar and has no meaningful clinical differences. It is expected to have the same benefits and risks as the original biologic. To be approved, biosimilar manufacturers must show patients using their products don\u2019t have new or worsening side effects compared with patients using the original biologic.<\/p>\n FDA approval for biosimilars often takes five to six years, Keeton said.<\/p>\n