Why are biologic medicine costly? Will Trump’s plans make them cheaper? | Donald Trump News | USAEMALL.com

Lowering the prices of prescription drugs has been high on United States President Donald Trump’s 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.

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.

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.

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.

The Trump administration said it hopes to make these medications more affordable, partly by increasing access to biosimilars.

So what are biologics and biosimilars, and will the administration’s proposals help drive down their costs?

What are biologics?

Biologics is short for biological medications or products. It’s 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.

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.

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 expedite COVID-19 vaccines, for example.

What are biosimilars?

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.

“They still work the same way clinically, but they’re not exactly the same,” Keeton said.

That’s because, unlike with generic versions of brand name drugs, it’s impossible to make exact copies of biologics. Biologics have complicated production processes and their components are derived from live organisms.

“Biologics are like strands of flexible, cooked spaghetti folded in very specific ways, making exact replication nearly impossible,” Chen said.

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’t have new or worsening side effects compared with patients using the original biologic.

FDA approval for biosimilars often takes five to six years, Keeton said.

Biosimilars increase market competition, incentivising brand name drug manufacturers to lower their prices.

How much do biologics and biosimilars usually cost?

They’re pricey, and exact costs vary.

One 2018 study found that biologics and biosimilars can cost a US patient $10,000 to $30,000 each year on average.

Humira is more. It was listed at $6,922 for a month’s supply in early November. The Humira biosimilar Cyltezo advertises for 5 percent off Humira’s cost. The makers of Cyltezo also offer a non-brand name option for people who pay cash at pharmacies while using the GoodRx app at a price of $550.

The actual amount insured patients pay also depends on their plan and their insurer’s negotiated rates.

Biosimilar prices typically run 15 percent to 35 percent lower than their brand name biologic counterparts, one 2024 study found. The FDA found biologics produce a more dramatic cost savings of 50 percent on average.

Why are these medications so expensive?

Biologics and biosimilars are difficult to develop and produce, which adds to their expense.

Making a standard over-the-counter medication such as aspirin requires five ingredients. Making insulin, a biologic, requires genetic modifications to living organisms.

These complex manufacturing procedures and proprietary information make it difficult for competitors to create alternatives.

To put this in perspective, there were 226 marketed biologics in the US as of July, and the FDA had approved 76 biosimilars such as insulin. When it comes to non-biologic medications, the FDA has approved more than 32,000 generic drugs. That’s more than the number of approved brand name drugs.

Can biosimilars be used in place of the original, FDA-approved biologics?

Yes. All biosimilars must meet FDA requirements and must be highly similar and have no clinically meaningful differences from their existing FDA-approved biologic counterpart.

So how does the Trump administration hope to change the FDA approval process for biosimilars?

Under its draft guidance, the administration proposed reducing some of the tests required as part of the FDA process used to prove a biosimilar drug is as safe and effective as its biologic counterpart.

Currently, a manufacturer requesting a biosimilar licence has to provide clinical study data proving its product’s similarity. The FDA’s new proposal would no longer require drug developers to conduct these comparative clinical trials.

Manufacturers would still be required to test proposed biosimilars. Other data – including comparative analysis, immune response data and human study data showing how the drug moves through the body – could sufficiently demonstrate the drug’s similarity to an existing biologic, the FDA said.

Why does the FDA want to change the biosimilar approval process?

Ultimately, the agency said it aims to incentivise drug manufacturers to quickly develop biosimilars by eliminating redundant, costly and time-consuming clinical studies, Keeton said.

Saving that time might increase the number of biosimilar alternatives.

It would almost certainly lower the front-end development costs for drugmakers, Chen said.

Will that change lower the costs of these medications for patients who need them?

Regulatory changes alone may not significantly drive down prices for many Americans.

Several non-brand name options need to be available to produce significant price drops, according to a US Department of Health and Human Services report.

But prices could remain the same even with more options.

A 2024 study in the JAMA Health Forum, a health policy journal, found that annual out-of-pocket costs either increased or remained stable for most biologics even after biosimilars were available. Patients who used biosimilars didn’t pay less than those who used the original biologics.

That’s at least partly because biologic manufacturers often offer substantial rebates to pharmacy benefit managers, companies that work with insurers, employers and others to manage prescription drug plan benefits. In exchange, insurers give the name brand biologics preferred or exclusive placement on their lists of insurance-covered drugs, Chen said. Rebate walls ultimately prevent the sale of cheaper biosimilars, he said.

Are there any other obstacles to getting more biosimilars on the market?

Yes, another key hurdle remains: Name brand biologic manufacturers often hold many patents and file lawsuits blocking approved biosimilars from being commercially marketed.

A 2018 study conducted by Chen found that of 12 FDA-approved biosimilar products, five were commercially available as of October 2018. Six others were unavailable because of patent disputes.

PolitiFact researcher Caryn Baird contributed to this report.