Demand for these new drug types stem from innovations in monoclonal antibodies, cell and gene science, oncology, and neurological treatments like Alzheimer’s drugs, alongside the biosimilar adoption of those biologics. In layman’s terms, a biosimilar is to a biologic, what a generic drug is to a patented drug; only a generic drug is a replica, and the biosimilar is only similar, not a replicant. Many U.S.-based pharmaceutical companies are in this segment of the market.
The U.S. biologics market is forecasted to exceed $300 billion by 2030 at a 7.7% growth rate, fueled by over 900 molecules in clinical pipelines and R&D capital. Pharma companies generally reinvest about 23% of their domestic sales to research new medicines. Most of the jobs in the biologics segment of pharma are in California, North Carolina, and Massachusetts.
Senate HELP Chairman Bill Cassidy (R-LA) – a physician who practiced in the field of gastroenterology – was the biggest proponent of biologics and biosimilars, and was looking for ways to bring them to market faster. He compared biosimilars to generic drugs, saying that if we could get more of those out there to the public, the cost of medicine would fall. Biologics are some of the most expensive medications around.
“Some 90% of all drugs dispensed in the U.S. are generics and they are affordable,” he said. The theme of the hearing was on the high cost of medication. He promptly noted that American generics are cheap, adding that 2024 generics generated an estimated $450 billion in healthcare savings.
“No other country has a generic system that works as well as ours. No other system develops as many new cures as the U.S., but the cures can be expensive and stretch, or be beyond the budget of many families,” he said.
Ryan Long, Director of Congressional Relations and a Senior Research Fellow at Paragon Health Institute [Testimony] said the medical system only gets low cost generics and biosimilars if we can keep making new and successful medicines. That brought him to the argument of the U.S. needing to preserve a biotech ecosystem, something China excels at.
“You have to preserve the innovation ecosystem while allowing for robust, generic and biosimilar competition,” he said. “Even though 90% of all prescriptions are generics, they represent only 12% of total drug spending. The biosimilar market will also bring savings.”
The hearing was mostly centered on making medicine more affordable. Members never said that generic drug affordability was due to imports. The high cost of drugs was mostly blamed on branded drugs, which are made domestically and imported from Europe primarily. These patented drugs are one of the biggest sources of the goods trade deficit on a monthly basis.
Solutions offered to the rising cost were mostly changes to how the FDA allows for biosimilars to enter the market, along with changes to Medicare rules.
Medicare Part D was highlighted as problematic by witness Ryan Long, namely because of what pharmaceutical companies call the “rebate trap.” To gain placement on a pharmacy benefit manager’s (PBM) formulary – the list of drugs insurance will pay for – manufacturers must offer rebates. PBMs and health insurers prefer products with high list prices and generous rebates because rebates generate revenue for the middlemen. A biosimilar with a genuinely low list price cannot offer a large enough rebate if they want to compete with a high-price biologic that can offer 50% rebates. Generic drugs do not face the same obstacles because of specific generic formulary tiers. This could change over time as this is still a developing market.
Congress still seems to be in the early innings of understanding this burgeoning market.
The biosimilar pipeline has expanded substantially. Since the first approval (Zarxio by Sandoz) in 2015, the FDA has approved 90 biosimilars. In 2025, the FDA approved 18 biosimilars for multiple reference products, including new product classes.
Warnings Of China Taking Lead In Biopharma Future In Latest Senate Hearing
If there is one thing that can be assured in a hearing involving a global business, it is that someone will bring up China’s role in it. Their role is always on the cusp of eating America’s lunch.
“China wants to dominate the life sciences industry as part of their five-year plan,” Brian J. Miller, MD, an Associate Professor of Medicine at Johns Hopkins University School of Medicine told the Senate Health, Education, Labor and Pensions (HELP) Committee on April 16 [Testimony].
Miller offered a contrast between the U.S. and China, issuing warnings of their seriousness in growing the biopharmaceuticals market and what he believed was their potential for abuse and foul play. “They want to spend 2.5% of their GDP on life sciences R&D. And they have their Thousand Talents program to attempt to capture our intellectual knowledge and people. They do not respect human rights in clinical trials experimenting on humans in labor camps. We respect human rights,” he said.
Miller, who was one of three witnesses in the hearing about the cost of making drugs, was asked what the Food and Drug Administration could do to help local pharmaceutical companies.
He suggested Congress transition the FDA to focus on standardizing initial analysis of new medicines and to “serve as a counselor and guide to product developers,” he said. “We are going to lose American dominance in the life sciences industry to China. This is the same industrial policy that China uses to take over other markets. Last year, 42% of new drug licensing deals came from China.”
CPA hit on this topic last October in a report titled The New Biotech Cold War.
In 2020, during the pandemic, some 23 companies in the biopharma space listed their shares on Chinese exchanges. By 2021, they had a roughly $380 billion market cap. Due to regulation arbitrage, and the usual issues – cost of bringing new drugs to market via R&D and trials, which is where China comes in as a solution provider for American labs – Miller says what many other China-watchers have said: China will dominate product development, new drug classes, and new innovations in the biologics and biosimilars segments will come from China.
“They have a supply chain chokehold on us with the rare earth minerals; we do not want to replicate that in the pharmaceutical industry,” Miller said. “We could lose this industry.”
The U.S. pharmaceutical industry employed about 1.3 million people in pharmaceutical and biotech labs and related industry roles in 2022.
Biologics and biosimilars represent the biggest growth sector in the global pharmaceuticals market. Multiple market analyses confirm they are projected to achieve the fastest compound annual growth rate through 2035, outpacing small-molecule conventional drugs – both the branded ones and generics – which hold the majority revenue share at around 57% as of 2025.
China holds a rapidly expanding position in the global biologics and biosimilars market, driven by heavy government support, regulatory reforms, and massive investments in biotech hubs like Shanghai and Suzhou. They still trail the U.S. and Europe in total market size, but are already a well-regarded R&D and clinical trials partner and are now seen emerging as an innovator, particularly in oncology drugs like monoclonal antibody-drugs.
Demand for these new drug types stem from innovations in monoclonal antibodies, cell and gene science, oncology, and neurological treatments like Alzheimer’s drugs, alongside the biosimilar adoption of those biologics. In layman’s terms, a biosimilar is to a biologic, what a generic drug is to a patented drug; only a generic drug is a replica, and the biosimilar is only similar, not a replicant. Many U.S.-based pharmaceutical companies are in this segment of the market.
The U.S. biologics market is forecasted to exceed $300 billion by 2030 at a 7.7% growth rate, fueled by over 900 molecules in clinical pipelines and R&D capital. Pharma companies generally reinvest about 23% of their domestic sales to research new medicines. Most of the jobs in the biologics segment of pharma are in California, North Carolina, and Massachusetts.
Senate HELP Chairman Bill Cassidy (R-LA) – a physician who practiced in the field of gastroenterology – was the biggest proponent of biologics and biosimilars, and was looking for ways to bring them to market faster. He compared biosimilars to generic drugs, saying that if we could get more of those out there to the public, the cost of medicine would fall. Biologics are some of the most expensive medications around.
“Some 90% of all drugs dispensed in the U.S. are generics and they are affordable,” he said. The theme of the hearing was on the high cost of medication. He promptly noted that American generics are cheap, adding that 2024 generics generated an estimated $450 billion in healthcare savings.
“No other country has a generic system that works as well as ours. No other system develops as many new cures as the U.S., but the cures can be expensive and stretch, or be beyond the budget of many families,” he said.
Ryan Long, Director of Congressional Relations and a Senior Research Fellow at Paragon Health Institute [Testimony] said the medical system only gets low cost generics and biosimilars if we can keep making new and successful medicines. That brought him to the argument of the U.S. needing to preserve a biotech ecosystem, something China excels at.
“You have to preserve the innovation ecosystem while allowing for robust, generic and biosimilar competition,” he said. “Even though 90% of all prescriptions are generics, they represent only 12% of total drug spending. The biosimilar market will also bring savings.”
The hearing was mostly centered on making medicine more affordable. Members never said that generic drug affordability was due to imports. The high cost of drugs was mostly blamed on branded drugs, which are made domestically and imported from Europe primarily. These patented drugs are one of the biggest sources of the goods trade deficit on a monthly basis.
Solutions offered to the rising cost were mostly changes to how the FDA allows for biosimilars to enter the market, along with changes to Medicare rules.
Medicare Part D was highlighted as problematic by witness Ryan Long, namely because of what pharmaceutical companies call the “rebate trap.” To gain placement on a pharmacy benefit manager’s (PBM) formulary – the list of drugs insurance will pay for – manufacturers must offer rebates. PBMs and health insurers prefer products with high list prices and generous rebates because rebates generate revenue for the middlemen. A biosimilar with a genuinely low list price cannot offer a large enough rebate if they want to compete with a high-price biologic that can offer 50% rebates. Generic drugs do not face the same obstacles because of specific generic formulary tiers. This could change over time as this is still a developing market.
Congress still seems to be in the early innings of understanding this burgeoning market.
The biosimilar pipeline has expanded substantially. Since the first approval (Zarxio by Sandoz) in 2015, the FDA has approved 90 biosimilars. In 2025, the FDA approved 18 biosimilars for multiple reference products, including new product classes.
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