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FDA to speed up approvals of generic biologic medicines as Trump targets high drug costs
U.S. Food and Drug Administration Commissioner Marty Makary speaks during a press conference alongside U.S. Secretary of Health and Human Services Robert F. Kennedy Jr., and Centers for Medicare & Medicaid Services Administrator Mehmet Oz, discussing administration plans to lower drug costs, at the Department of Health and Human Services in Washington, D.C., U.S., Oct. 29, 2025.
Annabelle Gordon | Reuters
The Food and Drug Administration on Wednesday said it will take steps to speed up the process of developing generic versions of complex biological drugs, in a bid to increase cheaper competition for expensive medicines and lower drug costs for Americans.
It’s the Trump administration’s latest move to rein in high prescription drug costs in the U.S., where medication prices are two-to-three times higher than those in other developed nations.
The move to support the development and approval of so-called biosimilars could be a blow to pharmaceutical companies, whose most profitable products are often biological products that treat serious and chronic diseases. The exact impact will depend on the drugmaker and its products.
In a statement on Wednesday, a Health and Human Services Department spokesperson said the law gives manufacturers 12 years of exclusivity for biologic medicines, which is a “primary determining factor in drug development decision-making.”
“No manufacturer should anticipate a monopoly or anything else beyond what is legally granted,” the spokesperson said.
The FDA’s new reforms “will take the five-to-eight year timeframe to bring a biosimilar to market and cut it in half,” the agency’s Commissioner Marty Makary said during a press conference on Wednesday.
During the event, HHS Secretary Robert F. Kennedy Jr. said the FDA has an “outdated and burdensome approval process that has slowed down the entry of biosimilars.” He said “even when [the drugs] do get approved, current laws often prevent pharmacists or patients from substituting them for patients who would benefit from a more affordable option.”
“That all ends today, a the FDA is taking bold, decisive action to break down these barriers and open the markets for real competition,” Kennedy said.
Biological products are engineered with living cells, which makes manufacturing more complex than for chemically derived drugs. Biologics have a special pathway to FDA approval, and it is harder for generic drug manufacturers to sell cheaper versions due to the high costs of development and difficult regulatory landscape.
Biologic medications make up only 5% of prescriptions in the U.S., but account for 51% of total drug spending as of 2024, according to an FDA release. FDA-approved biosimilars are as safe and effective as their branded counterparts, yet their market share remains below 20%, the agency added. The FDA said it has so far approved 76 biosimilars, making up only a small fraction of approved biologic drugs.
Kennedy said biosimilars, on average, cost half the price of their branded counterparts. Their entry into the market drives down brand-name drug prices by another 25%, which is a “real relief for patients,” he added.
Biosimilar generics saved $20 billion in U.S. health-care costs last year alone, the FDA said.
In a new draft guidance, the FDA proposed major updates to simplify biosimilar studies. For example, the agency recommended that human studies directly comparing the biosimilar to a branded product may not be necessary for drug companies to conduct. That research takes years and costs tens of millions of dollars.
Biosimilars have historically struggled to gain market share from their branded counterparts compared to generic copies of small-molecule drugs, which are often delivered in pill form and can enter cells easily because it has a low molecular weight.
The difference is that many biosimilars aren’t identical copies of branded biologic drugs, while generics are.
In many cases, pharmacists can’t directly substitute a branded biologic for a biosimilar when filling a prescription unless they are classified as “interchangeable” and it is permitted by state law.
But the FDA on Wednesday said it generally recommends against requiring so-called “switching studies,” which determine whether biosimilars have that classification. That step is not required for generic copies of small-molecule drugs.
“These additional studies can slow development and create public confusion about biosimilar safety,” the FDA said in a release.
Business
Panel questions IndiGo, DGCA babus, gets ‘unconvincing’ replies | India News – The Times of India
New Delhi: IndiGo was quizzed on Wednesday by a parliamentary committee over the misery inflicted on passengers by its mass-cancellation of flights, but it blamed a variety of factors, including system glitch and adverse weather conditions, while DGCA and the aviation ministry parried off criticism of their role in the fiasco.Some committee members termed replies of different stakeholders as “unconvincing” and aimed at washing their hands of the crisis, encapsulated by the response of a govt official that he first came to know of the unfolding ordeal through media reports.The panel, headed by JDU’s Sanjay Jha, decided to wait for the report of an inquiry ordered by DGCA before coming to a conclusion and make its recommendation. It will hold another meeting and is expected to call these stakeholders again. The DGCA-ordered committee was constituted on Dec 5 and was asked to submit its report in 15 days.Captain Sam Thomas, president of Bengaluru-based Airline Pilots Association of India, created flutter at the meeting by alleging corruption in DGCA and was asked by members to refrain from making sweeping allegations without producing evidence. He alleged that one can commit any wrong, but stay safe if he touched right feet.A committee member said IndiGo, which has offered apology for the ordeal, was far from apologetic in its response before the panel. It told the panel that several factors combined to derail its operation, including a glitch in system, which needed rebooting, and adverse weather that had their pilots stuck in different zones.IndiGo was represented by its COO Isidre Porqueras, while officials of Air India, Akasa Air, Spice Jet and Air India Express appeared before the panel as well. Civil aviation secretary Samir Kumar Sinha and top functionaries of other stakeholders were part of the deliberations.Replying to a query, IndiGo said all luggage, except 52 which remained unclaimed, have already been delivered.The panel’s meeting came against the backdrop of the suspicion, subject of investigation, that IndiGo remained resistant to the implementation of guidelines (Flight Duty Time Limitation) that allowed more rest for pilots in line with global norms aimed at ensuring flyers’ safety.It has been accused of engineering the disruption, leveraging its market dominance, to force the ministry to roll back the regulation as implementing it would have required the airline to hire more pilots. Faced with chaos caused triggered by disruption of IndiGo’s operations, DGCA had to relax the implementation of the guidelines.IndiGo management is reported to have denied allegation in meetings with ministry.
Business
Historic Green Milestone: Indian Railways Achieve 99.2% Electrification, Leaves UK, Russia And China Far Behind
New Delhi: Indian Railways has reached a milestone in its journey toward sustainable transportation, achieving electrification of 99.2 per cent of its broad gauge network. This puts India ahead of major rail economies such as the United Kingdom, which stands at 39%, Russia at 52% and China at 82%, according to a press release from the Ministry of Railways.
The achievement brings the country closer than ever to operating a fully electrified railway system. Fourteen railway zones, including Central, Eastern and Northern Railways, have already achieved 100% electrification. In addition, 25 states and union territories have completed electrification across their rail networks.
Data provided in a written reply to the Lok Sabha highlights the rapid pace of this transformation. Between 2014 and 2025, India electrified 46,900 route kilometres, more than double the 21,801 route kilometres completed in the previous six decades.
In the past two years alone, 7,188 route kilometres were electrified in 2023-24 and 2,701 route kilometres in 2024-25.
The environmental benefits of this transition are major. Rail transport emits 89% less CO2 than road transport, and Indian Railways is complementing electrification with renewable energy initiatives. So far, 898 MW of solar power has been commissioned at 2,626 stations, reinforcing India’s commitment to a greener transportation network.
Electrification is advancing consistently across zones. The Central, East Coast, East Central, Eastern, Konkan Railway, Kolkata Metro, North Central Railway, North Eastern Railway, Northern Railway, South Central Railway, South East Central Railway, South Eastern Railway, West Central Railway and Western Railway have achieved full electrification.
Other zones, such as North Western, Southern, Northeast Frontier and South Western Railway, have crossed 95% electrification.
The progress is equally impressive state-wise as well. Most states are fully electrified, while Rajasthan, Tamil Nadu and Karnataka are nearing completion. In the North Eastern region, the broad gauge networks in Arunachal Pradesh, Meghalaya, Nagaland, Tripura and Mizoram have been 100% electrified, while Assam stands at 92%, with work underway to complete the remaining sections.
All new rail lines and multi-tracking projects are now being sanctioned with electrification integrated from the beginning. According to the Ministry of Railways, the completion timeline for electrification projects depends on factors such as forest clearances, relocation of utilities, statutory approvals, geological and topographical conditions, law and order situations and climatic constraints, which can affect progress at different project sites.
Beyond expanding connectivity, electrification is central to India’s sustainability agenda. The move to electric rail corridors is helping dramatically cut carbon emissions. For instance, transporting 1 tonne of freight over 1 km emits 101 g of CO2 by road, compared with just 11.5 g by rail, an almost eightfold reduction.
The Indian Railways aims for 100% electrification while contributing to the nation’s goal of net-zero carbon emissions by 2030. Every new rail project now includes electrification from the outset, ensuring that India’s railway system grows greener, more efficient and globally competitive.
Business
Medical supply firm Medline jumps more than 30% in debut after biggest IPO of 2025
Shares of U.S. medical supplies giant Medline jumped more than 30% in its debut on the Nasdaq on Wednesday after the biggest initial public offering of the year globally.
The stock opened at $35, up from its $29 IPO price.
The private equity-owned company sold a little over 216 million shares on Tuesday, raising $6.26 billion in an upsized offering that finished off a strong year for new listings and bolstered optimism about the IPO market in 2026. Shares of Medline will trade under the symbol MDLN.
That IPO pricing gives Medline a market value of at least $37 billion, based on the shares listed in its regulatory filings.
“Historically, we’ve done very little advertising, very little marketing, and this gives us a way to amplify our voice and actually expand really the receptivity of who we are,” Medline CEO Jim Boyle told CNBC’s “Squawk Box” earlier Wednesday. “We are the largest company you’ve never heard of, and we happen to be everywhere. And that’s a really interesting thing.”
The U.S. IPO market has held steady despite market volatility in the spring, driven by President Donald Trump’s sweeping tariffs, and the longest U.S. government shutdown in history in the fall. Just over 200 IPOs have priced this year, including Medline, which is the largest U.S. listing since Rivian‘s $13.7 billion deal in November 2021, according to data compiled by CNBC.
But Medline’s IPO is also among the biggest private equity-backed listings. Three private equity firms — Blackstone, Carlyle and Hellman & Friedman — acquired a majority stake in the company in 2021 for a whopping $34 billion. At the time, the deal was the biggest leveraged buyout since the financial crisis.
CEO Jim Boyle celebrates with others as medical supplies giant Medline (MDLN) holds it’s IPO at the Nasdaq stock market site in Times Square in New York, Dec. 17, 2025.
Shannon Stapleton | Reuters
Medline, founded in 1966, is based in Northfield, Illinois. The company manufactures and distributes roughly 335,000 different medical and surgical supplies — from gloves, masks and scalpels to wheelchairs. Medline has customers in more than 100 countries and, as of the end of 2024, employed more than 43,000 workers worldwide.
Medline’s total debt was around $16.8 billion as of late September 2025. The company raked in $25.5 billion in net sales in 2024.
Medline’s earlier plans to go public this year were postponed due to uncertainty around tariffs affecting products from Asia. The majority of the company’s products are sourced or manufactured in Asian nations, particularly China.
Medline expects a $150 million to $200 million hit from tariffs to income before taxes in fiscal 2026.
The company competes with names like McKesson and Cardinal Health.
— CNBC’s Gina Francolla contributed to this report
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