Business
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 said the FDA has an “outdated and burdensome approval process that has slowed down the entry of biosimilars.”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
India’s $5 trillion economy push: How ‘C+1’ strategy could turn country into world’s factory
New Delhi: India is preparing for a major economic transformation. The Union Budget 2026-27 lays out measures that could make the country the top choice for global manufacturing using the popular ‘China +1’ (C+1) strategy. This comes as international companies rethink supply chains after COVID-19 disruptions, rising trade tariffs and geopolitical tensions.
India has positioned itself as the backup factory for the world that is ready to absorb international demand in case of any crisis in China or Taiwan.
The government has offered tax breaks for cell phone, laptop, and semiconductor makers, making India more attractive to foreign investors. Reducing bureaucratic hurdles for global firms, the budget also strengthens the National Single Window System to simplify business procedures. The message is clear: India is ready to step in as a global manufacturing hub, ensuring supply continuity for the world.
The expressway to a $5 trillion economy
China presently dominates about 40% of global manufacturing. Its factories supply critical products worldwide, but 2026 is expected to be a turning point. Expanding influence and economic opacity have made global companies seek alternatives.
India has leveraged this moment, offering a comprehensive incentive package for foreign manufacturers. Analysts call it more than policy; it is a blueprint to become a $5 trillion economy and reclaim India’s historic position as a global industrial leader.
Why the world needs India now
The COVID-19 pandemic exposed the dangers of over-reliance on a single supplier. When China halted medical exports, nations realised the need for diversified supply chains. Major companies such as Apple and Samsung now see India as a dependable alternative.
China’s aging workforce and rising labour costs further enhance India’s appeal. With 65% of its population under 35, India offers a vast, skilled and affordable workforce for decades. The geopolitical uncertainty surrounding Taiwan, which produces 90% of advanced chips, has also created demand for a secure manufacturing backup. India is stepping in to fill that gap.
How India stands to gain from China’s challenges
India’s budget, 2026-27, slashes import duties on cell phone and laptop components, turning the country into a hub for component manufacturing, not just assembly. Electronics exports are projected to cross $120 billion by 2025.
The government has also launched a Rs 1.5 lakh crore semiconductor mission, attracting companies like Tata and Micron to establish advanced chip plants in India. In the chemical sector, stricter environmental regulations in China have shut down several plants, benefiting Indian companies such as Privi Specialty and Aarti Industries, which are now filling gaps in global supply chains.
Incentives for companies
The Production Linked Incentive (PLI) scheme promises cash rewards for output, covering over 14 sectors. This is India’s answer to Chinese subsidies. From land acquisition to electricity connections, the National Single Window System now enables businesses to clear all approvals through a single portal.
Infrastructure investment has also received a massive boost, with Rs 11.11 lakh crore allocated under PM GatiShakti. New ports and dedicated freight corridors are being built to ensure that exports from India reach the world faster and cheaper than ever before.
India’s moves points to a strategic shift in global manufacturing. By rolling out the red carpet for foreign companies and investing heavily in infrastructure, technology and policy reforms, the country is poised to become the go-to destination for global supply chains. The C+1 formula is not only a concept; it is a roadmap to turn India into the next industrial superpower and a $5 trillion economy.
At a time when global markets are witnessing high volatility due to geopolitical uncertainties, the hike in securities transaction tax (STT) on derivatives trades hit investor sentiment on Dalal Street on the Budget day. This in turn led to a sharp sell-off that pulled the sensex down by nearly 1,500 points—its biggest points loss on a Budget day—to close at 80,773 points. The sell-off also left investors poorer by Rs 9.4 lakh crore, the biggest Budget day loss in BSE’s market capitalisation.The day’s trading was marked by high volatility. The sensex rallied over 400 points as FM started her speech, fell about 1,100 points after the STT hike proposal was announced, partially recovered by mid-session to trade 600 points down on the day and then sold-off to close below the 81K mark for the first time in four months.On the NSE, Nifty too treaded a similar path to close 495 points (2%) lower at 24,825 points. Fund managers and market players feel the day’s sell-off was overdone, compounded by the absence of most institutional players since it was a Sunday. “The market’s reaction (to the hike in STT rates) was a bit overdone, although the decision itself was unexpected,” said Taher Badshah, President & Chief Investment Officer, Invesco Mutual Fund. “I think markets should settle down in 2-3 days.” Badshah said the Budget was in line with govt’s set path of the past few years, showing a conservative approach to setting targets.“The revenue and expenditure targets for FY27 are achievable. And since the rate of inflation is lower now, the nominal GDP growth rate of 10% may turn out to be on the higher side as inflation normalises during the year,” the top fund manager said. In Sunday’s market, of the 30 sensex stocks, 26 closed in the red. Among index constituents, Reliance Industries, SBI and ICICI Bank contributed the most to the day’s loss. Buying in software services majors Infosys and TCS cushioned the slide. In all, 2,444 stocks closed in the red compared to 1,699 that closed in the green, BSE data showed.STT hike aimed at curbing F&O speculation The decision to raise securities transaction tax (STT) for trading in equity derivatives means trading futures & options (F&O) will be more expensive from April 1. STT on futures trading rises from 0.02% to 0.05% now, and on options premium and exercise of options to 0.15% from 0.1% and 0.125% respectively. This could more than double statutory costs of trading F&O contracts.While the move is to curb excessive speculation by retail traders who mostly suffer losses, investors sold stocks of those companies that derive a large portion of their turnover from this segment. Stock price of Angel One crashed nearly 9%, BSE crashed 8.1%, Billionbrains Garage Ventures that runs the Groww trading platform, lost 5.1% and Nuvama Wealth Management lost 7.3%. STT hike follows a Sebi survey that showed that 91% of the retail investors lost money in the F&O market with average loss per investor surpassing Rs 1 lakh per year. Institutional and some high net worth players took home most of the profits from the segment.18% GST on brokerage for FPIs removedThe Budget proposed to do away with 18% GST charged on the brokerage that foreign portfolio investors pay in India. Among the host of changes to the GST laws that the finance minister proposed, one was abolishing clause (b) of sub-section (8) of section 13 of the Integrated Goods and Services Tax Act, 2017. This is being “omitted so as to provide that the place of supply for ‘intermediary services’ will be determined as per the default provision under section 13(2) of the IGST Act,” the Budget proposal said.
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