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 said the FDA has an “outdated and burdensome approval process that has slowed down the entry of biosimilars.”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.
Gold and silver prices have continued to drop sharply in a “brutal” sell-off after hitting record highs in recent weeks.
The precious metals began falling on Friday in response to US President Donald Trump’s nomination for the incoming chairman of the Federal Reserve.
His choice for former Fed governor Kevin Warsh to replace current chairman Jerome Powell when his term ends in May soothed some investor nerves, which boosted the US dollar but saw appetite for safe-haven investments gold and silver slump in response.
Gold and silver suffered their worst trading days for decades on Friday and were down heavily again on Monday, with spot prices off by another 7% and 11% respectively at one stage.
Silver had plunged by nearly 30% on Friday and gold dropped over 9% in its worst one-day drop since 1983.
Gold and silver had been enjoying a record breaking rally as investors sought refuge amid global geopolitical uncertainty, conflict and tariff woes.
Ipek Ozkardeskaya, senior analyst at Swissquote, said: “The sell-off has been far more brutal than I, and many, expected.”
He added: “For silver, the rally on the way up was faster than gold’s, so the correction on the way down is faster too.”
Kathleen Brooks, research director at XTB, added: “If the sell off continues, then gold and silver are at risk of eroding their losses for the year so far.
“The historic move lower in silver prices has not stemmed a fall at the start of this week.
“Traders have not yet found a level that they are happy to buy the dips, and the timing of Chinese Lunar New Year in mid-February could accelerate the sell off, as Chinese traders reduce risk ahead of the holiday.”
UK and US stock markets are expected to open in the red on Monday, as the gold and silver rout has a knock on effect on mining giants, while Brent oil was also 5% lower.
Derren Nathan, head of equity research at Hargreaves Lansdown, said: “Mining stocks are likely to feel the heat as metal prices scramble to find a floor.
“Oil prices are also trending the wrong way for investors in commodity-focused companies.”
Mumbai: Lower revenue as a share of GDP has been more than offset by cuts to subsidies and spending on current schemes, leading to the smallest fiscal consolidation in six years, likely positive for growth, a new report has said.
The fiscal consolidation for FY27 is the slowest in six years. And the budgeted disinvestment, which is a below-the-line funding item, is likely to see the highest rise in six years, the report from HSBC Global Investment Research said.
“The central government continues with fiscal consolidation, though signing up for a gentler path for FY27; the fiscal impulse will likely turn neutral after several years in the negative, and this should be good news for GDP growth,” the research firm added.
The report said that the services sector was the focus of the Budget, “with ambitious plans and increased outlays for medical institutions, universities, tourism, sports facilities, and the creative economy.”
Urban infrastructure saw a renewed push with each City Economic Region (CER) set to receive get Rs 50 billion over 5 years.
Seven new high-speed rail corridors will connect major cities, the report noted, adding large cities will also get an incentive of Rs 1 billion if they issue municipal bonds worth more than Rs 10 billion.
The report highlighted policy priorities, saying, “new manufacturing sectors were given incentives, namely biopharma, semiconductors, electronic components, rare earth corridors, chemical parks, container manufacturing, and high-tech tool rooms.”
Direct taxes are expected to grow faster than nominal GDP while indirect taxes will expand more slowly, with gross tax revenues budgeted to rise about 8 per cent year‑on‑year, the report said.
Central government set a fiscal deficit target of 4.3 per cent of GDP for FY27 after a 4.4 per cent estimate for FY26, and nominal GDP growth was pegged at 10 per cent.
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.
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