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 said the FDA has an “outdated and burdensome approval process that has slowed down the entry of biosimilars.”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
Bhavish Aggarwal Partially Sells Ola Electric Stake After Stock Slump; Analysts Flag Weak Fundamentals
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Ola Electric Share Price: Exchange filings show Aggarwal sold about 2.6 cr shares via bulk deal, resulting in reduction in his shareholding
Ola Electric Share Price.
Ola Electric Share Price: The sharp decline in Ola Electric Mobility Ltd’s share price may have prompted founder Bhavish Aggarwal to sell a portion of his stake, with analysts noting that the company’s weak operating performance continues to offer little support to the stock.
Shares of the electric two-wheeler maker are trading at a record low of around Rs 35, down more than 50 percent from the issue price of Rs 76 and sharply lower from a peak of about Rs 150. The stock has fallen nearly 60 percent so far in 2025.
Exchange filings show Aggarwal sold about 2.6 crore shares through a bulk deal on Tuesday, December 16, resulting in a reduction in his shareholding. The sale was linked to the repayment of a personal loan of around Rs 260 crore, raised to fund his artificial intelligence venture, Krutrim AI. To secure the loan, Aggarwal had pledged a portion of his Ola Electric shares with lenders, including Axis Trustee and Aditya Birla.
Analysts said the sale likely helped address risks linked to pledged shares at a time when the stock continued to hit fresh lows. Pledged holdings are typically vulnerable to margin calls during steep price declines, which can lead to forced selling, though the precise trigger for the transaction was not disclosed.
Sunny Agrawal, head of fundamental equity research at SBICAPS, said the release of pledged shares removes a key overhang on the stock, particularly the risk of further sell-offs linked to margin calls. With that pressure now addressed, investor focus shifts back to the company’s underlying business performance, which is only getting weaker, he said.
Analysts said Ola Electric’s core electric scooter business continues to struggle, with volumes yet to scale meaningfully and competition intensifying. The company’s market share in electric scooters has fallen to around 18 percent from roughly 45 percent at the time of its listing, which analysts cited as a key concern.
Some analysts noted that Ola Electric has been developing additional business verticals, including battery cell manufacturing, which could serve both its own vehicles and other automotive segments. Whether these initiatives can offset weakness in the core scooter business will depend on product execution, customer response, and scalability, they said.
Rajesh Palviya of Axis Securities said the stock is trading at an all-time low and that any rebound, if it occurs, is likely to be driven by near-term news flow rather than a fundamental turnaround. The technical setup remains weak, and investors are likely to wait for confirmation through quarterly earnings before reassessing the stock, he said.
Ola Electric said the transaction was a one-time and limited monetisation by the founder at a personal level to repay a promoter-level loan of Rs 260 crore. Following the repayment, all previously pledged shares, representing about 3.93 percent of the company’s equity, will be released. The promoter group will continue to hold around 34 percent of the company, with no change in promoter control or long-term commitment, the company said.
Independent analyst Jayant Mundhra said pledged shares pose heightened risks during sharp stock price declines, as lenders may issue margin calls that lead to selling in the open market. He said that risk was present as Ola Electric’s shares continued to slide and has now been addressed following the transaction.
Click here to add News18 as your preferred news source on Google. December 17, 2025, 13:12 IST
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Business
Rupee rebounds! Currency recovers on likely RBI intervention after opening at 91.07 vs US dollar; biggest single-day gain in 7 months – The Times of India
Rupee stayed under pressure on Wednesday, opening at a record low of 91.07 against the US dollar, down 0.05% from its previous close, before clawing back part of its losses, likely supported by intervention from the Reserve Bank of India (RBI), Reuters reported.The central bank stepped in aggressively after the currency hit record lows for four straight sessions, triggering its strongest intraday recovery in about seven months. The rupee had been weighed down by sustained portfolio outflows and an ongoing stalemate in US–India trade talks.After opening near 91.07, the rupee rebounded sharply, rising to an intraday high of 89.75 on the interbank order matching system from levels close to 91 seen before the intervention.
Market participants noted that Wednesday’s intervention mirrored RBI actions in October and November, when it stepped in on multiple occasions to curb one-way moves in the currency.Earlier on Tuesday, the domestic currency breached the 91-per-dollar mark for the first time during intraday trade, touching an all-time low of 91.14 before recovering partially to close 15 paise weaker at 90.93. Traders said the decline came despite weakness in the US dollar and a sharp fall in global crude oil prices.Rupee has been under sustained stress in recent sessions. It slipped past the 90-per-dollar level on Monday and has hit fresh record lows for the third straight session, driven by concerns over a prolonged deadlock in India–US trade talks and persistent portfolio outflows. Over the past 10 trading sessions, the currency has fallen from around 90 to 91 against the dollar, losing nearly 1% in just the last five sessions. Traders said the period was marked by strong dollar demand and a disconnect between the rupee and other Asian currencies, alongside growing interest in speculative short positions.So far this year, the rupee is among the worst-performing global currencies, down about 6% against the greenback. A widening trade deficit, punitive 50% US tariffs and steady investment outflows have pushed the currency to record lows near the 91 level.
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From a modest garage to a IT powerhouse, his journey reshaped India’s tech dreams. But what truly sets him apart is how quietly his wealth flows back into society every single day
Shiv Nadar founded HCL in a garage in 1976, growing it into a global IT giant. (Photo Credit: Shiv Nadar Foundation)
Success Story: One name stands out whenever India’s IT success stories are told: Shiv Nadar. What began in a modest garage in 1976 went on to become Hindustan Computers Limited (HCL), one of India’s leading global IT companies.
Today, Shiv Nadar is not only a celebrated entrepreneur but also one of the country’s most generous philanthropists, donating nearly Rs 7.4 crore every day.
From A Small Garage: The Birth Of HCL
Shiv Nadar was born on July 14, 1945, in the Tiruchirappalli district of Tamil Nadu. After completing his engineering education, he joined the DCM Group. During his time there, discussions with colleagues about the future of computers and electronics in India sparked a bold idea, that is, to start something of their own.
In 1976, Shiv Nadar and a small group of engineers founded HCL from a garage in Delhi. Initially, the company focused on computer hardware and electronic products, with a clear aim: to bring computer technology to India and create employment opportunities for young professionals.
Challenges On The Road To Success
The early years were far from easy. HCL faced financial constraints, technical hurdles, and intense market competition. However, Shiv Nadar’s long-term vision and commitment to innovation kept the company moving forward. He firmly believed that technology should simplify lives and drive progress for everyone.
During the 1980s and 1990s, HCL diversified from hardware manufacturing into software development and IT services. The company steadily expanded beyond India, establishing operations across the US, Europe, and Asia.
Today, HCL Technologies operates in nearly 60 countries and employs more than 2,22,000 people. It is a major player in areas such as cloud computing, cyber security, digital transformation, and enterprise software solutions.
Passing The Baton To Roshni Nadar Malhotra
After leading HCL for over four decades, Shiv Nadar stepped down as chairman in 2020. He appointed his daughter, Roshni Nadar Malhotra, as the new chairman, making her the first woman to hold the position in the company’s history.
Shiv Nadar now serves as Chairman Emeritus and Strategic Advisor.
According to the Bloomberg Billionaires Index, Shiv Nadar’s net worth stands at $38.2 billion (approx. Rs 3.17 lakh crore), placing him among the world’s richest individuals at 54th position globally. As of now, HCL’s market capitalisation is Rs 4,49,369 crore.
Commitment To Social Service and Philanthropy
Shiv Nadar’s legacy extends far beyond business. Through the Shiv Nadar Foundation, he has made significant contributions to education by establishing schools and universities across India.
As per the ‘EdelGive-Hurun Philanthropy List 2025’, Shiv Nadar and his family topped the list of India’s biggest philanthropists for the fourth time in five years. In the past year alone, the family donated Rs 2,708 crore, averaging Rs 7.4 crore every day. In recognition of his contribution to the IT sector and his vision for empowering India’s youth, Shiv Nadar was awarded the Padma Bhushan in 2008. Today, HCL symbolises India’s technological strength on the global stage.
Shiv Nadar’s journey proves that extraordinary success can begin with the smallest of steps. From a single garage to a global IT empire, his story remains one of vision, perseverance, and purpose.
Click here to add News18 as your preferred news source on Google. December 17, 2025, 08:07 IST
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