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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 said the FDA has an “outdated and burdensome approval process that has slowed down the entry of biosimilars.”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
Tesco and Sainsbury’s non-loyalty brand prices more expensive than Waitrose
Tesco and Sainsbury’s customers are paying more than Waitrose shoppers for some common branded groceries if they are not using a loyalty scheme, analysis by Which? has found.
The watchdog compared a list of 245 branded items including Heinz, Nescafe and Mr Kipling in February, finding that it was, on average, most expensive for customers at Sainsbury’s and Tesco who were not using the Nectar or Clubcard loyalty schemes.
Which? acknowledged that most shoppers are part of a membership scheme, but said some may be unwilling to sign up to loyalty cards for reasons such as data privacy, while others have no choice because of eligibility criteria.
Tesco customers who are under 18 can not sign up to a Clubcard, although the supermarket has announced it will review this before the end of the year.
The Which? list of items was most expensive at Sainsbury’s for non-Nectar members at £942.66 – 14% more than the cheapest retailer in the study Asda, which cost £823.58.
Tesco followed behind Sainsbury’s, with its non-Clubcard price totalling 11% more than Asda at £916.56.
Which? said it did not include discounters Aldi and Lidl in the study because they did not stock a sufficiently large range of branded goods.
Both Tesco and Sainsbury’s – the UK’s two largest grocers – were more expensive for non-members of their loyalty schemes than Waitrose, which cost £899.05.
Waitrose was 9% more expensive than Asda and emerged as a “more competitive option”, Which? said.
Which? found several products that were cheaper at Waitrose, including Amoy Straight To Wok Noodles, which were on average £1.25 at both Waitrose and Morrisons but most expensive at Sainsbury’s and Tesco without a loyalty card at an average of £2.15 – a 72% difference.
Sea salt and vinegar Ryvita Thins were also cheapest on average at Waitrose at £1.25, but shoppers buying this product at Morrisons, Tesco, and Sainsbury’s without a loyalty card would all have paid an average of £2.30, making them 84% more expensive.
For customers with a Clubcard, Which? found that the same list of groceries at Tesco fell to £837.43 on average – just 2% more expensive than Asda.
Which? found various instances of branded products where the Tesco Clubcard price was the cheapest on average.
Carex Hand Wash was 95p at Tesco with a Clubcard but £1.70 at Waitrose where it was the most expensive.
Another example showed Kellogg’s Crunchy Nut cornflakes was £1.55 on average in February, while the highest average price among the supermarkets was at Waitrose where it cost £2.50.
Which? said the figures showed the “dramatic price gulf” created by loyalty pricing.
In one example at Tesco, Which? found a 200ml bottle of L’Oreal Paris Elvive Bond Repair Shampoo was double the price on average for shoppers without a Clubcard – at £13 compared to £6.50.
The higher price was also found at both Morrisons and Sainsbury’s.
Which? found that a 200g jar of Kenco Smooth coffee cost shoppers at Tesco and Sainsbury’s without a loyalty card £8.35 – the highest price on the market.
In contrast, the same jar was £7 at Waitrose and £6.32 at Asda, on average.
Similarly, Waitrose had the cheapest average price for Nescafe Gold Blend at £6.25, while non-members at Sainsbury’s were asked to pay £8.35.
Meanwhile, Which? found customers who used a Nectar card at Sainsbury’s could expect to pay only 3% more than Asda at £848.56 for the entire list of items.
Morrisons averaged 4% more expensive than Asda when using a More card and 5% more expensive without one.
Ocado was also 5% more expensive than Asda.
Which? retail editor Reena Sewraz said: “Our analysis reveals a shocking truth and shows the impact loyalty schemes have had on grocery pricing.
“Branded favourites can actually be cheaper at Waitrose than at the UK’s biggest supermarkets for shoppers who don’t use a loyalty card – something that would have seemed unthinkable until a few years ago.
“If you’ve got your heart set on specific brands, your best bet is to shop around, keep a close eye on the unit price, and stock up whenever you see a good deal – otherwise, you’re likely to end up paying way over the odds.
“While loyalty cards definitely offer some savings, if you don’t use one you’re better off heading to Asda, where the pricing is usually cheaper on a range of branded goods.”
A Sainsbury’s spokesman said: “We have invested over £1 billion in recent years to help keep prices low and we know more customers are choosing to do their shop at Sainsbury’s.
“We are committed to helping customers access great quality at lower prices and remain focused on offering outstanding value across thousands of products through our Aldi price match scheme, Nectar prices, Your Nectar Prices and our own-brand value lines.”
A spokesman for Tesco said: “It’s no secret that Tesco Clubcard unlocks exceptional savings for the 24 million UK households who have one.
“More than 80% of our sales are made with a Clubcard – but it’s just one of the ways our customers get great value.
“Though everyday low prices we keep prices consistently low on thousands of branded products, and our Aldi price match ensures shoppers can be confident they’re getting competitive prices.”
Business
MLB faces a historic shift as potential lockout, media rights and other league changes loom
Thursday’s Opening Day may be the calm before the storm for Major League Baseball.
The league’s collective bargaining agreement with its players expires at the end of this season. Owners, with the commissioner’s backing, are almost sure to push for a salary cap (which would likely come with a salary floor to get players to the negotiating table).
MLB owners have never been able to get a cap passed by the players union. It’s unclear if the end of the 2026 season will lead to a different result, but MLB Players Association Interim Executive Director Bruce Meyer told ESPN last month he expects a lockout is “all but guaranteed.”
In addition to the CBA’s expiration, there are major shifts underway for baseball media rights. One-third of the league’s teams didn’t have local TV deals in place for this season until this week.
Nine MLB teams – the Washington Nationals, Seattle Mariners, Milwaukee Brewers, St. Louis Cardinals, Miami Marlins, Tampa Bay Rays, Cincinnati Reds, Kansas City Royals, and Detroit Tigers – announced Wednesday their brand new MLB-operated team channels will be carried by DirecTV.
Most of those teams had previously been part of Main Street Sports (previously Diamond Sports Group), which operates FanDuel Sports Networks (previously Bally Sports). That entity has been teetering with liquidation, and the teams terminated their contracts with the company due to missed payments earlier this year.
A 10th team, the Atlanta Braves, is launching a new network called BravesVision. The Braves and Charter’s Spectrum announced a multiyear distribution agreement earlier this week.
MLB ideally wants the rights to all 30 teams in its control by the end of the 2028 season so that it can sell the in-market local games as a national package to a streamer. That would become the modern replacement to regional sports networks, and it would likely be a new, coveted package for streaming services such as ESPN and Amazon Prime Video.
Also at the end of the 2028 season, MLB’s national media rights for all of its packages will expire, allowing the league to redistribute games to its partners and potentially select new ones.
NBC, ESPN, Fox and a combined CBS/Turner have dominated national rights for the past few decades.
“The key in media negotiations now is having all of your rights available,” MLB Commissioner Rob Manfred told me last year. “If you have all of your content – all of your playoffs, all of your regular season – available, there will be buyers, and I’m confident there will be buyers at a higher price for us.”
Manfred has even floated the idea of expanding to 32 teams and realigning the league geographically, upending or even eliminating the American and National leagues that have existed for more than 100 years.
Soaring TV ratings
It’s, of course, unclear how much of this hypothetical change will actually come to fruition.
But the potential for transformation at MLB is greater than at any of the other Big 4 professional leagues in the U.S.
And yet, baseball isn’t struggling — on the contrary. The implementation of the pitch clock in 2023 has led to shorter games, rising attendance and higher TV ratings.
Rob Manfred, Commissioner of the MLB, attends the annual Allen and Co. Sun Valley Media and Technology Conference at the Sun Valley Resort in Sun Valley, Idaho, U.S., on July 9, 2025.
David A. Grogan | CNBC
More than 50 million people in the U.S., Canada and Japan watched Game Seven of the World Series last year – the most-watched baseball game in 34 years. MLB recently wrapped up the World Baseball Classic – a global preseason tournament – which captured nearly 11 million viewers on Fox and Fox Deportes for its final game.
MLB team valuations rose 13% from last year. The average MLB team is now worth $2.95 billion, according to CNBC Sport data.
Still, the profitability of the league is in far worse shape than it is for the NFL, NBA and NHL, according to CNBC’s calculations. In 2025, MLB’s 30 teams had an EBITDA — earnings before interest, taxes, depreciation and amortization — margin of under 2%. Team average revenue was $426 million with average EBITDA of $7 million, including non-MLB ballpark events. In contrast, the comparable margin for the NFL was 20%; the NBA, 21% and the NHL, 22%, according to CNBC’s most recent valuations.
The new CBA at the end of this season could be the first significant step toward a very different MLB. But, similar to the WNBA, which announced its new CBA earlier this week, MLB must ensure negotiations to get a new labor agreement don’t jeopardize a wave of positive momentum.
Business
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