Sandoz didn’t mince words about the huge but largely untapped opportunity facing biosimilar makers, as dozens of branded drugs edge toward the patent cliff over the next decade.
Now, as part of its efforts to take full advantage of what the company recently referred to as a potential “golden decade” of affordable medicines beyond 2030, Sandoz is further focusing on its biosimilars business with plans to launch a specialized division that will operate separately from the rest of the company’s small molecule generics division.
The new biosimilars division will focus on the development, manufacturing and supply of mimicking biologics and will be led by Armin Metzger, who most recently served as chief technical operations officer at fellow Swiss pharmaceutical company Ferring Pharmaceuticals.
Metzger, who also held positions at Merck KGaA, will officially adopt the title of president of biosimilars development, manufacturing and supply, and will join Sandoz’s executive committee on April 1, according to a March 10 press release.
Sandoz said he hoped to separate the divisions to allow for “clearer ownership, faster decision-making and stronger collaboration” in the biosimilars business. The move is also expected to benefit the company’s “low-cost, high-volume” small molecule generic drugs, with Sandoz saying the success of this bread-and-butter division remains “central to Sandoz’s long-term strategy as the only ‘pure’ biosimilars and generics company.”
The former Novartis unit noted in a release that generic drugs accounted for 70% of global sales in 2025, and the proportion was even higher on a volume basis.
Still, biosimilars could reap significant gains in the coming years if developers can take advantage of the upcoming wave of patent losses. Sandoz CEO Richard Thaner said in a statement Tuesday that drugs worth more than $650 billion are expected to lose exclusivity over the next decade.
“As a global leader in affordable medicines and a pioneer in biosimilars, Sandoz is determined to seize this opportunity and deliver strong, sustainable growth,” said Mr. Sayner.
Separate from Metzger’s appointment, several other Sandoz executives are in the mix as the company prepares to launch a dedicated biosimilars unit. The company’s current chief scientific officer, Claire Dabreu-Hayling, will also assume the role of president of generic drug development, and the company’s chief manufacturing and supply officer, Dr. Glenn Gerecke, will take on a more specific role with respect to generic drugs once the new biosimilar structure is in place.
Sand noted that the planned changes do not affect the outlook for 2026 or the medium-term outlook.
Sandoz’s enthusiastic support for biosimilars comes as off-patent biologics have struggled to gain meaningful traction in the key U.S. market, discouraging widespread development and leaving the industry in what some have called a “biosimilar vacuum.”
To put things into perspective, a report from IQVIA last year found that while there were approximately 118 biologics expected to lose patent protection over the next nine years, as of February 2025, only 12 of the more than 100 drugs in development had biosimilars.
At the time of publishing its findings, IQVIA attributed the drought in biosimilar development to factors such as complex regulatory requirements, slow market adoption, high investment costs, difficult reimbursement mechanisms, and an increasingly changing policy landscape.
As for the specific opportunities Sandoz is eyeing, the company said in a presentation at the JPMorgan Healthcare Conference earlier this year that it sees about $322 million worth of biosimilar opportunities over the next 10 years, and plans to target about 60% of that biosimilar pie.
Still, Sandoz’s North American president, Kellen Halvey, told Fierce Pharma in an interview at the conference that “we want to do more” when it comes to biosimilars.
On the regulatory front, the FDA has also made strides to improve the availability of biosimilars in the United States and ease the burden on developers.
Earlier this week, the FDA released draft guidance aimed at streamlining pharmacokinetic testing of biosimilars, an important part of regulatory comparisons with reference biologics, when “scientifically justified.”
“Streamlining biosimilar development reflects our continued commitment to reducing drug costs for everyday Americans,” FDA Commissioner Marty McCulley, MD, said of the proposed guidance in a statement. “Based on common sense, we employ a more accurate analytical testing approach than has been used in the past. ”
