Sandoz has not minced words about the massive yet largely untapped opportunity biosimilar makers are presented with as dozens of branded medicines inch toward the patent cliff in the next decade.
Now, in an effort to fully capitalize on what the company recently referred to as a potential “‘golden decade’ of affordable medicines” after 2030, Sandoz is committing even further to its biosimilar business with plans to launch a dedicated unit that will operate separately from the company’s remaining small molecule generics division.
The new biosimilar unit, focused on development, manufacturing and supply of copycat biologic drugs, will be led by Armin Metzger, most recently chief technical operations officer at fellow Swiss drugmaker Ferring Pharmaceuticals.
Metzger, who has also held positions at Merck KGaA, will officially adopt the title of president, biosimilar development, manufacturing and supply, and join Sandoz’s executive committee April 1, according to a March 10 press release.
By splitting up the units, Sandoz said it hopes to enable “clear ownership, fast decision-making and stronger alignment” for its biosimilar operations. The move is expected to benefit its “lower-cost, higher-volume” small molecule generics, too, with Sandoz describing the success of that bread-and-butter unit as still “central to the long-term Sandoz strategy, as the only ‘pure-play’ biosimilars and generics company.”
The former Novartis unit noted in its release that generic medicines made up 70% of its global sales in 2025, with that proportion even higher by volume.
Still, biosimilars stand to gain tremendously in the coming years if their developers can capitalize on a wave of upcoming patent losses. Medicines worth more than $650 billion collectively are set to lose exclusivity over the next 10 years, Sandoz’s CEO, Richard Saynor, noted in a statement Tuesday.
“As the global leader in affordable medicines and the pioneer of biosimilars, Sandoz is determined to capture this opportunity and deliver strong, sustainable growth,” Saynor said.
Apart from Metzger’s appointment, several other Sandoz executives are shuffling around with the launch of the dedicated biosimilar unit. Claire D’Abreu-Hayling, currently the company’s chief scientific officer, is slated to also take on the title of president of generics development, and Glenn Gerecke, Ph.D., the company’s chief manufacturing and supply officer, will more specifically serve in that role for generics once the new biosimilar structure is in place.
Sandoz noted that the planned changes won’t affect its guidance for 2026 or its medium-term outlook.
Sandoz’s passionate endorsement of biosimilars comes as off-patent biologic meds have struggled to gain meaningful traction in the key U.S. market, disincentivizing widespread development and leading the industry to face what some have called a “biosimilar void.”
To put things into perspective, there were some 118 biologics expected to lose patent protection over the next nine years, but, as of February 2025, just a dozen of those more than 100 meds had biosimilars in development, according to a report from IQVIA last year.
At the time it issued its findings, IQVIA attributed the biosimilar development drought to factors like complex regulatory requirements, slow market adoption, high investment costs, tricky reimbursement dynamics and an increasingly shifting policy landscape.
As for the particular opportunity Sandoz is eyeing, the company said during its presentation at the J.P. Morgan Healthcare Conference earlier this year that it sees a biosimilar opportunity worth some $322 million in the next decade, noting that it plans to target a roughly 60% piece of that biosimilar pie.
Still, Keren Haruvi, Sandoz’s North American president, 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 taken strides to improve biosimilar availability in the U.S. and ease the burden on developers.
Earlier this week, the FDA released draft guidance that would seek to streamline pharmacokinetic testing for biosimilars—a key part of their regulatory comparison to reference biologics—when “scientifically justified.”
“Streamlining biosimilar development reflects our ongoing commitment to lowering drug costs for everyday Americans,” FDA Commissioner Marty Makary, M.D., said of the proposed guidance in a statement. “Using common sense, we are embracing more precise analytical testing approaches than have been used in the past.”