Sandoz reorganises ahead of 'golden decade' for biosimilars

Sandoz is carving out a global unit dedicated to development, manufacturing and supply of biosimilar medicines as it prepares for an approaching wave of patent expiries.

The new unit will be led by Armin Metzger, who joins the company April 1 after serving in senior technical roles at Ferring Pharmaceuticals since 2016, most recently as Chief Technical Operations Officer, and earlier spending nearly two decades at Merck KGaA and its biopharmaceutical division Merck Serono.

$650B patent cliff

"We stand today at the start of an unprecedented 'golden decade' for patient access, with medicines worth more than $650 billion set to lose exclusivity over the next 10 years," said Sandoz CEO Richard Saynor in a release Tuesday.

According to the company, consolidating biosimilar development, manufacturing and supply under one executive is meant to speed up decision-making and accelerate vertical integration across the business.

Sandoz, which was spun off from Novartis in 2023, has built a strategy around both biosimilars and traditional generics. Generic medicines still dominate the company's portfolio, accounting for about 70% of net sales globally in 2025 and an even larger share by volume.

Two paths

However, the two segments increasingly require different approaches. "Despite their many synergies, the two parts of the business have different development, manufacturing and supply requirements, as well as increasingly divergent market dynamics," Saynor said. "This change will enable us to focus our efforts more sharply on accelerating biosimilar growth while further strengthening our generic operations."

Under the new structure, Claire D'Abreu-Hayling will become president of generics development while retaining her role as Chief Scientific Officer, and Glenn Gerecke, currently Chief Manufacturing & Supply Officer, will serve as president of generics manufacturing and supply. The reorganisation also adjusts reporting lines in Europe, with Germany's country head Thomas Weigold reporting into Christophe Delenta, president of the European regional segment.

FDA draft guidance

The changes come as regulators in the US signal their continued efforts to lower barriers to biosimilar development. Earlier this week, the FDA issued revised draft guidance recommending streamlining "unnecessary clinical pharmacokinetic (PK) testing when scientifically justified," a move it estimates could save biosimilar developers up to 50% of their PK study costs, or roughly $20 million.

"Using common sense, we are embracing more precise analytical testing approaches than have been used in the past," stated FDA Commissioner Marty Makary. The agency last year proposed making it easier and cheaper to develop biosimilars by doing away with requirements for certain human studies.

https://firstwordpharma.com/story/7131922