As part of a long-term growth strategy, Swiss company Sandoz is looking to capitalize on the loss of exclusivity in the global biosimilar market for biologic and small molecule medicines by building a flexible and cost-competitive development, manufacturing, and supply network designed to help usher in a “golden age” for its biosimilars.

At Tuesday’s Capital Markets Day event, Sandoz unveiled an ambitious plan to more than double net sales from 2025 to 2035 while setting its sights on having more than 100 biosimilars in its portfolio by 2040 — up from a total of 13 currently. 

Under Sandoz’s Bio100 initiative, the company will invest approximately $300 million in a new drug substance facility in Ljubljana, Slovenia to expand its biosimilar manufacturing capacity. The Ljubljana plant, expected to be operational from 2029 and located next to a recently opened biosimilar development center, will feature disposable fed-batch capacity of 8kl — four 2kl reactors — for clinical batches and commercial supply for low-to-medium volume drug substance products.

Last year, Sandoz broke ground on a $440 million biosimilar manufacturing site in Slovenia. The facility in Brnik, due to open in 2028, will support preparation, filling, assembly, and packaging of sterile injectable products. The new site will complement Sandoz’s existing operations in Slovenia which include a biosimilar drug substance production center in Lendava with 120kl of installed large-scale, stainless steel fed-batch capacity.

Future end-to-end European hub

Armin Metzger, president of biosimilar development, manufacturing and supply at Sandoz, told analysts on Tuesday the company will “translate the Bio100 ambition into reality” with vertical integration of an in-house European network from drug substance production to fill-finish capabilities.

“As our in-house network comes online, we are going to be in full control of the end-to-end value chain from development to drug substance manufacturing to fill and finish,” Metzger said. “Our setup is flexible with significant capacity and built-in opportunities for further expansion in the network spanning Slovenia, France, and Germany.”

Bringing development and manufacturing in house is one of the most important aspects of Sandoz’s Bio100 strategy, according to Metzger, who added that all the company’s facilities in Europe will use “state-of-the-art” digitally integrated systems with the highest quality standards.

“Today, as is the case for many other industry players, a large part of biosimilar development and manufacturing is externally sourced,” Metzger said. “What we are doing at Sandoz is fundamentally changing that with a clear ambition to move between 50% and 70% in-house development and around 60% [in-house] in manufacturing.”  

Sandoz’s European biosimilar hub is meant to provide the internal capabilities and capacities to help drive future growth, including fit-for-purpose drug substance production combining three technologies — disposable fed-batch, stainless steel fed-batch, and continuous manufacturing.

Last year, Sandoz announced the acquisition of Evotec’s biologics facility in Toulouse, France. The deal, for a total consideration valued at more than $650 million in potential payments plus royalties, expands Sandoz’s in-house biosimilar development and continuous manufacturing capabilities with automation designed to enable end-to-end, at-scale production. 

However, Metzger on Tuesday said Sandoz will continue to pursue strategic partnering with external developers and contract manufacturers to ensure the optimization of resources given rapidly expanding demand.

“We can’t and we won’t do everything ourselves — we will continue to work with third parties where appropriate,” Metzger commented, noting that Sandoz last month announced a new collaboration with China’s Shanghai Henlius Biotech to commercialize up to 10 biosimilars.

Under the terms of the agreement worth up to $322 million, Sandoz will have global commercialization rights for agreed biosimilar assets outside China while Henlius will be responsible for development and manufacturing.

“In the near term, external partners will continue to help us bridge capacity and share investment but over time we will shift to our owning the critical capabilities which will significantly improve returns,” Metzger said.

As part of its Bio100 strategy, Sandoz’s intends to find a “balance” between in-house and external development and manufacturing by 2030 and accelerate growth from in-house capabilities by 2035, building end-to-end biosimilars from cell line to commercialization.