Spying a “golden decade” beyond the branded drug industry’s looming patent cliff, Sandoz is making big bets on its biosimilar capabilities in the coming years.
Under the company’s so-called Bio100 plan, Sandoz is setting the ambitious goal to establish a portfolio of more than 100 biosimilars by 2040, up substantially from the 13 it currently markets. Meanwhile, the company also aims to expand the overall biosimilar loss of exclusivity (LOE)-value it holds from some 50% today to around 80% from 2035 onwards.
Part and parcel to that, Sandoz hopes to double its net sales from 2025 through the middle of the next decade, according to a Sept. 8 release outlining the strategy. For all of last year, the Swiss drugmaker reported 5% net sales growth at constant currencies to $11.1 billion.
The company’s apparent urgency comes as brand-name drugmakers face a period of heavy patent losses toward the back half of the 2020s and early into the next decade.
In a presentation shared (PDF) as part of Sandoz’s announcement, the company noted that the combined off-patent market opportunities for biosimilars and generics equates to around $260 billion from this year into 2030, before new LOE opportunities prompt a swell to a projected $350 billion from 2031 through 2035 and $370 billion in the back half of the next ten years.
Further, the company noted an “unprecedented” number of LOEs slated to occur through around 2032, pointing to more than 60 biologics patent loss opportunities that exist within that “void.”
The biosimilar “void,” which multiple manufacturers have alluded to recently, refers to the incoming tranche of biologics losing exclusivity that don’t have biosimilars in development.
In the nearer term, Sandoz stressed that it maintains an “unchanged commitment” to its current outlook for 2028, under which the Novartis spinout has said it’s aiming for mid-single-digit growth. At the same time, however, the company laid out a new midterm outlook for 2025 through 2030, during which it’s now targeting mid-to-high single-digit compound annual net sales growth at constant exchange rates.
In terms of the work the company has in store, Sandoz will strive to target some $300 billion in originator LOE sales from 2026 through 2040, per the presentation. Sandoz also noted that under the Bio100 strategy, it will specifically home in on oncology and immunology assets, plus monoclonal antibodies and in-house development.
“The scale of our ambitions is matched by the strength of our plan,” Richard Saynor, Sandoz’s CEO, said in a statement Tuesday, pointing to the company’s “leading biosimilar pipeline, a scalable, flexible and cost-competitive biosimilar development, manufacturing and supply network, best-in-class commercial engines, a culture to attract and retain the best talent and disciplined focus on value creation.”
Helping pad Sandoz’s chances for success is the company’s extensive supply and manufacturing footprint. In particular, the company argued that it’s already “ahead of the curve” thanks to some $1 billion invested to build out what it describes as a leading biosimilar hub in Europe.
That gameplan revolves around sites in France, the U.K., Germany and Slovenia, where Sandoz also unveiled on Tuesday a $300 million investment on Tuesday to build a new drug substance facility in Ljubljana.
The project is expected to add 8,000 liters of biologics capacity to support Sandoz’s biosimilar supply network, with plans for the facility to come online in 2029. The facility will be co-located with Sandoz’s newly debuted biosimilar development center.
Framing the role of the new plant in Tuesday’s presentation, Sandoz noted that the site will expand capacity for clinical batches and commercial supply for “low-to-medium volume drug substance products.” The facility will leverage disposable fed-batch technology.
Despite expectations that biosimilars might fill an equally ubiquitous niche as small molecule generics, the reality of uptake has been a bit patchier in the U.S., though signals have been trending in positive directions in more recent years.
Meanwhile, multiple biosimilar players—from big names like Sandoz and Samsung Bioepis to upstart manufacturers—have flagged the opportunity biologic copycat developers could seize on as the branded industry’s patent cliff approaches.