Despite the barriers to biosimilar development, several pharmaceutical organizations are fully committed to their biosimilar future. Over the course of the next several months, BR&R will highlight some of these intriguing pipeline portfolios. We’re kicking it off in this post with Sandoz’s biosimilar pipeline; the company just announced a much broader pipeline initiative.
Whereas some manufacturers are reticent about giving too much information about their pipeline—possibly because of concerns of competitive intelligence or deals in the works—Sandoz has a list of 26 active biosimilar programs publicly disclosed on its website but says there are up to 39 candidates in the Sandoz biosimilar pipeline today. For context, only some of these biosimilar candidates are based on their own research and development. Whereas in the earlier days of the US biosimilar market, Sandoz was the sole force behind the commercialization of the first biosimilar approved in the US, Zarxio, and the first denosumab approved in the US, Jubbonti/Wyost, Ziextenzo (pegfilgrastim), and Enzeevu, an aflibercept biosimilar. It has focused more recently on being a marketing partner to other biosimilar manufacturers. This includes partnerships with Polpharm (e.g., Tyruko), Samsung Bioepis (e.g., Pyzchiva), Bio-Thera Solutions (e.g., Avzivi), Henlius (e.g., Erbitux), Formycon AG (e.g., Cimerli), and Eirgenix (e.g., Perjeta).
That is not to say it is not involved in biosimilar R&D today; on September 8, Sandoz announced its new “Bio100” initiative. With Bio100, Sandoz intends “to have more than 100 biosimilars in the portfolio by 2040, from a current total of 13.” In its press release, the company says it will nearly “double current [loss of exclusivity] coverage to around 80% from 2035 onwards.” In simpler terms, this means that the company seeks to have pipeline products for nearly 80% of biologics that have lost exclusivity by 2035. That could also mean that it will be looking more broadly at the products that are stuck in the biosimilar void today.
Higher Revenue Targets Today, Biosimilar Void Targets Tomorrow?
Look no further than the sales estimate for the reference products being targeted at the moment: the range is from $2 billion for several products to $31 billion for Keytruda. Of course, these net sales figures may be affected by both most favored nations agreements and future Medicare Maximum Fair Price (MFP) negotiations. The most powerful inducement to biosimilar development will always be potential profits; although this is a fact of life, of the 26 candidates in the Sandoz biosimilar pipeline, none of which would necessarily be considered part of the biosimilar void. One of the issues with the biosimilar void is that although patents on these biologics may have expired, net sales revenues are generally below $1 billion.
That is not true of the planned pipeline for its Bio100 initiative. Sandoz identified a multitude of patent expiration opportunities that coincide with lower-revenue products. With streamlining of the biosimilar development process, the company hopes that the associated reduced development costs will produce biosimilar candidates in this lower range of revenues.
Presently, Sandoz has some rare disease targets in its sights. The 2026 Sandoz biosimilar pipeline lists lanadelmumab (Takhzyro), efgartigimod alfa (Vyvgart), and ravulizumab (Ultomiris) in early development (reference product net sales, $2 billion, $8 billion, and $12 billion, respectively).
Furthermore, Sandoz is seeking to fortify its multiple sclerosis portfolio with the addition of a biosimilar ocrelizumab (Ocrevus), which is prescribed far more often than either its biosimilar Tyruko or the reference product Tysabri.
The next generation of immunology products are well represented on Sandoz’s pipeline, including early-stage research on guselkumab (Tremfya), vedolizumab (Entyvio), risankizumab (Skyrizi), and dupilumab (Dupixent).
Evolocumab (Repatha) is Amgen’s first-in-class PCSK9 inhibitor, and Henlius has a product in preclinical development. Should it ultimately be approved by the FDA, Sandoz will have commercialization rights in the US.
Adding to its ophthalmology biosimilar aspirations is an early-stage candidate for faricimab (Vabysmo), in addition to the forementioned aflibercept and marketed Cimerli products.
However, the company’s greatest current focus is on the oncology products Opdivo, Keytruda, Erbitux, Yervoy, Darzalex, Padcev, and Tecentriq. This is in addition to advanced formulations of trastuzumab (antibody–drug conjugate) and Opdivo (SC version).
Additional Biosimilar Products on the Radar
Luspatercept is an injectable erythroid maturation agent used to treat severe anemia associated with beta thalassemia and myelodysplastic syndromes.
Tezepelumab is a biologic used to treat severe asthma and chronic rhinosinusitis.
Burosumab is an injectable that is approved for the treatment of X-linked hypophosphatemia (XLH) and fibroblast growth factor 23–related hypophosphatemia in tumor-induced osteomalacia. This agent would complement its existing denosumab osteoporosis biosimilar.
Sotatercept is an activin-signaling inhibitor for the treatment of pulmonary arterial hypertension.
Anifrolumab is a biologic used as an add-on to standard therapy for patients with moderate-to-severe systemic lupus erythematosus. Also, Sandoz has a biosimilar candidate that it hopes will compete with Benylsta, the popular agent used to treat SLE (as a marketing partner to Henlius).
In-House Development vs. Partnerships vs. Both
The Bio100 announcement also emphasized Sandoz’s intent to focus on in-house development of biosimilars while also using partnerships to grow out the pipeline. Whereas currently, Sandoz has averaged about 2 biosimilars entering in-house development each year, it hopes to increase this number to 7 by 2035, and as many as 10 per year in 2040. Partnerships, with Sandoz as co-developers and/or marketers for other manufacturers, will be needed to fill out the broader expectations of Bio100 biosimilar candidates by 2040.
This article was written by our Director of Content, Stanton Mehr. Stan has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry’s original, comprehensive and updated database of biosimilar filings with the FDA.
