Latest Biosimilar Deals Signal Growth Across Immunology, Oncology Markets

During the first quarter of 2025, pharmaceutical companies have taken charge to strengthen their biosimilar portfolios, announcing new deals and partnerships that are sure to provide patients across the immunology and oncology fields greater access to life-changing biologics.

At the top of April, Organon announced the acquisition of Tofidence (tocilizumab-bavi), a biosimilar approved by the FDA in October 2023 for the treatment of rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.^1,2

Tofidence’s American commercialization was run by Biogen, and under the terms of the new agreement, Organon will receive the regulatory and commercial rights to the biosimilar in the US.¹ However, Bio-Thera Solutions, the developer of Tofidence, will maintain manufacturing rights for the US market.

Organon will make an upfront payment to Biogen and assume responsibility for tiered royalty payments based on net sales, as well as tiered annual net sales milestone payments originally owed by Biogen to Bio-Thera Solutions.

Similarly, Accord Biopharma announced the completed acquisition of Udenyca from Coherus BioSciences.³ Udenyca (pegfilgrastim-cbqv) is an intravenous competitor to Neulasta (pegfilgrastim) for use in patients with cancer at risk of developing febrile neutropenia as a result of undergoing chemotherapy.

Udenyca gives patients options with 3 different ways to take it — an autoinjector, an on-body injector, or a prefilled syringe — so they can get treated at home, on the go, or right at their doctor’s office. Since it hit the market, Udenyca has reached more than 300,000 patients, with over 1.4 million units sold.

Additionally, people from Coherus’ sales, marketing, finance, supply chain, and manufacturing teams will be coming on board at Accord to help keep things running smoothly and support the continued success of the biosimilar.

A separate agreement between Accord and Bio-Thera pertaining to a golimumab biosimilar (BAT2506) was signed in February 2025.⁴ The biosimilar referencing Simponi (golimumab) is being developed to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. The originator currently has no biosimilars approved by the FDA and accumulated $3.2 billion in sales in 2023. As part of the deal, Bio-Thera will continue to handle the development, production, and supply of BAT2506, while Accord will hold exclusive commercialization rights in the United States.

Lastly, Lumicera Health Services has entered into a purchase agreement with Anda for a lower-cost biosimilar to Stelara (ustekinumab), one of the market’s most expensive prescription drugs.⁵ The deal allows Lumicera to acquire the unbranded biosimilar ustekinumab-aekn at a discounted net cost, which is projected to generate $120 million in annual savings for clients. These savings will be realized immediately through Lumicera’s acquisition cost-plus model, bypassing traditional rebate structures.

According to Lumicera, plan sponsors could save between $112,000 and $336,000 per patient annually compared with the cost of the reference product. As a result of the deal, Navitus Health Solutions, Lumicera’s parent company, will remove Stelara from its formulary starting July 1, 2025.

As a specialty pharmacy focused on cost transparency and affordability, Lumicera is one of the few operating under a true cost-plus model. The company is committed to reducing drug costs while ensuring patient access to critical treatments like those for Crohn disease, ulcerative colitis, and plaque psoriasis. Dispensing of ustekinumab-aekn is scheduled to begin on July 1, 2025.

References

1. Organon acquires Tofidence^™ (tocilizumab-bavi), a commercialized biosimilar to Actemra® (tocilizumab) injection, for intravenous infusion in the U.S. Press release. Organon; April 1, 2025. Accessed April 11, 2025. https://www.organon.com/news/organon-acquires-tofidence-tocilizumab-bavi-a-commercialized-biosimilar-to-actemra-tocilizumab-injection-for-intravenous-infusion-in-the-u-s/

2. Jeremias S. FDA approves first tocilizumab biosimilar. The Center for Biosimilars^®. October 5, 0223. Accessed April 14, 2025. https://www.centerforbiosimilars.com/view/fda-approves-first-tocilizumab-biosimilar

3. Accord BioPharma, Inc. announces completion of Udenyca^® (pegfilgrastim-cbqv) franchise acquisition from Coherus BioSciences, Inc., expanding U.S. biosimilar portfolio. Press release. Accord BioPharma; April 14, 2025. Accessed April 14, 2025. https://www.prnewswire.com/news-releases/accord-biopharma-inc-announces-completion-of-udenyca-pegfilgrastim-cbqv-franchise-acquisition-from-coherus-biosciences-inc-expanding-us-biosimilar-portfolio-302427584.html

4. Accord BioPharma strengthens pipeline through exclusive U.S. licensing agreement with Bio-Thera for BAT2506, a proposed golimumab biosimilar. Press release. Accord BioPharma; February 10, 2025. Accessed April 14, 2025. https://www.prnewswire.com/news-releases/accord-biopharma-strengthens-pipeline-through-exclusive-us-licensing-agreement-with-bio-thera-for-bat2506-a-proposed-golimumab-biosimilar-302372347.html

5. Lumicera secures purchase agreement for Stelara® Biosimilar, delivering major cost savings. Press release. Lumicera Health Services; March 13, 2025. Accessed April 14, 2025. https://www.businesswire.com/news/home/20250313878318/en/Lumicera-Secures-Purchase-Agreement-for-Stelara-Biosimilar-Delivering-Major-Cost-Savings