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June 2026 saw strong biosimilar momentum with key approvals and regulatory milestones, including Ranluspec (US FDA), Tofidence sBLA (US FDA), Liyoubao (NMPA), Zandoriah (EC), and multiple ANVISA approvals, alongside submissions for CT-P55 (Health Canada) and ADL-018 (Health Canada), expanding treatment options across immunology, ophthalmology, oncology, osteoporosis, and reproductive medicine.
Strategic collaborations between Chime Biologics–Daewoong, Polpharma Biologics–PSI CRO, Xbrane–JOINN, Samsung Bioepis–Organon, and Orion Pharma–Shilpa Biologicals advanced global biosimilar development and commercialization.
Commercial and clinical progress accelerated with the EU launch of Ahzantive, Canadian launches of Bildyos and Tuzemty, FDA acceptance of multiple BLA submissions, first patient dosing of HLX17, and positive late-stage data for SB27 and SPD8, highlighting continued global biosimilar market expansion.
Celltrion Seeks…
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The ANVISA has approved Uztok, a biosimilar version of Stelara (ustekinumab)
Ustekinumab is a human interleukin-12 and -23 antagonist
Uztok is indicated for Plaque psoriasis, Psoriatic arthritis, Crohn's disease, and Ulcerative colitis
Ref: Gov.br | Image: SteinCares | Press Release
Related News: Celltrion Plans to File for Approval of Herzuma SC (Biosimilar, Herceptin) in Europe and Korea
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Celltrion has applied to Health Canada for marketing authorization for CT-P55, a biosimilar of Cosentyx (secukinumab), for all indications held by the reference product, including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and juvenile idiopathic arthritis
The application was based on a clinical study in 172 healthy subjects, in which CT-P55 demonstrated pharmacokinetic equivalence to the reference product and comparable…
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Polpharma Biologics has entered into a licensing agreement with Tuteur to commercialize a biosimilar candidate for autoimmune diseases across Latin America, excl. Brazil
As per the deal, Tuteur will handle commercialization, marketing, & distribution in the licensed territories, while Polpharma will be responsible for the development & manufacturing of the biosimilar candidate
The biosimilar…
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Antengene has granted UCB a global exclusive license to develop, manufacture, & commercialize ATG-201 for B-cell–related autoimmune diseases, plus access to Antengene’s associated manufacturing tech supporting the therapy
As per the deal, Antengene will receive $80M in upfront & near-term milestones & ~$1.1B in development & commercial milestones, as well as net sales-based tiered…
Earendil Labs and Sanofi Forge ~$2.56B Deal to Advance Bispecific Antibodies for Autoimmune Diseases
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Earendil Labs has entered into a strategic collaboration with Sanofi to advance bispecific candidates for autoimmune & inflammatory diseases using Earendil's discovery platform
Under the deal, Earendil Labs will identify & optimize bispecific antibody candidates for autoimmune & inflammatory disease targets, while Sanofi will handle the development & worldwide commercialization of the products
As…
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Dren Bio has partnered with Sanofi to discover & develop next-generation B-cell depleting therapy for the treatment of various autoimmune diseases
As per the deal, Dren Bio will receive $100M upfront & ~$1.7B in milestones, with both parties jointly leading discovery & preclinical work using Dren Bio’s platform, after which Sanofi will handle…
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Boehringer Ingelheim and CDR-Life signed a global licensing deal to develop CDR111, a trispecific M-gager T-cell engager targeting and depleting B cells to help reset the immune system in autoimmune diseases
As per the deal, CDR-Life could receive up to CHF 456M (~$570M), including CHF 38M (~$ 48M) upfront and near-term payments, plus tiered…
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Kaigene has granted Celltrion exclusive global rights to develop & commercialize KG006 (excl. Greater China & Japan) & KG002
As per the deal, Kaigene will receive $8M upfront, & ~$736M in milestone payments, incl. $11M in near-term milestones through the initiation of P-I trials, along with net sales-based tiered royalties
KG006 is an FcRn…
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BI has licensed a pre-clinical small molecule program from Kyowa Kirin to develop it as a potential treatment for autoimmune diseases
As per the deal, BI will receive exclusive rights to develop the small molecule program globally, expanding BI’s inflammatory pipeline
In contrast, Kyowa Kirin will receive up to €640M (~$744.4M), incl. an upfront payment, development,…

