Skip to content Skip to footer

Key Biosimilars Events of June 2026 

Shots:  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…

Read more

SteinCares Receives ANVISA Approval for Uztok (Biosimilar, Stelara) 

Shots:  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   PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with…

Read more

Celltrion

Celltrion Seeks Canadian Approval for CT-P55 (Biosimilar, Cosentyx)  

Shots:  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…

Read more

Polpharma Partners with Tuteur to Commercialize a Biosimilar Candidate Across LATAM for Autoimmune Diseases

Shots: 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…

Read more

Antengene and UCB Strike ~$1.18B Deal to Advance ATG-201 for B-Cell–Related Autoimmune Diseases

Shots: 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…

Read more

Earendil Labs and Sanofi Forge ~$2.56B Deal to Advance Bispecific Antibodies for Autoimmune Diseases

Shots: 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…

Read more

Boehringer Ingelheim Licenses an Autoimmune Disease Therapy from Kyowa Kirin for ~$744.4M

Shots: 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,…

Read more