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NEWS

Henlius Reports First Patient Dosing in P-I Trial of HLX05-N (Biosimilar, Erbitux) in China 

Shots:  Henlius has dosed the first patient in China in the P-I HLX05-N (HLX05-N-mCRC102), a biosimilar version of Erbitux (cetuximab), for the treatment of metastatic colorectal cancer (mCRC)  The study will compare HLX05-N vs. US & EU sourced Erbitux in mCRC, evaluating PK similarity, efficacy, safety, and immunogenicity in combination with mFOLFOX6 CT  HLX05-N is Henlius' cetuximab biosimilar candidate, developed under global biosimilar guidelines, with analytical and non-clinical studies demonstrating high…
July 8, 2026

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INSIGHTS+

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…
July 7, 2026

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NEWS

Orion Pharma Expands Partnership with Shilpa Medicare for Nivolumab Biosimilar in the EU 

Shots:  Orion Pharma has entered into an agreement with Shilpa Biologicals to co-develop and supply IV nivolumab biosimilar across Europe  As per the deal, Orion will gain exclusive rights to register, market, distribute & sell the nivolumab biosimilar across the EU, while Shilpa Biologicals will lead product development, exclusively manufacture & supply the product, and receive development &…
July 6, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in May 2026    

Shots:  The European Medicines Agency (EMA) advanced multiple marketing authorizations and positive opinions in May 2026 across pulmonology, oncology, rare diseases, immunology, aesthetics, and endocrinology, involving companies including Boehringer Ingelheim, Novartis, AstraZeneca, AbbVie, Pharming, and Amgen.  CHMP positive opinions included Jascayd for idiopathic pulmonary fibrosis and progressive pulmonary fibrosis, Vijoice for PIK3CA-related overgrowth spectrum (PROS) disorders, Camizestrant (Etcamah) for ESR1-mutated advanced breast cancer,…
June 23, 2026

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NEWS

CSPC Pharmaceutical Reports the NMPA Approval of Secukinumab Injection (Biosimilar, Cosentyx) 

Shots:  The Chinese NMPA has accepted the marketing application for its secukinumab injection, a biosimilar version of Cosentyx, submitted as a Class 3.3 therapeutic biologic  The marketing authorization application is supported by a P-I PK similarity study in healthy volunteers and a P-III equivalence study in psoriasis pts, demonstrating that the product is highly similar to Cosentyx in efficacy, safety, PK, and immunogenicity. Detailed results will be…
June 18, 2026

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NEWS

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…
June 15, 2026

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Celltrion
NEWS

Celltrion Receives ANVISA Approval for Eydenzelt (Biosimilar, Eylea) 

Shots:  The ANVISA has approved Eydenzelt, a biosimilar version of Eylea (aflibercept)  Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor  Eydenzelt is indicated for adults with wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (CRVO/BRVO), diabetic macular edema (DME), and myopic choroidal neovascularization (CNV)  Ref: Gov.br |   Image: Celltrion   | Press Release Related News: Celltrion Plans to File for Approval of Herzuma SC (Biosimilar, Herceptin) in Europe and Korea  …
June 15, 2026

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Bayer
NEWS

Bayer Reports the US FDA Approval of Ambelvist to Enhance MRI Detection of Lesions 

Shots:  The US FDA has approved Ambelvist (gadoquatrane) for contrast-enhanced MRI to detect lesions with abnormal vascularity in the CNS and other body regions in adults and pediatric patients, including term neonates  Approval was supported by the global P-III (QUANTI) studies, which demonstrated that Ambelvist improved lesion visualization at a lower gadolinium dose (0.04 mmol Gd/kg) while providing diagnostic performance…
June 12, 2026

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Abbott
NEWS

Abbott Receives ANVISA’s Approval for Two Denosumab Biosimilars (Biosimilars, Prolia and Xgeva) 

Shots:  The ANVISA has approved two denosumab biosimilars (60 mg and 120 mg), a biosimilar version of Prolia and Xgeva in Brazil, expanding access to treatments for osteoporosis and cancer-related bone complications  The P-III SIMBA study confirms that Abbott's MB09 denosumab biosimilar demonstrates efficacy and safety comparable to the reference biologic, providing equivalent protection against bone loss in postmenopausal women  In 2023, mAbxience and Abbott partnered to develop, manufacture, and supply denosumab biosimilars,…
June 11, 2026

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NEWS

Xbrane and JOINN Biologics Partner to Develop Xdarzane (Biosimilar, Darzalex) 

Shots:  Xbrane Biopharma and JOINN Biologics have entered a strategic partnership to provide customized development services for Xdarzane, a biosimilar version of Darzalex (daratumumab)  Under the agreement, JOINN will advance Xdarzane through pilot-scale process development, analytical similarity studies, and process optimization for commercial manufacturing. Xbrane will lead global out-licensing efforts, while both companies will collaborate on further development, scale-up, clinical studies, regulatory filings, and commercialization …
June 11, 2026

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