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NEWS

Alvotech Reports the US FDA’s BLA Resubmission for AVT05 (Bisomilar, Simponi and Simponi Aria) and AVT06 (Biosimilar, Eylea)

Shots: The US FDA has received resubmitted BLA of AVT05, a biosimilar version of Simponi & Simponi Aria, and AVT06, a biosimilar to Eylea 2mg (aflibercept)  Resubmissions follow Alvotech’s response to the FDA’s PAAL regarding its Reykjavik facility, alongside responses to observations from a May 2026 routine cGMP inspection & ongoing enhancements to quality systems…
June 4, 2026

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NEWS

Polpharma Biologics Partners with PSI CRO to Conduct a P-I  Clinical  Trial  Evaluating PB018 (Biosimilar, Ocrevus) 

Shots:  Polpharma Biologics has partnered with PSI CRO to advance a P-I clinical trial evaluating PB018, its proposed biosimilar to Ocrevus (ocrelizumab), in multiple sclerosis pts, with the study expected to begin in October 2026  The randomized P-I study will enroll approximately 222 participants to compare the PK, PD, safety, and immunogenicity of PB018 with Ocrevus, with PK…
June 3, 2026

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NEWS

Chime Biologics & Daewoong Partner to Develop and Commercialize of Dupilumab (Biosimilar, Dupixent) in Global Markets 

Shots:  Chime Biologics and Daewoong Pharmaceutical signed a strategic partnership to develop and manufacture a biosimilar version of Dupixent  Chime Biologics will support Daewoong's global biosimilar ambitions with its end-to-end development expertise, AI platform, and China's bioprocess supply chain ecosystem  Dupilumab (Dupixent) is a mAb that blocks IL-4 and IL-13 signaling to treat Type 2 inflammation  Ref: Chime Biologics |   Image: Chime Biologics and Daewoong Pharmaceutical | Press Release Related…
June 2, 2026

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Celltrion
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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…
June 1, 2026

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NEWS

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…
May 22, 2026

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NEWS

Samsung Bioepis Introduces its Ustekinumab Biosimilar in Japan with NIPRO CORPORATION

Shots: Samsung Bioepis has reported the launch of Ustekinumab BS 45 mg Syringe for SC Injection 「NIPRO」, a biosimilar version of Stelara, in Japan, marking the company’s first commercialized product in the country The biosimilar will be commercialized by NIPRO CORPORATION under a strategic partnership between Samsung Bioepis & NIPRO in 2025, focused on developing &…
May 20, 2026

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NEWS

Formycon and Klinge Biopharma Launch FYB203 (Biosimilar, Eylea) in the EU 

Shots:  Formycon and licensing partner Klinge Biopharma have reported the EU launch of FYB203, a biosimilar version of Eylea 2mg (aflibercept)  FYB203 is now available in the EU as a PFS under the brand names Ahzantive and Baiama. The launch began on May 15, 2026, in key markets including Germany, France, and Italy, with further expansion across Central and Eastern Europe planned…
May 19, 2026

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