Skip to content Skip to footer
Subscribe Now
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

Read more

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

Read more

Celltrion
NEWS

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

Read more

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

Read more

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

Read more

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

Read more

NEWS

Accord BioPharma Reports the US FDA Approval of Immgolis and Immgolis Intri (Biosimilar, Simponi and Simponi Aria)

Shots: The US FDA has approved Immgolis & Immgolis Intri, the interchangeable biosimilar versions of Simponi & Simponi Aria (golimumab), respectively Immgolis & Immgolis Intri are both approved for the treatment of adults with mod. to sev. active rheumatoid arthritis in combination with methotrexate, while Immgolis is additionally approved for mod. to sev. active ulcerative…
May 19, 2026

Read more

sandoz
NEWS

Sandoz Reports the EC Approval of Bysumlog and Dazparda (Biosimilars, Humalog and NovoRapid)

Shots: The EC has approved Bysumlog & Dazparda, the biosimilar versions of Humalog (insulin lispro) & NovoRapid (insulin aspart), respectively, as prefilled pens Bysumlog is approved for the treatment and initial stabilisation of diabetes mellitus in adults & children, while Dazparda is approved for diabetes treatment in pts (≥1yr.). Both demonstrated equivalent efficacy & comparable…
May 18, 2026

Read more

NEWS

Alteogen Reports the MFDS Approval of Eyzanfy (Biosimilar, Eylea) 

Shots:  The Korean MFDS has approved Eyzanfy (ALT-L9), a biosimilar version of Eylea (aflibercept)  In 2025, ALT-L9 received EC approval as a brand name of Eyluxvi  Approval was based on P-III trial across 12 countries in 431 wAMD pts, demonstrating Eyluxvi’s efficacy, safety, and therapeutic equivalence comparable to Eylea  Ref: Alteogen | Image: Alteogen | Press Release Related News:- Alteogen’s Eyluxvi (Biosimilar, Eylea) Receives the CHMP’s…
May 15, 2026

Read more

Load more