Skip to content Skip to footer
Subscribe Now

NEWS

Lupin Receives US FDA Approval for Ranluspec (Biosimilar, Lucentis) 
Shots:  The US FDA has approved Ranluspec (ranibizumab-hkdz), a biosimilar version of Lucentis (ranibizumab)  Ranluspec is an interchangeable ranibizumab biosimilar approved in the US, available in both vials and PFS at 0.3 mg (0.05 mL of 6 mg/mL) and 0.5 mg (0.05 mL of 10 mg/mL) strengths, matching Lucentis  It is a recombinant humanized IgG1 mAb fragment that inhibits VEGF-A and is indicated for wet age-related macular degeneration,…
June 5, 2026
Henlius Reports First US Patient Dosed in Global P-I Trial of HLX17 (Biosimilar, Keytruda) 
Shots:  Shanghai Henlius has dosed the first US patient in the global P-I trial of HLX17, a biosimilar version of Keytruda (pembrolizumab), for the adjuvant treatment of multiple resected solid tumors  P-I multicentre study evaluates the PK, efficacy, safety, and immunogenicity of HLX17 vs Keytruda in pts with resected solid tumors, including non-small cell lung cancer, melanoma, and renal cell carcinoma.…
June 5, 2026
Teva Launches Ahzantive (Biosimilar, Eylea) Across Key EU Markets
Shots: Teva has launched Ahzantive, a biosimilar version of Eylea, in EU, with pre-filled syringe launches beginning in May 2026 in France, Germany, Spain, & the Netherlands, and additional market launches planned later in 2026 Ahzantive received EC approval in 2025 for the treatment of wet age-related macular degeneration, diabetic macular edema, visual impairment due…
June 5, 2026
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
Lundbeck Partners with Cradle to Accelerate AI-Driven Biotherapeutics Discovery
Shots: Lundbeck and Cradle entered a partnership to leverage AI-powered protein engineering for the discovery and optimization of biotherapeutics, with an initial focus on 2 antibody programs targeting CNS diseases Lundbeck will deploy Cradle’s generative AI platform in its first end-to-end AI-guided protein engineering workflow, using iterative feedback from experimental data to discover & optimize…
June 4, 2026
CytomX and Regeneron Expand Tumor-Activated Bispecific Cancer Therapy Collaboration in Potential ~$4B Deal
Shots: CytomX has expanded its collaboration & licensing agreement with Regeneron to develop conditionally-activated bispecific cancer therapies using CytomX’s Probody platform & Regeneron’s Veloci-B BsAb development platform As per the expanded deal, the companies will continue joint discovery efforts to identify & validate conditionally active BsAbs, with Regeneron assuming responsibility for all preclinical & clinical development, commercialization,…
June 4, 2026
Load more