Tagged as: Clinical Trial

Biosimilar Clinical Updates

Over the past two weeks, there have been a number of announced clinical studies and updates from biosimilar developers around the world. On November 9, Shanghai based Henlius Biotech, Inc. announced the start of its Phase I clinical trial of HLX14, the company’s biosimilar to Prolia® (denosumab).  According to the…

Read More

EYLEA (Aflibercept) Biosimilar Development Updates (Part 2)

Regeneron’s EYLEA (aflibercept) was approved by the U.S. FDA on November 18, 2011 and is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). As previously reported, Momenta in collaboration with Mylan began…

Read More

Biosimilars Update: Bio-Thera Solutions BAT1706 (bevacizumab) and Pfizer RUXIENCE (rituximab)

Below are a few biosimilar-related updates from the past week. Bio-Thera Solutions announced that in a Phase III clinical trial of BAT1706 (bevacizumab), BAT1706 met its primary endpoint, demonstrating “equivalence in overall response rate (ORR) for the first-line treatment of patients with non-squamous non-small cell lung cancer.”  Bio-Thera indicated that…

Read More

Biosimilar Clinical Trial Updates

Below are highlights of recent developments in biosimilar clinical trials. On December 9, Celltrion presented the results from a phase 3 clinical trial that demonstrated similar safety and efficacy of its TRUXIMA biosimilar to the reference product RITUXAN (rituximab) in patients with advanced follicular lymphoma (AFL). On December 10, Samsung…

Read More

Clinical Trial Announcements

This week, several companies reported updates in their clinical development of biosimilars or follow-on biologics. On December 3, Outlook Therapeutics (formerly known as Oncobiologics) announced the FDA agreed with three of Outlook’s proposed Special Protocol Assessments (“SPAs”) relating to ONS-5010, an investigational ophthalmic formulation of bevacizumab which is currently in…

Read More

NeuClone Commences Human Dosing of Biosimilar Trastuzumab in Phase I Clinical Trial

Last week, NeuClone Ltd. announced it commenced its Phase I clinical trial for its biosimilar Herceptin® (trastuzumab).  According to NeuClone, the Phase I trial is a single-dose, randomized, three-arm double blind study of over 100 healthy volunteers, conducted under the Australian Clinical Trial Notification (CTN) scheme.  According to NeuClone, “[t]his…

Read More

Biosimilar Clinical Trial Updates

Earlier this month, Clover Biopharmaceuticals, Celltrion, and JHL Biotech provided updates on their respective biosimilar clinical trials.  A summary of these developments is below. Clover Biopharmaceuticals announced the beginning of their Phase 1 trial of SCB-808, a proposed biosimilar to Enbrel (etanercept).  According to Clover, the trial is designed to…

Read More

Glenmark Reports Positive Phase 1 Results on Biosimilarity of GBR 310 to Omalizumab

Glenmark Pharmaceuticals announced positive results in a Phase 1 study comparing biosimilar GBR 310 to omalizumab, marketed as Xolair® by Genentech and Novartis.  According to Glenmark, the study supports similarity in pharmacokinetic, pharmacodynamic, safety, and immunogenicity profiles. Xolair® is an anti-IgE antibody indicated for treating certain patients with either moderate…

Read More

Paper reports on administration of adalimumab biosimilar using an autoinjector

Earlier this month, the journal of Expert Opinion on Drug Delivery published results from a clinical study of BI 695501, an adalimumab biosimilar, using an autoinjector (AI).  BI 695501 is a self-injectable adalimumab biosimilar that according to the publication has “demonstrated PK bioequivalence and similar clinical efficacy, safety, and immunogenicity with…

Read More