Bio-Thera Solutions announced that a phase 3 clinical trial comparing the efficacy and safety of its bevacizumab biosimilar, BAT1706, to the reference product (Avastin), returned positive top-line results.
Bio-Thera Solutions announced that a phase 3 clinical trial comparing the efficacy and safety of its bevacizumab biosimilar, BAT1706, to the reference product (Avastin) returned positive top-line results.
The Chinese commercial-stage biopharmaceutical company said in a press release that BAT1706 proved equivalent to bevacizumab in overall response rate as a first-line treatment for non-squamous non-small cell lung cancer.
“We are pleased to report on our second proposed biosimilar with positive study results,” said Shenfeng Li, PhD, the chief executive officer of Bio-Thera Solutions. “These results demonstrate the potential of our proposed bevacizumab biosimilar to be a safe and effective treatment option for cancer patients. Bio-Thera is committed to increasing patient access to innovative medicines through the development of high-quality biosimilars.”
Avastin is indicated in the US to treat metastatic colorectal cancer, non-squamous non-small cell lung cancer, persistent, recurrent, or metastatic cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer, along with other conditions.
According to the press release, “BAT1706 works by binding the vascular endothelial growth factor (VEGF) protein.” It has not yet received regulatory approval in any country.
The trial consisted of a multicenter, randomized, double-blind study which evaluated the pharmacokinetics and immunogenicity of BAT1706. Results of the study have yet to be released and the company is developing several other proposed biosimilars including ustekinumab, secukinumab and golimumab.
Separately this week, the FDA requested data for Formycon’s Lucentis biosimilar candidate FYB201, as part of a review process for a biologics license application (BLA). The company stated it will take around 4 months to generate the additional data. However, Bioeq, its licensing partner, announced it would withdraw its BLA for the biosimilar candidate, provide requested data, and resubmit the application after, which may delay approval of the BLA.
Cordavis Report Outlines Strategies for Biosimilar Development, Access in the US Health Care Market
May 8th 2024Cordavis, a CVS Healthspire company, released a report detailing the current hurdles faced in developing and commercializing biosimilars in the US and highlighting efforts by the organization to enhance access and affordability for these products.
Biosimilars Policy Roundup for April 2024—Podcast Edition
May 5th 2024On this episode of Not So Different, The Center for Biosimilars® glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.
Review: Product Attributes Relevant to Injection-Site Pain, Adalimumab Treatment
May 4th 2024A review article summarizes the product attributes of reference and biosimilar adalimumab products, such as formulation with or without citrate, delivery volume, and needle gauge, relevant to patients’ experience of injection-site pain.
Cencora Analysis Shows Differences in Payer Coverage Between G-CSF Biosimilars
May 2nd 2024Data from a Cencora study showed some misalignment in payer coverage of granulocyte colony-stimulating factor (G-CSF) biosimilars, highlighting that while filgrastim biosimilars are often favored over the originator, reference pegfilgrastim still dominates over its biosimilars.