Search Results: Biosimilar News

Regeneron Sues Celltrion For Proposed Biosimilar of Eylea in West Virginia District Court

Regeneron filed a Complaint on November 8 against Celltrion in the U.S. District Court for the Northern District of West Virginia, alleging infringement of thirty-eight patents under the BPCIA based on Celltrion’s submission of an aBLA for CT-P42, a proposed biosimilar of EYLEA (aflibercept), and Celltrion’s provision of Notice of…

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Regulatory Update on Alvotech’s AVT02, a High-Concentration Interchangeable Adalimumab Biosimilar

On September 20, Alvotech announced that FDA has accepted the resubmission of its Biologics License Application (BLA) for AVT02, a high concentration, interchangeable biosimilar to HUMIRA (adalimumab). FDA has set a Biosimilar User Fee Act (BsUFA) goal date for approval of the resubmitted AVT02 BLA of February 24, 2024.  As…

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Sandoz Announces New Data For Its Adalimumab And Rituximab Biosimilars

On November 14, 2017, Sandoz announced data from four clinical trials comparing its proposed adalimumab and rituximab biosimilars to their reference drugs, Humira® and Rituxan®.  We previously reported that the Sandoz adalimumab biosimilar is currently under EMA review.  As we reported here, the Sandoz rituximab biosimilar has been approved by the European Commission…

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Momenta’s Orencia (abatacept) biosimilar candidate M834 does not meet primary endpoints in Phase I study

Yesterday, Momenta and Mylan reported that initial results obtained from their proposed abatacept biosimilar M834 did not meet primary pharmacokinetic endpoints in a Phase I study comparing the pharmacokinetics, safety and immunogenicity of M834 to US- and EU-sourced ORENCIA in 243 normal healthy volunteers. The Phase I study was a randomized,…

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FDA Releases Biosimilars Educational Materials

On October 23, 2017, FDA announced the release of new educational materials to help health care professionals understand what biosimilars are and how they are approved.  The materials include four fact sheets and graphics that provide definitions for relevant terminology, describe the biosimilar approval process, and explain the benefits of biosimilars.  FDA also created social media posts for external…

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Intas Launches Bevatas (bevacizumab) in India

Intas, an Indian pharmaceutical company based in Ahmedabad, has launched BEVATAS (bevacizumab), a biosimilar to Roche’s AVASTIN, in India.  Bevacizumab is used to treat colorectal cancer, ovarian cancer, cervical cancer, lung cancer and recurrent glioblastoma. Bevacizumab has been available in India since 2004. Intas’s BEVATAS product is priced at 40%…

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