Search Results: test Biosimilar News

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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Federal Circuit Oral Arguments in NYC Today

This week, six Federal Circuit panels will hear oral argument on at various venues in New York City.  Two of today’s oral arguments are in biosimilar cases that we have been closely following on this blog. First, at 10:00 AM, a panel will hear oral argument at the U.S. Court…

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