Search Results: test Interchangeability

New Data Supports Efficacy and Safety of Boehringer Ingelheim's Cyltezo, a Humira Biosimilar

Today, Boehringer Ingelheim announced new one-year data for their adalimumab biosimilar, Cyltezo®.  VOLTAIRE®-RA, a 48 week Phase III clinical trial, compared Cyltezo® (adalimumab-adbm) to Humira.  The results showed that Cyltezo® has equivalent efficacy, safety, and immunogenicity to Humira.  The data also showed consistent results when patients were switched to Cyltezo® from the reference product. …

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Ireland's Department of Health is Requesting Comments Regarding its National Biosimilars Medicines Policy

Ireland’s Department of Health (the “Department”) recently reported on its website that it is “developing a National Biosimilar Medicines Policy to promote the use of biosimilar medicines and to create a sustainable environment for biological medicines in Ireland.”  The Department is now asking the public for its views regarding the…

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FDA Issued Draft Guidance on Interchangeability

BioSimilars Patent Dance

Today, the FDA announced the availability of a draft guidance on biosimilar interchangeability, entitled “Considerations in Demonstrating Interchangeability With a Reference Product,” which is currently available on FDA’s website.  The official announcement is scheduled to be published in the Federal Register tomorrow, January 18, 2017. This guidance provides an overview…

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Regulators Highlight Differing International Biosimilar Regulations; Interchangeability Guidance May Slip to 2017

Bloomberg BNA reported that a panel of regulators at the DIA 2016 Biosimilar Conference in Washington highlighted the differences among biosimilar regulations internationally and the ongoing changes as countries revise their biosimilar guidances. For instance, in Canada, biosimilars are regulated as new biologics as opposed to the U.S.’s abbreviated pathways…

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FDA to Issue Draft Guidance on Interchangeability by End of Year

Last Thursday, October 20, the FDA held a scheduled public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA).  The FDA heard from a wide spectrum of stakeholders, including patient/public health advocates, healthcare professionals, and industry representatives.  As we previously reported, the FDA had committed to publishing a draft…

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FDA BsUFA Goals Letter Outlines Plans for Guidance, Pushes Back Timeline on Interchangeability Guidance

FDA has published its performance goals and procedures (commonly referred to as FDA’s “goals letter” or “commitment letter”) for the Biosimilar Biological Product User Fee Act (“BsUFA”) reauthorization for fiscal years 2018 – 2022, ahead of its upcoming public meeting on October 20, 2016 to discuss FDA’s proposed recommendations for the BsUFA reauthorization….

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