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FDA’s New Draft Guidance Regarding Biosimilarity and …

WEBOn November 20, 2020, the U.S. Food & Drug Administration (“FDA”) released a Q&A-format draft guidance to address four questions regarding the …

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URL: https://www.biosimilarsip.com/2020/12/08/fdas-new-draft-guidance-regarding-biosimilarity-and-interchangeability/

How the U.S. Compares to Europe on Biosimilar …

WEBUpdated March 8, 2021. FDA has not approved any biosimilars in 2021 after only approving three in 2020. EMA approves second Novolog® (insulin aspartate), fifth Avastin® …

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How the U.S. Compares to Europe on Biosimilar …

WEBUpdated November 15, 2021. FDA and EMA both approve first biosimilar version of Lucentis® (ranbizumab). FDA has approved only two biosimilars in 2021 after only …

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How the U.S. Compares to Europe on Biosimilar …

WEBUpdated October 12, 2020. FDA has only approved two biosimilars in 2020. No biosimilars have launched in the U.S. since April 2020. EMA approves first Novolog® (insulin …

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FDA’s Biosimilar Approvals Accelerate in 2018: How the …

WEBCoherus launches Udenyca TM, a pegfilgrastim biosimilar, in the United States.; Pfizer launches Retacrit®, an epoetin alfa biosimilar, in the United States. FDA …

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How the U.S. Compares to Europe on Biosimilar …

WEBEuropean Medicines Agency approves first two pegfilgrastim biosimilars and another adalimumab biosimilar; Pfizer launches Nivestym TM, a filgrastim biosimilar, in …

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How the U.S. Compares to Europe on Biosimilar …

WEBFDA approves the second Enbrel® (etanercept) biosimilar—no etanercept biosimilar has launched in the United States to date. FDA approves the fourth …

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Boehringer Ingelheim Seeks to Redefine a Biosimilar’s …

WEBBoehringer Ingelheim markets Cyltezo® in 20 mg and 40 mg doses, each administered at a 50 mg/mL concentration. Cyltezo is an approved biosimilar of …

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How the U.S. Compares to Europe on Biosimilar …

WEBEuropean Medicines Agency approves second trastuzumab and third insulin glargine biosimilars; FDA has not approved any biosimilar drug in 2018; Only three of …

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Changes to the Purple Book: Progress in Transparency

WEBThe recently enacted “Purple Book Continuity Act of 2019” went into effect as of June 25, 2021. The FDA must proactively update the Purple Book information every …

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U.S. Biosimilar Launches Accelerate with Five Launches in Q4 2019 …

WEBSince November 2019, biosimilar versions of pegfilgrastim, rituximab, bevacizumab, and trastuzumab have launched in the United States. FDA approved fifth …

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Update: How the U.S. Compares to Europe on Biosimilar Approvals …

WEBEuropean Medicines Agency newly approves two adalimumab biosimilars; U.S. Food & Drug Administration approves first bevacizumab biosimilar; As …

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Congress Takes Aim at Reducing the Cost of Medicine

WEBAuthored and edited by attorneys in Rothwell Figg’s Biologics and Biosimilars Group, Rothwell Figg’s Biosimilars Law Bulletin provides updates, articles, and analyses …

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Biosimilars Will Get Special Names- Suffixes Are Here to Stay

WEBOn March 7, 2019, the U.S. Food & Drug Administration (FDA) released updated draft guidance announcing that it will create special names for biosimilar products to …

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Growing Competition for the World’s Most Profitable Drug as …

WEBDuring the first quarter of 2021, multiple companies launched adalimumab biosimilars as a growing number of biosimilar players marketed their versions of the …

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FDA Proposes Amendment to the Definition of “Biological Product”

WEBThe purpose of the proposed amendment is to clarify the statutory authority under which protein products are regulated. In particular, the proposed amendment will …

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Update: How the U.S. Compares to Europe on Biosimilar Approvals …

WEBAydin Harston combines his love for science and technology with legal expertise to advocate for his clients in all matters necessary to grow, protect, and defend …

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What Pharma Companies Must Do Globally to Benefit From …

WEBCanada implemented its patent term extension program, the Certificate of Supplementary Protection (CSP) framework, on September 21, 2017. The CSP regime …

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House Democrats Seek to Remove Biologics Exclusivity Period …

WEBOn July 11, 2019, more than 110 House Democrats wrote a letter to U.S. Trade Representative Robert E. Lighthizer expressing strong opposition to provisions in the …

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