Tagged as: Biosimilars News

Samsung Bioepis and Genentech Settle Trastuzumab Biosimilar Patent Disputes

On June 28, 2019, Samsung Bioepis and Genentech filed a joint stipulation of dismissal of their BPCIA patent litigation concerning ONTRUZANT (trastuzumab-dttb), Samsung Bioepis’s biosimilar of HERCEPTIN that received FDA-approval earlier this year.  According to the stipulation, the parties “have entered into a settlement agreement, and mutually agree to voluntarily dismiss…

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FDA Approves Fifth Biosimilar of HERCEPTIN

Today, June 13, 2019, the U.S. FDA approved Amgen’s aBLA for KANJINTI (trastuzumab-anns), a biosimilar of Genentech’s HERCEPTIN. According to its approved package insert, KANJINTI, like its reference product, is indicated for the treatment of HER2 overexpressing breast cancer and the treatment of HER2 overexpressing metastatic gastric or gastroesophageal junction…

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Prescription Drug Prices Continue to Rise Despite Generics and Biosimilars

A recent analysis reveals that prescription drug prices continue to increase — even for drugs with FDA-approved therapeutic equivalents or biosimilar products. Dr. Nathan Wineinger evaluated the change in prescription drug prices over a 6-year period for the 49 top-selling brand-name medications in the United States. The price of 48…

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The Biologic Patent Transparency Act: Proposed Revisions to Purple Book

Earlier this month, a bipartisan group of six senators introduced the Biologic Patent Transparency Act (“BPTA”), which the senators say will “help increase patent transparency, promote biosimilar competition, bring needed biosimilar treatments to patients faster, and ultimately, lower drug prices for consumers.” The sponsors further state that the bill will…

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Court Enters Preliminary Injunction Against JHL In Biosimilar Trade Secrets Case

As we previously reported, in October 2018, Genentech brought claims against Taiwan-based biosimilar developer JHL Biotech, Inc. and individual defendants for trade secret misappropriation, computer fraud, breach of contract, and other claims.  The alleged trade secrets relate to several of Genentech’s products: Rituxan® (rituximab), Herceptin® (trastuzumab), Avastin® (bevacizumab), and Pulmozyme®…

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