Tagged as: Biosimilars News

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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Biosimilar IPR Appeal Updates

Following the Celltrion and Pfizer settlements of the trastuzumab litigation, the Federal Circuit granted the request of the Director of the PTO to intervene under 35 U.S.C. § 143 (i.e., defend a PTAB decision when a petitioner withdraws on appeal) in the Genentech appeals of final written decisions of unpatentability in Case…

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Health Canada Drops Suffix in Biologic and Biosimilar Naming Convention

Last week, Health Canada announced that biologic drugs, including biosimilars, will be identified “by their unique brand name and non-proprietary (common) name, without the addition of a product-specific suffix. Both the brand name and non-proprietary name should be used throughout the medication use process so that biologics that share the…

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Alvotech Raises US$300 Million To Boost Biosimilar Pipeline

Alvotech announced today that its current product pipeline of “six biosimilar monoclonal antibodies aimed at treating cancer, autoimmune, inflammatory and other diseases” will receive an injection of capital from funds raised through a private bond offering. Having raised US$300 million, Alvotech plan to use the net proceeds “to fuel continued…

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