Tagged as: biosimilars

An Interview with Prof. Arti Rai about the Role of “Patent Thickets” in U.S. Biosimilar Market Entry

Last week, Big Molecule Watch sat down with Professor Arti Rai to discuss an article she recently co-authored, “How logically impossible patents block biosimilars.” The article, published earlier this month in the journal Nature Biotechnology, examines the differences between the patent and drug approval legal and regulatory regimes and how…

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Biosimilar and Follow-On Biologic Development Updates

Below are some highlights of recent news in biosimilar and follow-on biologic development: Prestige BioPharma On July 2, Prestige BioPharma (Prestige) licensed the rights to Tuznue, its trastuzumab biosimilar of Roche’s Herceptin, to Mundipharma in selected European markets. The European Medicines Agency (EMA) recently accepted a Marketing Authorisation Application for…

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Bevacizumab Litigation Update: Pfizer Answers Genentech’s Complaint and Genentech Moves to Dismiss Counterclaims

On April 29, 2019, Pfizer answered Genentech’s complaint alleging infringement of 22 patents based on Pfizer’s submission of an aBLA seeking U.S. FDA approval of a biosimilar of Avastin® (bevacizumab).  In its answer, Pfizer denied Genentech’s allegations of patent infringement and violations of the BPCIA’s patent dance procedures.  Pfizer also…

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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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Sandoz Initiates Declaratory Judgment Action Against Amgen Concerning Manufacturing of Filgrastim and Pegfilgrastim Biosimilars

On February 21, 2019, Sandoz initiated a lawsuit against Amgen in the Northern District of California seeking a declaration that its biosimilar filgrastim and pegfilgrastim products do not infringe the Amgen’s ’997 patent. The ’997 patent relates to a method of protein purification and is in the same patent family…

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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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Kashiv Pharma Acquires Adello Biologics and Becomes Kashiv BioSciences

Yesterday, Kashiv Pharma, LLC announced its acquisition of the assets of Adello Biologics, LLC, a biotechnology company developing biosimilars.  Kashiv will now be known as Kashiv BioSciences, LLC with its headquarters in Bridgewater, New Jersey.  It also has research and development and manufacturing facilities in Bridgewater, New Jersey, Piscataway, New…

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