Tagged as: Trastuzumab

Biocon and Alvotech Release Statements on FDA Inspections

On August 31, 2022, Biocon Biologics released a statement regarding three recent on-site FDA inspections of seven manufacturing facilities spanning two sites in Bengaluru, India and one site in Johor, Malaysia.  The inspections took place between August 11 and August 30, 2022.  The inspections were triggered by three preapproval inspections…

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EMA Recommends Denying Marketing Authorization for Prestige BioPharma’s TUZNUE and HERVELOUS (trastuzumab) (UPDATE – 5/27/2022)

European Medicines Agency

On May 19, 2022, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) issued opinions recommending the refusal of marketing authorization for Prestige BioPharma Ltd.’s HD201, TUZNUE and its duplicate HERVELOUS, proposed trastuzumab biosimilars of Roche’s HERCEPTIN. TUZNUE and HERVELOUS are intended for the treatment of…

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Clinical Trial Updates: Insulin Glargine and Trastuzumab Biosimilars

Lannett Company Announces Initiation of Pivotal Clinical Trial for Biosimilar Insulin Glargine On March 29, 022, Lannett Company (NYSE: LCI) announced the initiation of its pivotal clinical trial of biosimilar insulin glargine, which is being co-developed with Lannett’s strategic alliance partners within the HEC Group of companies. Lannett reported that…

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International Biosimilar Launches: Ujvira and PrInclunox®

On May 24, 2021, Zydus Cadila launched the world’s first antibody drug conjugate (ADC) biosimilar.  The drug is a trastuzumab emtansine biosimilar—using Genentech’s Kadcyla as the reference product—that will be marketed under the name Ujvira for use in treating early and advanced HER2 positive breast cancer.  The drug is made…

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White Paper Investigates Biosimilar Competition and Price Reduction

In March 2021, researchers from Harvard Medical School, Harvard University, and Brigham and Women’s Hospital published a white paper exploring the link between entry of biosimilars under The Biological Price Competition and Innovation Act (BPCIA) and moderation in drug prices driven by market competition.  The white paper studied the price and…

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Biocon Biologics Expands Access to Biosimilars In Over 30 Countries In Africa and Asia

Biocon Biologics, a subsidiary of Biocon, announced today that it has signed an agreement with Clinton Health Access Initiative (CHAI) to develop advanced cancer therapies for patients in 25 countries in Africa and 5 countries in Asia as part of the Cancer Access Partnership (CAP). According to the announcement, Biocon Biologics aims…

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Q4 2020 and Full Year Earnings Roundup: Biologics and Biosimilars Update

Below are some highlights from fourth quarter and full year 2020 earnings reports recently released by biologics and biosimilars companies: At the end of last month, Johnson & Johnson reported fourth quarter sales of $22.5 billion reflecting growth of 8.3% and full year sales of $82.6 billion reflecting growth of…

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