Tagged as: Trastuzumab

Biocon Completes Integration of Viatris Biosimilars Business

As we previously reported, in December 2022, Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) had completed acquisition of the global biosimilars business of its long-term partner Viatris, Inc.  This week Biocon announced that it had “completed the integration of the acquired biosimilars business in over 70 countries in Emerging…

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Accord BioPharma Announces the Acceptance of BLA for HLX02 (a proposed trastuzumab biosimilar) by FDA

On April 5, 2023, Accord BioPharma announced that the FDA has accepted the Biologics License Application (BLA) for HLX02 referencing HERCEPTIN (trastuzumab) for adjuvant treatment of HER2-overexpressing breast cancer and treatments of HER-2 overexpressing metastatic breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma. The BLA submission included results from…

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Genentech BPCIA Trastuzumab Case Against Tanvex Dismissed After Settlement

As previously reported, Genentech and Tanvex reached an agreement in January 2022 to settle BPCIA litigation relating to Tanvex’s biosimilar of HERCEPTIN (trastuzumab).  On February 9, the court entered an order dismissing all claims in the case.  Tanvez’s trastuzumab biosimilar has not yet been approved by FDA. Genentech previously settled…

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Biosimilar Clinical Trial Updates

Big Molecule Watch monitors for biosimilar clinical trial results. Here we report on four recent announcements concerning biosimilars of natalizumab, trastuzumab, daratumumab, and aflibercept. On January 23, 2023, researchers published the results of a phase III clinical trial demonstrating that PB006, Polpharma Biologics SA’s biosimilar to Biogen’s approved treatment TYSABRI®…

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Genentech and Tanvex Reach Settlement in Principle in Trastuzumab BPCIA Litigation

On January 6, 2023, Genentech and Tanvex reached a settlement in principle to resolve all claims with respect to Genentech’s BCPIA complaint.  As we previously reported, Genentech filed a complaint against Tanvex in June 2022, alleging infringement of three patents under the BPCIA based on Tanvex’s submission of an aBLA…

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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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