Tagged as: Herceptin

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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Celltrion’s CT-P6 Demonstrates Equivalent Safety, Efficacy With HERCEPTIN

A recently-published study reported that Celltrion’s CT-P6 (HERZUMA, trastuzumab-pkrb) demonstrated equivalent safety and efficacy compared with reference drug HERCEPTIN when used to treat patients with HER2-positive advanced gastric cancer.  This is the first study to directly compare the safety and efficacy of CT-P6 against HERCEPTIN in patients with advanced gastric…

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JAMA Oncology Publishes Results of Phase III Study for Prestige BioPharma’s HERCEPTIN Biosimilar, HD201

On March 14, 2022, Prestige BioPharma Ltd., a Singapore-based biopharmaceutical company, announced positive safety and efficacy results in a Phase III study (“TROIKA”) for HD201, a biosimilar to HERCEPTIN (trastuzumab). The results of the TROIKA study were published in JAMA Oncology on March 3, 2022. In the double-blind trial, researchers…

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