On September 15, Boehringer Ingelheim (BI) and Samsung Bioepis each issued a press release announcing that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion regarding a biosimilar product for which the company is seeking European marketing approval. BI’s…
The PTAB has been a busy place for biologics patents in the past few weeks. Here are some of the highlights: On August 29, Pfizer filed two petitions for IPR of Genentech’s U.S. patents related to formulations of Herceptin® (trastuzumab): IPR2017-02019 on U.S. Patent 6,339,142 and IPR2017-02020 on U.S. Patent 9,249,218….
At the European Society for Medical Oncology (“ESMO”) 2017 Congress, which was held over the past several days in Madrid, Spain, companies presented Phase 3 clinical data regarding two investigational biosimilars of Herceptin (trastuzumab). First, Amgen presented Phase 3 study data on ABP980, which it is co-developing with Allergan plc, comparing the safety…
Samsung Bioepis has filed three petitions for IPR challenging Genentech patents related to the use of Herceptin® (trastuzumab): IPR2017-01958, challenging U.S. Patent 6,627,196; IPR2017-01959 challenging U.S. Patent 7,371,379; and IPR2017-01960 challenging U.S. Patent 7,892,549. Samsung Bioepis concurrently filed motions for joinder with Hospira’s petitions challenging the same patents (IPR2017-00804, IPR2017-00805, and…
Yesterday, two groups announced the submission of applications seeking FDA approval of biosimilars of Herceptin® (trastuzumab), which is indicated for the treatment of HER2-positive early breast cancer, adjuvant breast cancer, metastatic breast cancer and metastatic gastric cancer. First, Celltrion and Teva announced that the FDA has accepted for review a BLA…
The FDA Oncologic Drugs Advisory Committee (ODAC) unanimously supported biosimilar versions of Roche’s cancer drugs Avastin (bevacizumab) and Herceptin (trastuzumab). Amgen and Allergan’s Avastin biosimilar candidate, ABP 215, was reviewed for six of eight of Avastin’s indications. Mylan and Biocon’s Herceptin biosimilar candidate, MYL-1401O, was reviewed for all of Herceptin’s indications….
Pfizer has filed two petitions for IPR of U.S. Patent 8,591,897, owned by Genentech: IPR2017-01726 and IPR2017-01727. According to the petitions, the ‘897 patent is directed to methods for treating patients with non-metastatic HER2-positive breast cancer by administering anthracycline/cyclophosphamide (AC) based chemotherapy, followed by sequential administration of a taxoid and…
The FDA announced today that the Oncologic Drugs Advisory Committee will hold a public meeting on July 13, 2017 in Silver Springs, Maryland to discuss two biosimilar applications. During the morning session, the committee will discuss Amgen’s application for a proposed biosimilar of Genentech/Roche’s AVASTIN (bevacizumab). During the afternoon session, the…
Earlier this week, Celltrion filed two petitions for inter partes review of Genentech’s U.S. Patent No. 6,407,213. According to Celltrion’s petitions, the patent is directed to humanized antibodies. Mylan previously challenged the same patent in two IPR petitions, which terminated in settlement with Genentech. We will continue to monitor and report…
To view our full FDA Approvals tracking table, click here. Last updated: March 31, 2026