On January 15, 2020, the Romanian Competition Council fined fined Roche Romania SRL €12.9 million ($14.2 million) following two investigations into what the Competition Counsel found to be Roche’s anti-competitive practices related to its cancer drugs. In the first investigation, the Competition Council found that between 2017 and 2019 Roche…
On February 28, 2019, the FDA approved Genentech’s Herceptin Hylecta (trastuzumab and hyaluronidase-oysk). According to a press release from Roche, Genentech’s parent company: “This new treatment includes the same monoclonal antibody as intravenous Herceptin® (trastuzumab) in combination with recombinant human hyaluronidase PH20, an enzyme that helps to deliver trastuzumab under…
On December 14, 2018, Prestige Biopharma (“Prestige”) announced a partnership with Cipla Ltd. (“Cipla”) for Prestige’s HD201, a proposed trastuzumab biosimilar of Roche’s Herceptin®. Prestige’s HD201 is in Phase-3 clinical development for the treatment of patients with HER2-overexpressing breast cancer. According to the press release, under the agreement, Cipla will…
Dr. Reddy’s Laboratories Ltd. announced today that it launched HERVYCTA (trastuzumab), a biosimilar of Roche’s HERCEPTIN, in India. According to the press release, HERVYCTA is indicated for the treatment of HER2-positive cancers (early breast cancer, metastatic breast cancer and metastatic gastric cancer), and is available in strengths of 150mg and…
Over the past few weeks, numerous biologics and biosimilar companies released their quarterly earnings for Q1 2018 and held related earnings calls. Below are some highlights: On April 17, Johnson & Johnson (J&J) reported a 22.5% year-over-year (YOY) decline in U.S. sales of Remicade® (infliximab), which it attributed “to increased discounts/rebates,…
Today, the FDA announced that it has approved Mylan’s Ogivri (trastuzumab-dkst) as a biosimilar to Genentech and Roche’s Herceptin (trastuzumab). Ogivri is indicated for adjuvant treatment of breast cancer and treatment of metastatic breast cancer or stomach cancer in patients whose tumors overexpress the HER2 gene. Ogivri is the first biosimilar version…
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….
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….
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…
Mylan announced today that it had reached a settlement with Genentech, Inc. and F. Hoffman-La Roche Ltd. that provides Mylan with global licenses to commercialize its biosimilar to Genentech’s Herceptin® (trastuzumab). As part of the settlement, Mylan agreed to withdraw its IPR challenges to U.S. Pat. Nos. 6,407,213 and 6,331,415….