On Monday April 17, 2023, Celltrion announced that it has launched VEGZELMA (bevacizumab-adcd, an AVASTIN biosimilar) in the United States for the treatment of several cancers, including metastatic colorectal cancer and breast cancer. As we previously reported, VEGZELMA was approved by the U.S. Food and Drug Administration in September 2022…
As we previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding on an expedited schedule, with a two-week trial scheduled to begin on June 12, 2023, less than a year from Regeneron’s filing of its complaint in August 2022. The Court’s scheduling order, issued in October…
On April 10, 2023, Celltrion confirmed the bioequivalence of CT-P39 to treat allergic asthma and chronic urticaria, through its interim results from its global phase 3 clinical trials at 24 weeks. CT-P39 is a biosimilar referencing Xolair (ingredient: omalizumab), which is an antibody biopharmaceutical that treats allergic asthma, chronic urticaria,…
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…
In 2017, three indirect-purchaser antitrust class actions were filed against Johnson & Johnson and Janssen Biotech, Inc., alleging that they engaged in anticompetitive conduct relating to the sale and marketing of J&J’s REMICADE (infliximab). The class actions were brought by employee welfare benefit plans, specifically the National Employees Health Plan,…
Last week, Arbutus Biopharma Corp. and Genevant Sciences GmbH (collectively, Arbutus) filed a complaint for patent infringement in the District of New Jersey against Pfizer, Inc. and BioNTech SE. Arbutus/Genevant allege that Pfizer/BioNTech’s COVID-19 vaccine and any COVID-19 mRNA LNP vaccine products infringe five Arbutus/Genevant patents “relating to nucleic acid-lipid…
On April 27, 2023, Matt Wetzel, Life Sciences Partner at Goodwin, will lead a webinar to address the latest updates on the Inflation Reduction Act and the law’s sweeping changes to how the government intends to pay for pharmaceuticals and biologics. The new Medicare price negotiation program, inflation-based rebates, and…
On April 5, 2023, Goodwin’s Matt Wetzel and Heath Ingram published a client alert addressing the initial guidance memorandum issued by the Centers for Medicare & Medicaid Services (CMS) on the Medicare Drug Price Negotiation Program created by the Inflation Reduction Act of 2022. Public comments are due to CMS…
On April 3, 2023, Celltrion announced positive 24-week results from its global Phase III Clinical Trial of CT-P42 (aflibercept), a biosimilar referencing Regeneron’s EYLEA. The trial is a 52-week trial in 348 patients with diabetic macular edema (DME) across thirteen countries. The primary endpoint was the change in best corrected…
In a report entitled “Bold Goals for U.S. Biotechnology and Biomanufacturing,” the White House recently announced several biotech-related “bold goals” to advance the environmental, agricultural, economic, health, and science fields. The publication follows President Biden’s Sept. 12, 2022 Executive Order on “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe,…