On September 10, 2021, Janet Woodcock, the acting FDA Commissioner of Food and Drugs at the FDA, sent a letter to Andrew Hirshfield, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office (USPTO) “pursuant to Executive Order 14036, and in the hope…
Recently, JHL Biotech co-founders Racho Jordanov and Rose Lin pled guilty and were convicted of conspiring to steal trade secrets related to Genentech’s cystic fibrosis drug Pulmozyme, and cancer drugs Rituxan, Herceptin, and Avastin. Although Jordanov and Lin initially pled not guilty, the former JHL employees later admitted to hiring…
On September 2, 2021, the parties in the Amgen v. Hospira (D. Del., No. 18-1064) Neupogen®/filgrastim litigation submitted a stipulation and proposed order to dismiss all claims and counterclaims in the litigation, with prejudice. The Court (Judge Connolly) has not yet entered the order of dismissal on the docket. The…
Last week, Pfizer announced that it will acquire Trillium Therapeutics, a clinical stage immune-oncology company based in Cambridge, Massachusetts. Under the agreement, Pfizer reported that it “will acquire all outstanding shares of Trillium not already owned by Pfizer for an implied equity value of $2.26 billion, or $18.50 per share,…
Last week, Bio-Thera Solutions and Hikma Pharmaceuticals announced they have entered into an exclusive commercialization and license agreement to commercialize the proposed ustekinumab biosimilar product, BAT2206. According to the press release, Bio-Thera will “maintain responsibility for development, manufacturing, and supply of BAT2206 [and] Hikma will have exclusive rights to commercialize…
On August 18, 2021, Fresenius Kabi USA, LLC and Fresenius Kabi SwissBioSim GmbH (collectively, “Fresenius”) filed Petitions for Inter Partes Review of U.S. Patent No. 10,874,677 (IPR 2021-01336) and U.S. No. 5,80,264 (IPR 2021-01288) . The ‘264 patent claims are directed to methods of treating rheumatoid arthritis patients using a…
Last week, Enzene Biosciences announced that it has received marketing authorization from the Drug Controller General of India (DCGI) for its biosimilar product romiplostim. The product will be offered in three dosage strengths and is indicated for the treatment of chronic Immune Thrombocytopenic Purpura (ITP) in adults. ITP is a…
On July 29, 2021, the American Academy of Ophthalmology (AAO) released a statement urging the Centers for Medicare & Medicaid Services (CMS) to prohibit Insurance companies from requiring ophthalmologists to use new biosimilar drugs as alternatives to Avastin for treatment in eye diseases. The statement alleges that certain large healthcare…
It has been reported that U.S. pharmacy benefit manager CVS will drop Sanofi’s insulin drugs, Lantus® (insulin glargine injection, 100 units/ml) and Toujeo® (insulin glargine injection, 300 units/ml) from the list of medications for which it reimburses on behalf of health insurers. In July CVS caremark® published a list of…
Last week, FDA announced the Biosimilar User Fee Act (BsUFA) rates for the 2022 fiscal year, which runs from October 1, 2021 through September 30, 2022. The FDA determined these rates pursuant to the Food and Drug Administration Reauthorization Act (FDARA), which was signed into law on August 18, 2017….