Today Sandoz filed IPR2018-00002, directed to AbbVie’s U.S. Patent No. 9,512,216. According to the petition, the ’216 patent claims a subcutaneously-administered dosing regimen for the anti-TNF-α antibody adalimumab, the active ingredient in AbbVie’s Humira ® product, to treat moderate to severe chronic plaque psoriasis. This is the second petition Sandoz…
Last week, FDA issued its latest draft guidance on biosimilar products and implementation of the BPCIA. The draft guidance, titled Statistical Approaches to Evaluate Analytical Similarity, “describes the type[s] of information a sponsor of a proposed biosimilar product should obtain” to support a showing of analytical similarity to a licensed…
Amgen has announced that it has settled all pending patent litigation regarding AMJEVITA, its biosimilar version of AbbVie’s Humira® (adalimumab). Amgen reports that AbbVie will grant patent licenses for the use and sale of the product worldwide, on a country-by-country basis. Amgen states that it expects to launch its product in…
As we recently reported, a federal jury awarded Amgen $70 million in damages last week after finding that Hospira’s manufacture of 14 batches of drug substance between 2013 and 2015 was not protected under the safe harbor provisions of 35 U.S.C. § 271(e)(1), that the manufacture of those batches infringed one of…
We previously reported that, according to a May 10, 2017 record on ClinicalTrials.gov, Samsung Bioepis planned to start a Phase 3 clinical trial in September 2017 on SB11, its biosimilar of Roche’s Lucentis® (ranibizumab injection), for the treatment of neovascular age-related macular degeneration. The South Korean Ministry of Food and Drug Safety reportedly approved…
The Journal of the American Medical Association (JAMA) recently published a response to “Obstacles to the Adoption of Biosimilars for Chronic Diseases,” a JAMA article we summarized in the spring. In a letter to the editor from the authors of the article “Biosimilars–Curb Your Enthusiasm,” the authors identified an additional obstacle…
On Friday, Amgen filed a complaint for patent infringement under the BPCIA against yet another developer of a biosimilar of Neulasta® (pegfilgrastim). Amgen has sued Mylan in the Western District of Pennsylvania for infringement of U.S. Patent Nos. 8,273,707 and 9,643,997, which Amgen alleges “claim methods of purifying proteins used…
On September 22, 2017, a Delaware federal jury found that Hospira infringed one of Amgen’s Epogen® (EPO) patents. Hospira maintained that its production of EPO was protected by the safe harbor of 35 U.S.C. § 271(e)(1) which allows for use of patented processes for the purpose of gaining FDA approval. Amgen argued…
Last week, Sandoz announced new data reportedly showing that its proposed adalimumab biosimilar matches the safety and efficacy profile of Humira®. The data was obtained from a long term study of patients with moderate-to-severe chronic plaque psoriasis. As we reported here, Sandoz has filed a Marketing Authorisation Application (MAA) with the…
Last week, the FDA announced the Biosimilar User Fee Act (BsUFA) rates for the 2018 federal fiscal year, which runs from October 2017 through September 2018. The FDA determined these rates pursuant to the Food and Drug Administration Reauthorization Act (FDARA), signed into law on August 18, 2017. Among other things,…