On January 15, 2018, Swedish company XBrane Biopharma issued a press release stating that, in December 2017, it signed a non-binding letter of intent with Chinese company CR Pharma regarding XLucane, a ranibizumab biosimilar. According to the press release, XBrane and CR Pharma intend to take Xlucane to market in China,…
We previously posted that Coherus had filed a motion to stay discovery in Amgen v. Coherus (involving pegfilgrastim) pending resolution of Coherus’s motion to dismiss. On September 13, Coherus withdrew its motion to stay. The court subsequently entered a scheduling order, setting a 5-day trial starting September 16, 2019. Meanwhile,…
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…
According to a May 7, 2017 record on ClinicalTrials.gov, Celltrion is conducting a Phase 1/3 clinical trial to evaluate efficacy and safety between a subcutaneous biosimilar of infliximab (“CT-P13 SC”) with its currently marketed intravenous infliximab product (“CT-P13 IV”) in patients with rheumatoid arthritis. An earlier August 25, 2016 record on ClinicalTrials.gov…
BioCND, a South Korean biopharmaceutical company, announced on Monday that it will begin clinical development in Korea of ranibizumab, a biosimilar of Genentech’s Lucentis® injection for patients with wet age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), and diabetic macular edema (DME). Globally, other companies have already…
On December 16, 2016, Genentech filed preliminary responses in IPR2016-01693 and IPR2016-01694. Mylan filed both IPR petitions in August against patent 6,407,213, which covers humanized antibody polypeptides and methods for their preparation and use. The patent does not focus on any particular therapy, but Genentech notes that the approach was used to develop Herceptin®,…
On August 16, bioeq filed a petition for inter partes review of U.S. Patent No. 6,716,602, titled “Metabolic rate shifts in fermentations expressing recombinant proteins.” The patent is owned by Genentech and is directed to a method for increasing product yield of a polypeptide produced by recombinant host cells. We will…
According to a press release, Novartis AG has contracted Jacobs Engineering Group Inc. to provide engineering, procurement, and construction management services to expand monoclonal antibody (mAb) production capacity by 70% and to establish a purification system that would allow parallel manufacturing of multiple drugs at the Novartis Pharma S.A.A. Biotechnology…