Regeneron’s EYLEA (aflibercept) was approved by the U.S. FDA on November 18, 2011 and is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). As previously reported, Momenta in collaboration with Mylan began…
Samsung Biologics has announced that it may expand its manufacturing capacity at its site in Songdo, Incheon. Launched in 2011, Samsung has three plants housing a total of 364,000 L of mostly stainless-steel bioreactor capacity that, according to Samsung’s CEO, will be fully utilized to capacity by 2022. Samsung’s CEO…
Last week, Almirall signed an agreement with WuXi Biologics to collaborate on multiple bispecific antibodies targeting dermatology conditions, including atopic dermatitis. Almirall’s press release indicated that, “[u]nder the terms of the agreement, Almirall has access to WuXi Biologics’ proprietary antibody platforms including WuXiBody™ to discover multiple novel bispecific antibodies.” This…
Samsung Bioepis Co., Ltd announced today that the FDA has accepted for review an aBLA for SB8, a bevacizumab biosimilar to Roche’s Avastin® product. If approved, SB8 will be commercialized in the US by Merck & Co.
On November 15, the FDA approved Pfizer’s Humira® biosimilar, ABRILADA (adalimumab-afzb). The acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, Sarah Yim, M.D., announced the approval as one of nine new biosimilar products the FDA “has taken action on…
As we previously reported, the parties in the follow-on Amgen v. Apotex BPCIA litigation concerning Apotex’s proposed biosimilars of NEUPOGEN (filgrastim) and NEULASTA (pegfilgrastim) informed the district court on August 8 that they were drafting a stipulation and unopposed motion that would substitute Apotex as a party with a then-unnamed…
Earlier this week, Alvotech announced that it has completed enrollment of its Phase III study of AVT02, its proposed biosimilar of Humira® (adalimumab). The study has enrolled 407 patients with moderate-to-severe chronic plaque psoriasis and will occur across approximately 30 sites in Europe “to compare AVT02 and Humira® in terms…
Coherus announced today that it has executed settlement agreements with AbbVie that grant Coherus global, non-exclusive, royalty-bearing license rights under AbbVie’s intellectual property to commercialize CHS-1420, Coherus’ proposed adalimumab biosimilar. According to the press release, the “global settlements resolve all pending disputes between the parties related to Coherus’ adalimumab biosimilar,” with Coherus’s…
Pfizer announced today that the European Commission has approved its Avastin® (bevacizumab) biosimilar ZIRABEV™ for the treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), advanced and/or metastatic renal cell cancer and persistent, recurrent or metastatic carcinoma…
The European Commission has released a report summarizing the European Commission and the national competition authorities’ work to enforce European Union antitrust and merger rules in the pharmaceutical space. The report notes that, by monitoring the pharmaceutical market to ensure that price competition for pharmaceuticals is not artificially reduced or eliminated, and…