On September 19, 2020, Lotus Pharmaceutical Co., Ltd. (“Lotus”) and Chong Kun Dang Pharmaceutical Corp. (“CKD”) announced that they have entered into a commercialization agreement in connection with CKD’s biosimilar darbepoetin alfa, a second-generation epoetin indicated for the treatment of anemia associated with chronic renal failure. According to Lotus’ press…
IP Litigation Partner and BMW editor, Bill James will be part of the Pre-Suit Exchanges and the BCPIA Tango discussion panel at the Summit on Biosimilars & Innovator Biologics presented by the American Conference Institute, Sept 23 -24. To register please click here.
As biosimilars begin to gain traction in the U.S. pharmaceutical market, the distinct labeling requirements applicable to them are likely to affect product liability litigation in this area, raising implications that are potentially distinct from those applicable to biologics and to small-molecule, generic drugs write Products Litigation and Counseling lawyers…
Last week it was announced that Coherus BioSciences’s pegfilgrastim biosimilar Udencya would be excluded from Express Scripts’s preferred formulary starting January 1, 2021. The pharmacy benefit manager’s preferred Neulasta biosimilars for next year are Mylan’s Fulphila and Sandoz’s Ziextenzo.
Celltrion announced last Friday that it will begin Phase I clinical trials of its Prolia (denosumab) biosimilar (CT-P41) in September. Prolia, marketed and sold by Amgen, is a treatment for glucocorticoid-induced osteoporosis (GIOP) in men and women at high risk of fracture. Celltrion has said it plans to finish Phase…
Last week, Vizient, a healthcare performance improvement company, released its Summer 2020 Drug Price Forecast. In the forecast, Vizient reported on the role of COVID-19 in changing healthcare priorities and affecting spending. Particularly, it advised its member health care groups to hedge against drug price inflation, which it estimated will…
We are pleased to present the first in a series of webinars relating to Goodwin’s Guide to Biosimilars Litigation and Regulation in the U.S. which provides expert guidance and practical know-how for lawyers working in this growing area of the law. The first webinar, So You Want To Make A…
Being ten years in since the enactment of the BPCIA provides us a great opportunity to take a look back at how things have developed in the world of biosimilar over the years. When we founded the Big Molecule Watch blog nearly five years ago, there was not a single…
On February 11, 2020, in the Biogen v. Amgen BPCIA litigation regarding MVASI (bevacizumab-awwb), Amgen’s biosimilar of AVASTIN, Judge Colm Connolly of the Delaware District Court denied most of Genentech’s motion to dismiss Amgen’s affirmative defenses and counterclaims. Amgen had pled counterclaims seeking declaratory judgments that the asserted patents are…
Below are a few biosimilar-related updates from the past week. Bio-Thera Solutions announced that in a Phase III clinical trial of BAT1706 (bevacizumab), BAT1706 met its primary endpoint, demonstrating “equivalence in overall response rate (ORR) for the first-line treatment of patients with non-squamous non-small cell lung cancer.” Bio-Thera indicated that…