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…
Johnson and Johnson announced that it has entered into an agreement to acquire Momenta Pharmaceuticals, Inc. for $6.5 billion. The acquisition gives J&J’s Janssen unit full global rights to Momenta’s nipocalimab (M281), an anti-FcRn antibody designed to treat a number of autoantibody-driven disorders, including generalized myasthenia gravis (gMG), warm autoimmune…
Shanghai Henlius Biotech, Inc. announced on August 14, 2020 the approval of its trastuzumab biosimilar HLX02 by the National Medical Products Administration (NMPA). This same product was approved by the European Commission on July 27th. According to the press release, this is the the first China-developed mAb biosimilar to be…
On Tuesday, August 11, Samsung Biologics announced it will invest $2 billion to build a new pharmaceutical “super plant” in Incheon, South Korea. According to the press release, the new facility is part of Samsung’s long term strategy to maximize its operational efficiency and scale up its development and manufacturing…
Roche has provided an update on its phase III study program comprising four Phase 3 trials evaluating the investigational medicine etrolizumab in people with moderately to severely active ulcerative colitis. These trials are titled HIBISCUS I, HIBISCUS II, HICKORY, and . Roche has reported that in the HIBISCUS I induction…
On August 10, 2020, Equillium, Inc. announced its interim data for its study of itolizumab as a first-line treatment in patients with acute graft-versus-host disease (GVHD). GVHD is a multisystem disorder that is a common complication of allogeneic hematopoietic stem cell transplants, and is the leading cause of non-relapse mortality…
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…
Today Alvotech and Teva announced that they have entered into an exclusive strategic partnership for the commercialization of five biosimilar candidates in the U.S. Under the partnership agreement, Alvotech will be responsible for the development, registration and supply of the biosimilars, and Teva will be exclusively commercializing the products in…
Celltrion recently announced that its trastuzumab biosimilar, Herzuma, has met the World Health Organization’s (WHO) prequalification standards. WHO prequalification status is based on an assessment of the quality, safety, and efficacy of a medicine and enables the recipient to participate in UN procurement tenders. Herzuma has been commercially available in Europe since May 2018,…