We previously reported FDA approval of Mylan and Biocon’s NDA for SEMGLEE (insulin glargine injection). Today, Mylan and Biocon announced the launch of SEMGLEE for the U.S. market. SEMGLEE is a biosimilar of LANTUS, Sanofi’s long-acting insulin glargine product. SEMGLEE will be available in vials and pre-filled pens. The lead…
Today, Cadila Pharmaceuticals announced the launch of its adalimumab biosimilar, Cadalimab™, in India. HUMIRA® (adalimumab) is approved to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis. Cadila’s press release noted that “[i]n an effort to strengthen their biosimilar product portfolio, Cadalimab™ is the fourth biosimilar launched in the last…
Yesterday, Lupin announced the German launch of its etanercept biosimilar, Nepexto, for the treatment of rheumatoid arthritis, as well as all other approved indications of the reference product Enbrel®. Lupin, in association with Mylan will release its etanercept product as an injectable in an easy-to-use pre-filled pen and a pre-filled…
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…