Further to our post last week on British Columbia’s policy requiring “switching” patients taking Humira, the Alberta government has also implemented a policy, effective May 1, 2021, of requiring that patients over the age of 18 taking Humira switch to one of five adalimumab biosimilars approved by Health Canada: Amgevita, Hadlima,…
Viatris announced during its Q1 2021 earnings call that its insulin glargine and insulin aspart products are both on track to be approved by the FDA as interchangeable by July 2021. These are proposed biosimilars of Sanofi’s LANTUS and Novo Nordisk’s NOVOLOG/NOVORAPID products, respectively. If approved, Viatris’s insulin products would…
On May 11, 2021, Alvotech USA and Alvotech hf (jointly, Alvotech) filed a complaint seeking declaratory judgement against AbbVie Inc. and AbbVie Biotechnology Ltd (jointly, AbbVie) in the Eastern District of Virginia. As readers of this blog may recall, in September 2020, Alvotech USA filed a BLA for AVT02, a…
On April 26, Representatives Paul D. Tonko (D-NY) and Bob Gibbs (R-OH) introduced the Star Rating for Biosimilars Act. The proposed legislation would direct the U.S. Department of Health & Human Services (HHS) to evaluate Medicare plans based on whether or not cost-saving biosimilars are available to enrollees and to evaluate…
On May 4, 2021, Amgen Canada announced the launch of their adalimumab biosimilar AMGEVITA (reference drug HUMIRA) for the treatment of 11 chronic inflammatory conditions. AMGEVITA is available as a prefilled syringe and a prefilled pen (SureClick® autoinjector) with a range of pack sizes to support dosing according to the…
On April 20, 2021, Korean company Huon Labs announced that it will develop a PROLIA biosimilar using PanGen Biotech’s cell culture and purification technology. PROLIA (denosumab), an Amgen product, is indicated to reduce the risk of facture in patients with osteoporosis with a particular concentration on patients that are postmenopausal…
The European Commission has approved mAbxience’s bevacizumab biosimilar, MB02, for marketing in Europe. As we previously reported, MB02, which will be known as Alymsys and Oyavas, is intended for the treatment of colon or rectal carcinoma, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian cancer, fallopian tube…
On May 3, 2021, Sandoz announced that it will begin enrolling patients in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study for its proposed biosimilar to Regeneron’s EYLEA (aflibercept) product. EYLEA is indicated for neovascular age-related macular degeneration (nAMD), diabetic macular oedema, macular oedema secondary to retinal vein…
This month, Biogen and Bio-Thera announced a commercialization and license agreement for their proposed tocilizumab biosimilar, currently in Phase 3 trials for the treatment of moderate to severe rheumatoid arthritis. BAT1806, a proposed biosimilar to Genentech’s ACTEMRA®, is an anti-interleukin-6 (IL-6) receptor monoclonal antibody indicated primarily for moderate to severe…
On April 23, 2021, Congressmen Schrader and Kinzinger introduced H.R. 2815, the Bolstering Innovative Option to Save Immediately on Medicines Act (“BIOSIM Act”). The bill provides for temporary increased reimbursement to hospitals and doctors for biosimilar drugs from the average sales price (ASP) of the drug plus 6% to the…