On March 22, British Columbia’s Ministry of Health announced that three new enoxaparin biosimilars, Valero Pharmaceuticals’ REDESCA, Juno Pharmaceuticals’ , and Sandoz’s INCLUNOX, would be covered by PharmaCare, the province’s public health plan. Enoxaparin is a blood thinner that is used for the prevention and treatment of blood clot disorders. …
On February 18, 2022, in the first and second wave suits filed by AbbVie Inc. et al. (AbbVie) against Alvotech hf. (Alvotech) regarding an adalimumab biosimilar, AbbVie filed a motion to strike Alvotech’s Final Invalidity and Unenforceability Contentions and a memorandum in support thereof. AbbVie moved the Court to strike…
Eris Lifesciences (“Eris”) announced its joint venture with Mumbai-based MJ Biopharm Pvt Ltd. (“MJ”), Eris MJ Biopharm Ltd., focused on the marketing and distribution of insulins (including aspart, glargine and lispro), GLP1 agonists, and potentially other biopharma products in India. Under the agreement, MJ will be responsible for the development,…
In their respective third quarter financial results, Amgen and Pfizer both announced plans to seek interchangeable status for select biosimilars. Amgen announced that patients are currently being enrolled in Phase 3 studies to support interchangeability designation in the U.S. for biosimilars of AMJEVITA (adalimumab) and ABP 654 (ustekinumab). Pfizer also…
A study recently published in Cancer Communications reported that LY01008 or BOYOUNUO, a bevacizumab biosimilar developed by Shandong Boan Biotechnology Co., Ltd. (“Shandong Boan”), a subsidiary of Luye Pharma Group Ltd. (“Luye Pharma”), demonstrated comparable safety, efficacy, immunogenicity, and pharmacokinetic profiles to the reference product AVASTIN in patients with advanced…
On July 6, 2021 Alvotech announced the start of a comparative, confirmatory efficacy and safety clinical study comparing AVT04, Alvotech’s proposed ustekinumab biosimilar, to the reference product STELARA, in patients with moderate-to-severe chronic plaque psoriasis. The announcement states that the study is being conducted in five countries in Central and…
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…
On March 29, Samsung Bioepis announced the launch of its adalimumab biosimilar HadlimaTM, referencing AbbVie’s HumiraTM, in Australia in partnership with Merck & Co. HadlimaTM is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult and paediatric Crohn’s disease, ulcerative colitis, hidradenitis suppurativa and…
As we previously reported in August 2019, the District Court for the District of Delaware issued an opinion granting Sanofi’s motion for judgment as a matter of law that the asserted claims of two of Amgen’s patents, U.S. Patent Nos. 8,829,165 (the “’165 patent”) and 8,859,741 (the “’741 patent”), covering…