Last week, Bio-Thera Solutions announced that a first patient has been dosed in its Phase III clinical trial study for ustekinumab biosimilar BAT2206. Stelara® (ustekinumab) is marketed by Johnson & Johnson Corp. for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, moderate to severe active Crohn’s disease…
On May 28, AbbVie brought a second action in the Northern District of Illinois for patent infringement against Alvotech hf. under the BPCIA in connection with Alvotech’s proposed biosimilar version of HUMIRA® (adalimumab). AbbVie’s first action was brought in the Northern District of Illinois on April 27, 2021. We previously…
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…
At the end of last month, Judge Connolly denied defendants Hospira and Pfizer’s motion to dismiss following a telephone conference with the parties. We previously reported back in February 2020 that Amgen sued Pfizer and its affiliate Hospira for patent infringement of U.S. Patent No. 8,273,707 (“’707 patent”) based on…
The National Comprehensive Cancer Network® (NCCN) Oncology Research Program (ORP) in collaboration with Pfizer announced this week a list of ten selected organizations and their research projects that have been chosen to receive funding to study the safe, effective, and efficient adoption of biosimilars in oncology: American Society of Clinical…
This month, a working group within the Pharmacy Directors Forum of the National Comprehensive Cancer Network (NCCN) has reviewed and highlighted “some of the potential challenges regarding adopting biosimilars into clinical practice,” making “several recommendations for the safe and efficient use of biosimilar medications in the clinical setting.” The group…
Enzene Biosciences Ltd., located in Pune, India, has announced that it has obtained marketing authorization from the Drug Controller General of India (DCGI) for its first biosimilar product in India. Enzene’s teriparatide biosimilar, indicated for the treatment of osteoporosis, will be marketed through Enzene’s holding company Alkem Laboratories, Ltd.
Biocon Biologics, a subsidiary of Biocon, announced today that it has signed an agreement with Clinton Health Access Initiative (CHAI) to develop advanced cancer therapies for patients in 25 countries in Africa and 5 countries in Asia as part of the Cancer Access Partnership (CAP). According to the announcement, Biocon Biologics aims…
The FDA has released a draft guidance for industry entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act.” According to the FDA, the draft guidance is “intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable products, as well as…