This week, three development programs announced updates to their ranibizumab biosimilars. Ranibizumab is the active ingredient in Genentech’s LUCENTIS, which is indicated for retinal vascular disorders, including neovascular (wet) age-related macular degeneration (AMD). On June 25, 2021, Samsung Bioepis Co., Ltd. (“Samsung Bioepis”) and Biogen Inc. (“Biogen”) announced that the…
The U.S. health insurance provider Cigna has provided a financial incentive to patients who switch to an infliximab biosimilar, through a one-time $500 debit card for health care services and products called the “Shared Savings Program.” Cigna has promoted this program as a way to promote biosimilar use and reduce…
Amneal Pharmaceuticals, Inc., a fully integrated pharmaceutical company headquartered in Bridgewater, NJ, announced last week that the U.S. FDA has accepted its aBLA seeking approval of a biosimilar of Avastin® (bevacizumab). This biosimilar was developed in collaboration with Spain-based biopharmaceutical company mAbxience, which had obtained approval earlier this year to…
In the long-awaited decision in United States v. Arthrex, Inc., the U.S. Supreme Court confirmed that the Patent Trial and Appeal Board is unconstitutionally structured, but held that the correct remedy is more limited than the one the U.S. Court of Appeals for the Federal Circuit had granted. Instead of…
On June 16, 2021, the District Court for the District of Delaware issued a claim construction order construing a key term in the ongoing patent dispute between Amgen and Hospira over Hospira’s proposed biosimilar of Amgen’s Neulasta® (pegfilgrastim). In the Order, the Court construed the term “between about 0.1 M…
Global pharmaceutical company Lupin Limited recently announced that the U.S. FDA has accepted its aBLA for a proposed pegfilgrastim biosimilar (reference product Neulasta®). Lupin reported that the aBLA submission was supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies. Company CEO Vinita Gupta commented, “FDA’s acceptance of our…
As we previously reported, earlier this year Merck announced that it would be spinning off its women’s health, biosimilars, and established brands businesses into a standalone company. This month, Merck completed the spinoff, creating Organon. Organon’s portfolio contains about 60 treatments and products, and mainly focuses on ex-US markets. Organon…
On Thursday Theramex announced that it has entered into an agreement to register and commercialize denosumab, a biosimilar of Enzene Bioscience’s Prolia®, which treats osteoporosis by decreasing bone absorption. The agreement licenses Theramex to market the drug for use in Europe and Australia. Enzene will exclusively supply the finished product…
Celltrion Healthcare announced last week that it received positive results from the Phase III trial of its high-concentration, low-volume, citrate-free adalimumab biosimilar, CT-P17 or Yuflyma™, in patients with active rheumatoid arthritis (RA). According to the press release, “[r]esults demonstrated comparable efficacy in terms of ACR20/50/70 response rates, both in patients…
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…