A preliminary review by FDA staff found that Amgen Inc.’s biosimilar of AbbVie Inc.’s Humira® showed potency and safety similar to the original product. Humira® (adalimumab) is the top-selling drug in the world and is used to treat autoimmune conditions including rheumatoid arthritis, Crohn’s disease, and ulcerative colitis. A panel…
Tuesday’s Federal Circuit opinion in Amgen v. Apotex is already being picked up and analyzed in other BPCIA litigation: in Amgen v. Hospira, Hospira has submitted the Federal Circuit’s opinion to the District Court for the District of Delaware (J. Andrews) in connection with its pending motion to dismiss Amgen’s…
As we posted yesterday, the Federal Circuit has issued its decision in Amgen v. Apotex, affirming the district court’s (S.D. Fla, J. Cohn) order preliminarily enjoining Apotex from launching its biosimilar version of Amgen’s Neulasta (pegfilgrastim) until it has received FDA licensure, given Amgen a post-licensure notice of commercial marketing, and then…
The Federal Circuit issued its decision in Amgen v. Apotex (re: Apotex’s Neulasta biosimilar) this morning. The Court affirmed the district court, holding that the commercial-marketing provision in 42 U.S.C. § 262(l)(8)(A) is mandatory and enforceable by injunction, even where the biosimilar applicant has triggered the patent dance by providing its…
AstraZeneca announced today that it has entered licensing agreements with LEO Pharma to develop and commercialize tralokinumab, a biologic that has completed a Phase IIb trial for atopic dermatitis, and brodalumab, which is under regulatory review to treat plaque psoriasis. Under the terms of the tralokinumab agreement, LEO Pharma will…
The United Kingdom’s referendum in favor of withdrawal from the European Union, colloquially known as “Brexit,” has already sent shockwaves through the business world, both within the UK, and abroad. The impact of Brexit on the pharmaceutical industry has yet to be determined, but some fear that Brexit will cause…
Back in March, 2016, the Senate added language to the FDA and NIH Workforce Authorities Modernization Act which would exempt biological products, including biosimilars, from provisions of the FDCA Act that require compliance with official compendia. This language includes compliance with the quality standards listed in the United States Pharmacopeia (USP)….
Last week, IMS Health released a report entitled “The Impact of Biosimilar Competition”. The report is an update of an earlier May 2015 report that noted that biosimilar uptake could save European and American health systems up to $110 billion by 2020. The current report discusses the expected changes to…
Hetero Drugs Ltd. has announced the launch of a biosimilar for Roche’s Avastin® (bevacizumab) in India. Hetero is marketing the drug under the brand name “CizumabTM” as a treatment for metastatic colorectal cancer. Hetero’s launch is the second release of an Avastin® biosimilar in India– earlier this month, Reliance Life Sciences launched its own…
Sandoz has announced plans to expand its biosimilars offerings within the next five years, including a total of 11 filings by the end of 2017, and 5 launches by 2020. Sandoz says that its next five launches will be biosimilars to Enbrel® (etanercept), Humira® (adalimumab), Neulasta ® (pegfilgrastim), Remicade® (infliximab)…