As we previously reported, earlier this year the Federal Circuit affirmed a district court’s finding that Sandoz’s ZARXIO filgrastim biosimilar and proposed pegfilgrastim biosimilar do not infringe Amgen’s patents. The patents-at-issue were Amgen’s U.S. Patent Nos. 8,940,878 (“the ’878 patent”) and 6,162,427 (“the ’427 patent”). The ’872 patent is directed towards methods of purifying
On February 21, 2019, Sandoz Inc. (“Sandoz”) filed suit against Amgen Inc. and Amgen Manufacturing Limited (collectively “Amgen”) seeking declaratory judgment of non-infringement and invalidity of Amgen’s U.S. Patent No. 9,643,997 (“the ʼ997 patent”). The ʼ997 patent is directed to methods of purifying a protein expressed in a non-native limited solubility form in a non-mammalian
RFEM’s Biosimilars IPR Dashboard provides current information on IPR proceedings related to proposed biosimilar products.
Earlier this month, Amgen initiated suit against Apotex in the Middle District of Florida, alleging infringement of U.S. Patent No. 9,856,287 (“the ’287 patent”). This is the third complaint that Amgen has brought against Apotex under the Biologics Price Competition and Innovation Act (the “BPCIA”), based on Apotex’s abbreviated biologic license applications (“aBLAs”) for biosimilars
Earlier this month, the U.S. FDA announced approval of Mylan’s Fulphila biosimilar to Neulasta® (pegfilgrastim). Neulasta® was developed by Amgen and first approved in the U.S. and Europe in 2002. Following the approval announced on June 4, 2018, Fulphila, which was co-developed with Biocon, becomes the first biosimilar to pegfilgrastim approved in the U.S.
The
Last week, on April 18, 2018, Judge Stark in the District of Delaware entered the Final Judgment and Order dismissing the patent infringement case brought by Amgen Inc. and Amgen Manufacturing, Limited (collectively “Amgen”) against Coherus Biosciences, Inc. (“Coherus”). Judge Stark previously issued a Memorandum Order on March 26, 2018, adopting Magistrate Judge Burke’s Report
Biologic drugs are large molecules, such as therapeutic proteins, DNA vaccines, monoclonal antibodies, and fusion proteins, that are typically derived from living cells and used in the treatment, diagnosis, or prevention of disease. Most biologics are produced by genetically engineering living cells to express the therapeutic proteins rather than through traditional chemical synthesis. As proteins
Sandoz announced that its biosimilar application for Neulasta® (pegfilgrastim) has been accepted for regulatory review by the European Medicines Agency (“EMA”). According to Sandoz, “[t]he comprehensive data package, submitted as part of the Marketing Authorization Application, includes analytical, preclinical and clinical data and strongly demonstrates that the biosimilar pegfilgrastim matches the reference medicine in terms
Biologic drugs are quickly reshaping the pharmaceutical landscape as they dominate the drug market in annual sales revenue. Abbvie’s Humira® (adalimumab) rocketed to the best-selling drug in the world with sales generating over $16 billion USD in 2016. The top biologic drugs are all driving revenues well beyond the $1 billion sales revenue demarcation that
Introduction and Background
The Apotex filgrastim/pegfilgrastim biosimilar litigation was the first biosimilar litigation where the parties participated in the patent dance. As a result, important issues regarding the interpretation of the Biologics Price Competition and Innovation Act (the “BPCIA”) were raised, including whether a biosimilar applicant (“(k) applicant”) must give 180-days’ notice to the reference