As we previously reported, the district court in Janssen v. Celltrion (in which U.S. Patent Nos. 6,284,471 and 7,598,083 are at issue) began hearing oral argument on August 16 on Celltrion’s motion for summary judgment that all claims of the ’471 patent-in-suit are invalid for obviousness-type double patenting, as well…
As we previously reported, on June 17, Janssen filed two complaints alleging infringement of claims in U.S. Patent No. 7,598,083, one against Celltrion and Hospira, and one against HyClone Laboratories, Celltrion’s supplier of cell culture media. On August 5th, HyClone filed a motion for injunctive relief to dismiss and to…
Epirus Biopharmaceuticals, a biosimilar startup, has filed for Chapter 7 bankruptcy. The Boston-based startup had lost approximately 82% of its value by June of 2016, after an announcement that it would cease working on a biosimilar of Remicade (infliximab) to focus on Soliris (eculizumab) and Actemra (tocilizumab), a cut in…
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)…
In the ongoing litigation over infliximab biosimilars, Janssen has filed two new complaints alleging infringement of claims in U.S. Patent No. 7,598,083: one against Celltrion and Hospira, and a second against HyClone Laboratories, Celltrion’s Utah-based supplier of cell culture media. These complaints follow Judge Wolf’s recent order in Janssen’s original…
According to the Korea Pharmaceutical Manufacturers Association, the biosimilars market in South Korea will grow to 150 billion won (~$130 million) by 2019, nearly doubling in size from its 2013 value. Six biosimilars have been approved in South Korea since 2012, and dozens of other biosimilars are currently in the development…
At the Annual European Congress on Rheumatology (EULAR 2016), held last week in London, Samsung Bioepis presented new clinical data on its etanercept, adalimumab, and infliximab biosimilars. According to a press release from Biogen, a partner in the Samsung Bioepis joint venture with Samsung BioLogics, Phase III studies for those anti-TNF-α biosimilars have demonstrated that…
We previously reported that the FDA approved Celltrion’s Inflectra®, a biosimilar to Janssen’s Remicade® (infliximab) on April 5, 2016. A year prior to the approval, Janssen filed a motion for summary judgment and preliminary and permanent injunction based on the contention that 42 U.S.C. § 262(l)(8)(A) prohibits Celltrion from commercially marketing its biosimilar…
On May 30, the European Commission granted marketing authorization for FLIXABI,® an infliximab biosimilar developed by Samsung Bioepis, the joint venture between Biogen and Samsung Biologics. See here for press coverage.
On May 16, 2016, Sorrento Therapeutics announced successful results from a Phase 2 and 3 clinical study for a biosimilar to Xolair. Xolair (omalizumab) is marketed by Genentech and Novartis to treat allergic asthma and chronic idiopathic urticaria (a chronic skin condition). Sorrento’s biosimilar product, dubbed STI-004, proved to be…