Yesterday, Johnson & Johnson (J&J) released its Q2 2018 financials and held an earnings call with analysts. J&J reported Remicade® sales in Q2 2018 of $918 million in the U.S. and $1.320 billion worldwide, which is a 13.7% decline over the sales J&J reported for the same quarter last year…
This morning AbbVie announced that it has entered into patent license agreements with Mylan over its proposed biosimilar of Humira® (adalimumab). AbbVie states that it has agreed to “grant Mylan a non-exclusive license on specified dates to AbbVie’s intellectual property relating to HUMIRA in the United States and in various…
Below is our second quarter update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our previous quarterly updates (Q3 2016, Q4 2016, Q1 2017, Q2 2017, Q3 2017, Q4 2017, Q1 2018). Please also refer to our BPCIA Patent Litigation and Federal…
Today, XBrane Biopharma and STADA Arzneimittel announced that they have entered into a co-development agreement for Xlucane, a proposed biosimilar of Lucentis® (ranibizumab), in which the companies will equally contribute and share in profits from commercialization in a 50/50 split. According to the press release, Xbrane will be responsible for…
Earlier this week, JHL Biotech announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided it with positive scientific advice regarding JHL1101, its proposed biosimilar of MabThera® (rituximab). According to the press release, “the EMA confirmed that it agrees with JHL’s…
In a series of tweets on July 8, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., announced that the FDA “will soon unveil a comprehensive Biosimilars Action Plan (BAP) that will include policies and actions to improve the efficiency of FDA’s review of biosimilar marketing applications and increase…
Goodwin attorneys and Big Molecule Watch editors Keith Zullow, Michael Cottler, and Joshua Whitehill were recently published on Bloomberg Law. Disputes often arise regarding what is required of a biosimilar applicant to comply with Subsection (l)(2)(A) of the BPCIA, a provision that kicks off the patent dance. Although this issue…
There are presently seven biosimilar-related appeals pending before the Federal Circuit. Two of those appeals, Amgen v. Sandoz (Case No. 18-1551) and Amgen v. Coherus (Case No. 18-1993), are from district court judgments in favor of the biosimilar applicants. The other five appeals are from final written decisions of the…
Last week, Genentech Inc. filed a complaint against Eli Lilly and Company (Lilly) in the United States District Court for the Southern District of California alleging infringement of U.S. Patent No. 10,011,654 (’654 patent) based on Eli Lilly’s commercial manufacture, use, sale, offer for sale and/or importation of Taltz® (ixekizumab) in…
Last week Biocon announced that it has received EU GMP certification for its biosimilars facility in Bangalore, after an inspection by European agencies this past March. Biocon’s Bangalore biosimilar facilities were also inspected earlier this year by the FDA, and last month Biocon announced the FDA issued an Establishment Inspection Report stating “that the inspection stands…