On this blog, we have been following two Celltrion biosimilars: CT-P10 (rituximab) and CT-P13 (infliximab, the subject of the Janssen v. Celltrion litigation). According to a Celltrion press release, new data released today at the 2016 American College of Rheumatology (ACR) Annual Meeting show that the efficacy and safety profile…
This morning, Eagle Pharmaceuticals announced that it has entered into an agreement to acquire Arsia Therapeutics. According to Arsia’s website, Arsia’s technology enables the production of high-concentration, low-viscosity biologics that can be delivered to patients by subcutaneous injection, autoinjector pen, or patch pump. Eagle’s press release states that the acquisition…
The Committee for Medicinal Products for Human Use, (“CHMP”), the committee at the European Medicines Agency (“EMA”) that is responsible for preparing opinions on questions concerning medicines for human use met earlier this week and recommended approval of nine medicines to the EMA. Of the nine medicines recommended for approval,…
If you plan to attend next week’s 2016 BIO Intellectual Property Counsels Committee Fall Conference, please keep an eye out for members of the Big Molecule Watch team. Big Molecule Watch editor Cynthia Hardman will moderate the conversation during the day-two luncheon fireside chat, “Standing on the Front Lines: Trials…
On November 8, 2016, Amgen submitted a brief in opposition to Apotex’s petition for certiorari challenging the Federal Circuit’s application of its holding in Amgen v. Sandoz that subsection (l)(8)(A) of the BPCIA allows an aBLA applicant to provide notice of commercial marketing only after it receives approval, as well…
While Donald Trump’s victory has made world headlines, what may be less well known to our readers is that the election also gave Trump’s Republican Party majority control of both the House and the Senate. For the first time in many years, Republicans will control both the White House and…
On November 2, the Biosimilars Forum released the results of a survey in an article titled “Awareness, Knowledge, and Perceptions of Biosimilars Among Specialty Physicians,” published in Advances in Therapy. According to the abstract of the article, the survey was conducted from November, 2015, through January, 2016, and sought to assess…
The election last night of Donald Trump as the next President of the United States may have far-reaching consequences on numerous legal and policy issues, including immigration, international trade, and health care. Although we are not aware of President-elect Trump ever directly mentioning biosimilars on the campaign trail, it is…
On November 8, 2016, Mylan and Biocon submitted an aBLA for MYL-1401O, a proposed biosimilar to Genentech’s Herceptin® (trastuzumab). According to the Mylan press release, this submission is Mylan’s first for a biosimilar in the United States, and may lead to the first approved trastuzumab biosimilar in the United States. Mylan…
The PTAB has denied institution of inter partes review of Abbvie’s U.S. Patent No. 9,114,166, finding that Petitioner Coherus had not established a reasonable likelihood that it would prevail in showing the unpatentability of the challenged claims. The ‘166 patent is drawn to pharmaceutical formulations comprising an anti-TNFα antibody, and…