We previously reported that on September 12, 2017, the FDA accepted for review Sandoz’s aBLA for a proposed biosimilar of Rituxan® (rituximab), which is indicated for the treatment of certain blood cancers and immunological diseases. Yesterday, Genentech filed a complaint in the District of New Jersey based on Sandoz’s proposed rituximab biosimilar, Rixathon/GP2013. Genentech…
Below are recent updates in biosimilar-related IPR proceedings: GENERAL BIOLOGICS PATENTS On December 1, 2017, the Board granted institution of four IPRs on Celltrion’s petitions (IPR2017-01373 and IPR2017-01374) and Pfizer’s petitions (IPR2017-01488 and IPR2017-01489 [decisions under seal]) challenging Genentech’s Carter patent, U.S. Patent No. 6,407,213, directed to humanized antibodies. This same patent…
Here are some updates since our last IPR update: HUMIRA On November 6, 2017, Sandoz filed an IPR Petition challenging AbbVie’s U.S. Patent No. 9,187,559 (IPR2018-00156). The ‘559 patent is directed to a method for treating idiopathic inflammatory bowel disease. RITUXAN On November 6, 2017, the Board denied institution of an IPR on Pfizer’s…
On November 14, 2017, Sandoz announced data from four clinical trials comparing its proposed adalimumab and rituximab biosimilars to their reference drugs, Humira® and Rituxan®. We previously reported that the Sandoz adalimumab biosimilar is currently under EMA review. As we reported here, the Sandoz rituximab biosimilar has been approved by the European Commission…
Below are some highlights from third quarter earnings reports recently released by biologics and biosimilar companies. Johnson & Johnson reported that Remicade (infliximab) sales declined more than 1% in the U.S. and more than 8% worldwide year-over-year. During its earnings call, company executives explained that two-thirds of the decline in sales in Europe…
The PTAB remains a busy venue for biologics patents. Here are some IPR updates from the weeks since our last IPR update: HERCEPTIN On October 4, the Board instituted IPR on four petitions that Celltrion had filed on Genentech patents related to Herceptin® (trastuzumab): IPR2017-01121 (challenging U.S. Patent 7,846,441); IPR2017-01122 (challenging U.S. Patent No….
According to press releases this week, the FDA has recently accepted two new Abbreviated Biologics License Applications (aBLA) for review. First, Adello Biologics yesterday announced that the FDA has accepted its aBLA for its proposed biosimilar of Neupogen® (filgrastim), which is indicated for, among other things, the treatment of neutropenia-related…
Novartis recently released its Q2 2017 financials, which included updates on various biosimilar products in its subsidiary Sandoz’s pipeline. Pegfligrastim As we previously reported last July, the FDA last year issued a complete response letter (CRL) rejecting Sandoz’s aBLA for LA-EP2006, a proposed biosimilar of Neulasta® (pegfilgrastim). Sandoz subsequently indicated…
On July 4, 2017, BIOCAD, a Russia biotechnology company, announced that in August 2017, it expects to receive permanent market authorization in India for Acellbia, its rituximab biosimilar. BIOCAD reports that its first shipment of Acellbia to India is scheduled for September 2017. As we previously reported, BIOCAD has also…
Celltrion and Teva announced today that the FDA has accepted for standard review their BLA for CT-P10 and that regulatory action is expected in the first quarter of 2018. CT-P10 is a proposed biosimilar to Rituxan® (rituximab). Rituxan® (marketed as MabThera® in the EU) is approved for the treatment of non-Hodgkin’s…