On July 20, 2018, Pfizer issued a press release reporting that the U.S. FDA has approved Nivestym™ (filgrastim-aafi), Pfizer’s proposed biosimilar of Neupogen®, for all eligible indications of the reference product. Pfizer states that “NIVESTYM is expected to be available in the U.S. at a significant discount to the current…
This morning, the Federal Circuit issued its much anticipated decision in St. Regis Mohawk Tribe v. Mylan Pharmaceuticals. A panel of the court, consisting of Judges Dyk, Moore, and Reyna, held that “tribunal sovereign immunity cannot be asserted in IPRs.” Relying on the Supreme Court’s decisions in Oil States and SAS Institute,…
Today, the U.S. FDA released its Biosimilar Action Plan (BAP), which outlines the Administration’s proposed next steps to help reduce the costs of healthcare by expediting the development of robust biosimilar competition and market penetration, while encouraging innovation and maintaining incentives for investing in future products. In remarks delivered at…
Today, Amgen filed against Mylan concerning its Fulphila® (pegfilgrastim-jmdb) biosimilar of Neulasta®, and against Adello concerning its proposed filgrastim biosimilar. According to the complaint, the parties engaged in the patent dance, during which the parties negotiated and ultimately agreed that, of the seven patents that Amgen identified on its list…
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…