Following the oral argument three days ago, the U.S. Court of Appeals for the Federal Circuit today affirmed the lower court’s denial of Genentech’s motion for a preliminary injunction to enjoin sales of Amgen’s KANJINTI (trastuzumab-anns) biosimilar product. As we previously reported, Amgen launched KANJINTI in the United States in…
On January 15, 2020, the Romanian Competition Council fined fined Roche Romania SRL €12.9 million ($14.2 million) following two investigations into what the Competition Counsel found to be Roche’s anti-competitive practices related to its cancer drugs. In the first investigation, the Competition Council found that between 2017 and 2019 Roche…
Today, Pfizer announced that it has launched or is launching the following three biosimilars in the United States at the following prices: ZIRABEV (bevacizumab-bvzr), which was introduced to the U.S. market on December 31, 2019, at a Wholesale Acquisition Cost (WAC) of $61.34 per 10 mg, which represents a 23%…
As we start the new year, we look back at the top U.S. biosimilar market developments of 2019. Here are some of our highlights, in no particular order: 1) Launch of First and Second U.S. Trastuzumab Biosimilars: In July 2019, Amgen and Allergan announced the U.S. launch of KANJINTI (trastuzumab-anns),…
Below are some recent highlights of biosimilar news: On August 20th, two companies announced that they had launched competing biosimilars of Eli Lilly’s FORSTEO (teriparatide) in Europe. First, Gedeon Richter announced that it launched TERROSA in Europe after it received approval from the European Commission. According to the announcement, the…
Last week, several briefs were filed in Federal Circuit appeals relating to trastuzumab biosimilars: Trastuzumab IPR Appeals On September 3, 2019, the USPTO submitted responsive appellate briefs in Federal Circuit appeals from IPR final written decisions regarding two patents related to methods of treating HER2+ cancer with trastuzumab (Cases Nos….
On September 5, JHL Biotech announced that it has reached a settlement agreement with Genentech to resolve the parties’ lawsuit regarding JHL’s alleged misappropriation of trade secrets relating to Genentech’s Rituxan® (rituximab), Herceptin® (trastuzumab), Avastin® (bevacizumab), and Pulmozyme® (dornase alfa) products. As we previously reported, in October 2018, Genentech filed…
In recent weeks, several drug makers announced collaborations for the development, manufacture, and/or commercialization of a variety of biosimilars or follow-on biologics. Below are some highlights: On September 3, 2019, Polpharma Biologics and Sandoz announced that they have entered into a global commercialization agreement in connection with Polpharma’s proposed biosimilar…
United Healthcare and OneOncology have added Amgen’s MVASI (bevacizumab-awwb) and KANJINTI (trastuzumab-anns), biosimilars to AVASTIN and HERCEPTIN respectively, as preferred products, according to literature released by those providers. United Healthcare released a bulletin indicating that, as of October 1, 2019, United Healthcare will update its preferred product language to reflect…
Below are highlights of biosimilar development news from the past couple of weeks: On August 5, Revance Therapeutics indicated on its quarterly earnings call that it has continued to have discussions with its collaborator Mylan about their proposed biosimilar of BOTOX (onabotulinumtoxinA) since their initial advisory meeting with the FDA…