Below are some recent developments in the biosimilar industry from around the globe: On January 14, 2020, Alvotech announced that it entered into a partnership with Canada-based JAMP Pharma for the supply and commercialization of five biosimilar candidates in the Canadian market. According to the announcement, Alvotech will be responsible…
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%…
Last month, a three-judge panel of the Federal Circuit affirmed a Delaware district court’s judgment of infringement against Hospira and $70 million damages award to Amgen in the parties’ BPCIA litigation regarding Hospira’s RETACRIT (epoetin alfa-epbx), a biosimilar of EPOGEN. This past week, Hospira filed a petition for rehearing en…
Last week, Almirall signed an agreement with WuXi Biologics to collaborate on multiple bispecific antibodies targeting dermatology conditions, including atopic dermatitis. Almirall’s press release indicated that, “[u]nder the terms of the agreement, Almirall has access to WuXi Biologics’ proprietary antibody platforms including WuXiBody™ to discover multiple novel bispecific antibodies.” This…
The past few weeks have seen the following biosimilar developments in China: On December 16, 2019, Qilu Pharmaceutical received approval in China for ANKADA, a biosimilar to AVASTIN (bevacizumab). ANKADA has been approved to treat advanced, metastatic or recurrent non-small-cell lung cancer and metastatic colorectal cancer. On December 30, 2019,…
Below we provide an update on some recent developments from this and recent weeks in biosimilar-related cases on appeal before the Federal Circuit. Genentech v. Hospira & U.S., Fed. Cir. Case No. 18-1933 – protein purification method IPR appeal Today, the Federal Circuit issued a 2-1 opinion affirming a 2018…
This week, in the Immunex v. Samsung Bioepis BPCIA litigation regarding ETICOVO (etanercept-ykro), Samsung Bioepis’s biosimilar of ENBREL, the New Jersey district court entered a Consent Injunction Order that prohibits Samsung Bioepis from using, importing, offering to sell, or selling any etanercept product in the United States, except as allowed…
Following the string of biosimilar agreements announced in early November, a number of additional transactions were announced in early December, bringing 2019 to a roaring close with global biosimilars deals. On December 1, 2019, Luye Pharma Group announced that it acquired Shandong Boan Biological Technology Co. Ltd. (Boan), strengthening its…
Here are our picks of some legal developments to keep an eye out for in the new year: Federal Circuit Decisions on Bevacizumab and Trastuzumab Preliminary Injunctions: Appeals are pending on the District of Delaware’s denial of preliminary injunctions in cases brought by Genentech against Amgen regarding Amgen’s bevacizumab and…
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),…