Swedish biotechnology company Xbrane Biopharma reports that, despite the difficulties posed by the Covid-19 pandemic, it will continue to recruit patients for the ongoing Phase III trial of its Xlucane® (ranibizumab) biosimilar product, and that it is still on track towards regulatory approval ahead of Lucentis® patent expiration in the…
On Thursday, April 23rd, Goodwin will be hosting a webinar, Navigating Hatch-Waxman and Biologic Litigation Amid the Coronavirus Pandemic. Join Goodwin experts Elaine Blais, Srikanth Reddy and Daryl Wiesen as they discuss how courts and litigants have begun to address litigation in the evolving current environment and the issues that…
We previously reported on the bevacizumab preliminary injunction appeal in Genentech v. Immunex Rhode Island Corp., Fed. Cir. Case No. 19-2155. The notice of oral argument was posted today and is scheduled for June 3, 2020.
The Supreme Court yesterday narrowed the scope of judicial review of proceedings before the Patent Trial and Appeal Board (PTAB) in Thryv, Inc. v. Click-to-Call Technologies, LP. Thryv had petitioned the PTAB to institute an IPR of Click-to-Call‘s patent. Thryv’s predecessor had been sued on that patent more than one…
On Wednesday, Samsung Bioepis and Merck announced the U.S. launch of Ontruzant® (trastuzumab-dttb), a biosimilar to Herceptin® (trastuzumab). Ontruzant® is indicated for the treatment of HER2-overexpressing breast cancer, and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, and is available in both 150 mg single-dose vials and 420 mg multiple-dose vials. …
Lannett has announced that it will meet with the FDA on June 9, 2020, to “plan next steps for the clinical advancement of” its insulin glargine biosimilar product. According to the press release, “[i]nsulin glargine is a long-acting insulin used to treat adults with Type 2 diabetes, as well as…
We have previously reported on the Amgen v. Sanofi Praulent® litigation, which has been ongoing since late 2014. After the parties stipulated to infringement, a jury in the District of Delaware found in favor of Amgen and the validity of its patents over its biologic drug Repatha® (evolucumab) in March…
We have been covering Pfizer’s antitrust suit against Johnson & Johnson (J&J), the manufacturer of Remicade® (infliximab). As we previously reported, Pfizer filed an antitrust lawsuit in September 2017 against J&J in the U.S. District Court for the Eastern District of Pennsylvania alleging that J&J has engaged in an anticompetitive scheme…
Shanghai Henlius biosimilar antibody developments On March 9, 2020, Shanghai Henlius Biotech, Inc. announced that its investigational new drug application has been accepted by China’s National Medical Products Administration (NMPA) for HLX14, a biosimililar to Amgen’s PROLIA (denosumab). According to the press release, HLX14 is indicated for the treatment of…
We are pleased to present the first in a series of webinars relating to Goodwin’s Guide to Biosimilars Litigation and Regulation in the U.S. which provides expert guidance and practical know-how for lawyers working in this growing area of the law. The first webinar, So You Want To Make A…