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…
Last week, the U.S. Patent and Trademark Office issued a notice pursuant to the Coronavirus Aid, Relief, and Economic Security (CARES) Act. Specifically, “[u]ntil further notice, examiner and examining attorney interviews, Patent Trial and Appeal Board (PTAB) and Trademark Trial and Appeal Board (TTAB) oral hearings, and other similar in-person…
Mabion We previously reported last month that applications for initial marketing authorization for two rituximab biosimilars were withdrawn from the European Medicines Agency (EMA), according to the Committee for Medicinal Products for Human Use (CHMP). In particular, the EMA reported that these applications were withdrawn after the agency had evaluated…
COVID-19 Delays Proposed Combination of Mylan and Upjohn Mylan N.V. and Pfizer Inc. have announced that unprecedented circumstances surrounding the COVID-19 pandemic will delay the proposed integration of Mylan and Upjohn, a division of Pfizer. As we previously reported, Mylan and Upjohn, Pfizer’s off-patent branded and generic business, will combine…
On March 30, in the Genentech v. Amgen trastuzumab and bevacizumab biosimilar patent litigations, Delaware District Judge Connolly ordered the appointment of a special master to handle the parties’ requests to seal various court filings. Judge Connolly stated that “[r]ecent sealed and redacted filings in these related cases make clear that…