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previously reported last month that applications for initial marketing authorization for two rituximab biosimilars were withdrawn from the European Medicines Agency (EMA), according to the Committee for Medicinal Products for Human Use (CHMP). In particular, the EMA reported that these applications were withdrawn after the agency had evaluated…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…
On March 30, 2020, Russian pharmaceutical company, Biocad, announced that it and its partner, ICM d.o.o., recently obtained European registration certification in Bosnia and Herzegovina for two cancer treatment biosimilars: Acellbia (rituximab), a biosimilar of Roche’s MabThera®, and Herticad (trastuzumab), a biosimilar of Roche’s Herceptin®. According to Biocad, the registration…
We previously covered the Patent Trial and Appeal Board’s (the “Board”) institution of inter partes reviews filed by Mylan challenging the validity of various Sanofi patents relating to devices for administering insulin glargine: IPR2018-01675, IPR2018-01676 (Patent 8,603,044 B2); IPR2018-01678, IPR2018-01679, IPR2019-00122 (Patent 8,992,486); IPR2018-01680, IPR2018-01682 (Patent 9,526,844 B2); and IPR2018-01684 (Patent…
The European Medical Agency’s Committee for Medicinal Products for Human Use (CHMP) recently reported biosimilar updates from its March 2020 meeting. At the meeting, Mylan and Lupin’s NEPEXTO (etanercept) received a positive opinion for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing…
This week, the U.S. Court of Appeals for the Federal Circuit issued two rulings in biosimilar-related appeals from final written decisions by the Patent Trial and Appeal Board (PTAB) in inter partes review (IPR) proceedings. Genentech v. Iancu (USPTO), Nos. 19-1263, -1265, -1267, -1270 On March 26, 2020, the Federal…