On Monday, Spectrum Pharmaceuticals announced that the FDA was reportedly unable to conduct its required inspections of Spectrum’s Hanmi Bioplant due to travel restrictions related to the COVID-19 pandemic, and that as a result, the FDA was deferring action on the company’s Biologics License Application for ROLONTIS (eflapegrastim) until the…
On October 20, 2020, NeuClone announced that it successfully completed its Phase I clinical trial of NeuLara, its proposed biosimilar of Stelara (ustekinumab). According to Neuclone, the Phase I clinical trial demonstrated similar clinical pharmacokinetics, and safety, immunogenicity and tolerability profiles of NeuLara compared to US- and EU-sourced Stelara. NeuLara…
As previously reported, in February 2019, the Patent Trial and Appeal Board issued final written decisions in two IPR proceedings initiated by Sanofi challenging the U.S. Patent No. 8,679,487 (the ’487 patent) owned by Immunex. In IPR2017-01884, the Board held that the challenged claims of the ‘487 patent were unpatentable…
Last week, the EMA issued a positive opinion for Orphan Drug Designation (“ODD”) to Prestige BioPharma’s PBP1510, a first-in-class anti-PAUF monoclonal antibody. PAUF is found in a majority of pancreatic cancers and plays an important role in disease progression; PBP1510 received ODD for the treatment of pancreatic cancer, for which…
In an effort to enhance development of medical products for orphan diseases (or rare diseases), the U.S. Food and Drug Administration announced on October 8, 2020 that it awarded six new grants for clinical trial research, including a grant for ustekinumab (STELARA®) for the prevention of graft versus host disease. …
This week, IQVIA released an independent report on its research into the current state of the biologics market in the United States. IQVIA, formerly Quintiles and IMS Health, Inc., is a contract research organization serving the combined industries of health information technology and clinical research. In an overview of the…
Today, Samsung Bioepis and Biogen announced that the EMA has accepted for review its Marketing Authorization for their proposed biosimilar product referencing eye disease product Lucentis (ranibizumab). Ranibizumab is an anti-VEGF (vascular endothelial growth factor) for retinal vascular disorders, which are a leading cause of blindness. Last year, we reported…
Yesterday, Medicure, Inc. announced that its wholly-owned subsidiary, Medicure International Inc., has entered into a license, manufacture and supply agreement with Reliance Life Sciences Private Limited for a cardiovascular biosimilar. The identity of the biosimilar was not disclosed. Medicure will be responsible for the regulatory approval process for the biosimilar.
On October 2, 2020, the United States Patent and Trademark Office (USPTO) adjusted its patent fees for the first time in almost three years, including an approximately 5% increase to most fees impacted by the rule. For IPRs, the minimum fees increased from $30,500 to $41,500, including the fee for a…
Alvotech and DKSH recently announced an expansion of their strategic partnership to commercialize six new biosimilar candidates for the Asian markets. The press release does not name the biosimilar candidates, but states that they “address[] multiple therapeutic areas.” The companies previously entered into an exclusive license partnership for Alvotech’s adalimumab…