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…
Following approval by the European Commission in July, last week Accord Healthcare announced the launch of Zercepac® a biosimilar to Herceptin® in the United Kingdom. According to the press release, Zercepac® is indicated for the treatment of certain patients with HER2-positive early breast cancer, HER2-positive metastatic breast cancer, and previously untreated…
On September 19, 2020, Lotus Pharmaceutical Co., Ltd. (“Lotus”) and Chong Kun Dang Pharmaceutical Corp. (“CKD”) announced that they have entered into a commercialization agreement in connection with CKD’s biosimilar darbepoetin alfa, a second-generation epoetin indicated for the treatment of anemia associated with chronic renal failure. According to Lotus’ press…
On September 9, 2020, Genentech, Inc. and JHL Biotech, Inc. filed a stipulation for entry of a proposed consent judgment and permanent injunction as to JHL Biotech, Inc. That proposed consent judgment and permanent injunction is the result of the parties’ June 18, 2020 settlement agreement, in which JHL represented…
On September 15, 2020, Merck Canada Inc., an affiliate of Merck & Co., Inc., announced that Health Canada approved BRENZYS® (etanercept) for the following additional indications: Adult patients with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy; Pediatric patients ages 4 to 17…
In late August, MIT announced that a group of MIT researchers led by Kripa Varanasi published a paper describing a low-cost technology for administering biological drug formulations otherwise too viscous to be injected using conventional medical syringes. The system utilizes a syringe having an inner barrel containing viscous drug fluid and an outer barrel…