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 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…
As biosimilars begin to gain traction in the U.S. pharmaceutical market, the distinct labeling requirements applicable to them are likely to affect product liability litigation in this area, raising implications that are potentially distinct from those applicable to biologics and to small-molecule, generic drugs write Products Litigation and Counseling lawyers….
Samsung Bioepis announced positive results yesterday from its exploratory analyses of the Phase 3 study of its biosimilar product, AYBINTIO (bevacizumab). The study compared AYBINTIO’s efficacy to reference bevacizumab in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC). According to Vice President and Team Lead of Medical…
During the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) meeting this July, the CHMP recommended the approval of two biologics and one biosimilar: GlaxoSmithKline’s Blenrep (belantamab mafodotin), for treatment of relapsed and refractory multiple myeloma Novartis’ Adakveo (crizanlizumab), for prevention of vaso-occlusive crises in patients with sickle cell…
On August 25, 2020, the Association for Accessible Medicines filed a new Complaint challenging California’s Assembly Bill 824 (“AB 824”). Enacted in October 2019 and in effect as of January 1, 2020, AB 824 imposes a presumption of anticompetitive effect on certain agreements that involve generic or biosimilar manufacturers and…