Last week the 7th Circuit Court of Appeals heard arguments in UFCW Local 1500 Welfare Fund v. AbbVie Inc., Case No. 20-2402. The appeal concerns the United States District Court for the Northern District of Illinois’ dismissal of a proposed class action alleging that AbbVie, Inc. created a “patent thicket”…
On March 1, 2021, Formycon announced that it plans to resubmit its BLA for its Lucentis® Biosimilar Candidate FBY201 (ranibizumab) in the first half of 2021. Formycon expects to submit its application to the EMA soon thereafter, and will also seek approval in Canada, Australia, the United Kingdom and Switzerland….
Last Wednesday, State Senator Carla Nelson and State Representative Jennifer Schulz of Minnesota announced the introduction of a bill aimed at reducing the price of certain medications by expanding access to biosimilars. The bill requires that pharmacy benefit managers and health carriers must not require or demonstrate a preference to…
On March 1, 2021, the Supreme Court heard oral argument on Arthrex and the constitutionality of IPRs. Listen here for insightful analysis of the arguments from our Supreme Court and IPR experts, William Jay, David Zimmer, and Linnea Cipriano.
On February 18, 2021, the American Journal of Health-System Pharmacy published the results of a meta-analysis evaluating the use of infliximab in patients with rheumatoid arthritis (RA). The meta-analysis evaluated patient response rates to treatment with the infliximab reference product REMICADE compared to treatment with infliximab biosimilars. The study’s authors…
Earlier today, Samsung Bioepis announced the initiation of a Phase 1 clinical trial for SB17, the company’s proposed biosimilar to Stelara® (ustekinumab). The trial will compare the pharmacokinetics, safety, tolerability, and immunogenicity of SB17 and Stelara®. With the start of this trial, Samsung Bioepis has the following biosimilar candidates in…
As regular Big Molecule Watch readers know, the Biologics Price Competition and Innovation Act (“BPCIA”) was signed into law as part of the Affordable Care Act on March 23, 2010, creating an abbreviated licensure pathway for “biosimilar” and “interchangeable” biological products. The BPCIA also introduced a new scheme to resolve…
On February 15, 2021, Celltrion Healthcare announced that the European Commission granted marketing authorization for Yuflyma™ (CT-P17), an adalimumab biosimilar, on February 11, 2021. Yuflyma™ was approved across all thirteen intended indications covered by the reference biologic, Humira®. Yuflyma™ is a high concentration, low-volume and citrate-free adalimumab biosimilar, which, according…
As we previously reported in August 2019, the District Court for the District of Delaware issued an opinion granting Sanofi’s motion for judgment as a matter of law that the asserted claims of two of Amgen’s patents, U.S. Patent Nos. 8,829,165 (the “’165 patent”) and 8,859,741 (the “’741 patent”), covering…
On February 9, 2021, Lannett Company announced that it had added a new co-development agreement for biosimilar insulin aspart with its strategic alliance partners within the HEC Group of Companies. Insulin aspart, currently sold under the brand name Novolog®, is a fast-acting insulin used to treat high blood sugar in…