On March 10, Lannett announced that it received feedback from the FDA regarding its insulin glargine biosimilar. Lannett sought and received comments from the FDA concerning the protocol and statistical analysis plan to be used in the pivotal clinical trial for the product. Lannett reported that it incorporated this feedback…
The National Comprehensive Cancer Network® (NCCN) Oncology Research Program (ORP) in collaboration with Pfizer announced this week a list of ten selected organizations and their research projects that have been chosen to receive funding to study the safe, effective, and efficient adoption of biosimilars in oncology: American Society of Clinical…
This month, a working group within the Pharmacy Directors Forum of the National Comprehensive Cancer Network (NCCN) has reviewed and highlighted “some of the potential challenges regarding adopting biosimilars into clinical practice,” making “several recommendations for the safe and efficient use of biosimilar medications in the clinical setting.” The group…
In honor of Women’s History Month, Big Molecule Watch will highlight the work of women who have contributed to the advancement of biologics and biosimilars. One such individual is Janet Woodcock, current acting Commissioner of the U.S. Food and Drug Administration (FDA) and director for Drug Evaluation and Research, who has held a number…
The Senate passed a bill (S. 164) earlier this month (on March 3, 2021) “[t]o educate health care providers and the public on biosimilar biological products, and for other purposes.” The proposed “Advancing Education on Biosimilars Act of 2021” would add a section to the Public Health Service Act on…
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…