Celltrion USA announced on March 18, 2024, the availability of ZYMFENTRA™ (infliximab-dyyb), a subcutaneous (SC) formulation of infliximab. ZYMFENTRA™, approved by the FDA in October 2023, is the first FDA-approved SC infliximab for the treatment of moderately to severely active ulcerative colitis and moderately to severely active Crohn’s disease, with…
As we kick off 2024, we reflect on regulatory developments in the biologics and biosimilars space in 2023. Below are some of the top regulatory developments from 2023. FDA Approvals In 2023, there were 23 FDA approvals of Biologic License Applications, including for Vertex’s CASGEVY and Bluebird’s LYFGENIA, the first…
As we settle into 2024, we reflect on the significant legal developments of 2023 that hold potential impact on the biologics and biosimilars market. The following is a recap of some of the top five legal decisions and developments in the biosimilars and biologics space in 2023 that we covered…
On October 23, 2023, Celltrion announced FDA approval for ZYMFENTRA (infliximab-dyyb), a subcutaneous formulation for maintenance therapy for patients with moderately to severely active ulcerative colitis and Crohn’s disease. Infliximab is a TNF blocking agent that was first approved by the FDA as an intravenous formulation for the treatment of…
In 2017, three indirect-purchaser antitrust class actions were filed against Johnson & Johnson and Janssen Biotech, Inc., alleging that they engaged in anticompetitive conduct relating to the sale and marketing of J&J’s REMICADE (infliximab). The class actions were brought by employee welfare benefit plans, specifically the National Employees Health Plan,…
According to PwC, “2022 has been a challenging year for M&A in the pharmaceutical and life sciences sector, with both deal value and volume at multiyear lows thanks to overall macro headwinds coupled with broad-based market dislocation.” PwC expects “M&A to more closely resemble prior years with a total deal…
On December 22, 2022, Celltrion USA announced that it submitted a Biologics License Application (BLA) for a subcutaneous formulation of infliximab, CT-P13, to the U.S. Food and Drug Administration (FDA). According to Celltrion, the BLA is based on phase III pivotal data that evaluated the efficacy and safety of CT-P13 as a…
Celltrion recently confirmed that it proved the effectiveness of its subcutaneous infliximab biosimilar, RemsimaSC (CT-P13 SC) in two global Phase III trials. The Phase III study was a 54-week study conducted on 438 patients of ulcerative colitis and 343 Crohn’s disease patients. According to Celltrion “[t]he results showed that RemsimaSC…
The Big Molecule Watch is monitoring clinical trial activities involving infliximab. Here we report on recent studies with Celltrion’s INFLECTRA (infliximab-dyyb). Earlier this year, clinical trial data was published from an observational real-world study of patients with inflammatory bowel disease, including Crohn’s disease (“CD”) and ulcerative colitis (“UC”) in the…
On March 24, 2022, Celltrion Healthcare announced that it had won a bid to the Brazilian Federal Government to supply a biosimilar version of Remsima® (infliximab), along with bids to 12 Brazilian states. According to the company, infliximab will be the third biosmilar product that Celltrion is to supply to…