On May 24, 2021, Zydus Cadila launched the world’s first antibody drug conjugate (ADC) biosimilar. The drug is a trastuzumab emtansine biosimilar—using Genentech’s Kadcyla as the reference product—that will be marketed under the name Ujvira for use in treating early and advanced HER2 positive breast cancer. The drug is made…
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…
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…