On November 14, 2017, Sandoz announced data from four clinical trials comparing its proposed adalimumab and rituximab biosimilars to their reference drugs, Humira® and Rituxan®. We previously reported that the Sandoz adalimumab biosimilar is currently under EMA review. As we reported here, the Sandoz rituximab biosimilar has been approved by the European Commission…
As we previously reported, the Centers for Medicare and Medicaid Services (“CMS”) has been considering comments on a proposed rule regarding biosimilar payment policies. On Thursday, CMS issued a final rule for the 2018 Physician Fee Schedule, which includes a change to the biosimilar payment policy. Prior to the issuance of this…
Yesterday, Momenta and Mylan reported that initial results obtained from their proposed abatacept biosimilar M834 did not meet primary pharmacokinetic endpoints in a Phase I study comparing the pharmacokinetics, safety and immunogenicity of M834 to US- and EU-sourced ORENCIA in 243 normal healthy volunteers. The Phase I study was a randomized,…
Last year we reported the FDA approval and then U.S. launch of Inflectra®, a biosimilar of Remicade® (infliximab). This week, Pfizer and Celltrion Healthcare have reported that the results of a Phase 3 study of Inflectra demonstrated that “switching patients with Crohn’s disease (CD) to Inflectra from Remicade® (infliximab) led…
A recent study evaluated the efficacy, safety, and immunogenicity of switching from reference infliximab (Remicade®, Janssen Biotech), to the biosimilar SB2 (Renflexis®, Samsung Bioepis), in patients with moderate to severe rheumatoid arthritis. This study was an extension of a multinational, multi-center phase III study of SB2, which had reported results…
On October 23, 2017, FDA announced the release of new educational materials to help health care professionals understand what biosimilars are and how they are approved. The materials include four fact sheets and graphics that provide definitions for relevant terminology, describe the biosimilar approval process, and explain the benefits of biosimilars. FDA also created social media posts for external…
On October 19, 2017, Abzena plc and UGA Biopharma Gmbh announced that their partnership completed development of an NS0 (murine myeloma) manufacturing cell line. This cell line expresses a biosimilar of a therapeutic antibody for multiple sclerosis. While the press release does not disclose the originator therapeutic, it notes the…
Intas, an Indian pharmaceutical company based in Ahmedabad, has launched BEVATAS (bevacizumab), a biosimilar to Roche’s AVASTIN, in India. Bevacizumab is used to treat colorectal cancer, ovarian cancer, cervical cancer, lung cancer and recurrent glioblastoma. Bevacizumab has been available in India since 2004. Intas’s BEVATAS product is priced at 40%…
The Federal Trade Commission (FTC) is hosting a workshop on November 8, 2017 at the Constitution Center in Washington, DC entitled: “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.” The workshop will address, among other things, competition for biologics under the BPCIA framework. The workshop will be…
This week, six Federal Circuit panels will hear oral argument on at various venues in New York City. Two of today’s oral arguments are in biosimilar cases that we have been closely following on this blog. First, at 10:00 AM, a panel will hear oral argument at the U.S. Court…