U.S. Biosimilar Regulatory and Launch Updates: Adalimumab, Filgrastim

Below are some recent updates regarding U.S. regulatory submissions and a launch in connection with biosimilar products:

On September 27, 2018, Samsung Bioepis announced that the U.S. FDA has accepted its aBLA for SB5, a proposed biosimilar of Humira® (adalimumab), which Bioepis submitted to the FDA in July.  According to the press release, the application was based on a phase III clinical study of patients with moderate to severe rheumatoid arthritis.  The press release notes that SB5 has already received regulatory approval in Europe, South Korea, Australia and Canada.  Although the FDA’s acceptance of an aBLA is often a triggering event that can lead to U.S. patent litigation, such litigation is not anticipated between AbbVie and Bioepis regarding SB5.  As we reported in April this year, Bioepis and AbbVie have already reached a global resolution of all intellectual property-related litigation relating to SB5 that authorizes Bioepis to launch this biosimilar, if FDA-approved, in the United States beginning on June 30, 2023.

On October 1, 2018, Taiwan-based Tanvex BioPharma announced that it had submitted a BLA to the FDA seeking approval of TX-01, a proposed biosimilar referencing Neupogen® (filgrastim) indicated for chemotherapy induced neutropenia.  According to the press release, Tanvex CEO Dr. Allen Chao hailed the submission as an “exciting milestone” taking “Tanvex one step closer to launching its very first biosimilar product in the U.S. market.”

On October 2, 2018, it was reported that Pfizer has launched Nivestym® (filgrastim-aafi), its FDA-approved biosimilar of Neupogen®, in the United States.  The FDA approved Nivestym® this past July. According to reports, Nivestym® became commercially available in the United States on October 1 at a price 30.3% lower than that of Neupogen® and 20.3% lower than that of Sandoz’s biosimilar Zarxio®, based on wholesale acquisition cost (WAC).