Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
On May 21, Alvotech announced that it had entered into a license and supply agreement with Dr. Reddy’s Laboratories SA for the commercialization of AVT03, a proposed denosumab biosimilar. Denosumab, sold by Amgen under the...more
On August 7, 2023, Formycon AG and Fresenius Kabi announced that they have reached a settlement with Johnson & Johnson (“J&J”) in the United States relating to FYB202, a proposed ustekinumab biosimilar to STELARA®, marketed...more
In the last week, seven adalimumab biosimilars referencing HUMIRA entered the U.S. market: Boehringer Ingelheim’s CYLTEZO (adalimumab-adbm); Sandoz’s HYRIMOZ (adalimumab-adaz); Organon and Samsung Bioepis’s HADLIMA...more
Last week, Fresenius Kabi announced the launch of STIMUFEND (pegfilgrastim-fpgk), a biosimilar to Amgen’s NEULASTA, in the United States. As we previously reported, STIMUFEND was Fresenius Kabi’s first biosimilar...more
As previously reported, earlier this year Fresenius filed a petition for inter partes review of claims 9-10, 13-21 and 23-30 of Amgen’s pegfilgrastim patent – U.S. Patent No. 9,643,997 (“997 patent”). The challenged claims of...more
Here are our picks for the top-5 biggest deals in the world of biosimilars in 2017...more
Below are some highlights from second quarter earnings reports recently released by biologics and biosimilar companies. ..Coherus reported that it has cash and cash equivalents of $118.3 million as of June 30, 2017 and...more