As we posted previously, Biocon and Mylan are jointly developing a pegfilgrastim biosimilar, and have sought marketing authorization in the US. On October 10, Biocon reported that the FDA issued a Complete Response Letter (CRL). According to Biocon, the CRL relates to “pending update of the BLA with certain CMC data from…
We previously reported that on October 6, 2017, Amgen filed a declaratory judgment action against Genentech regarding Amgen’s recently approved biosimilar of Avastin® (bevacizumab-awwb). On the same day, Genentech filed a complaint in the District of Delaware, Civil Action No. 1:17cv1407. While the complaint was filed under seal, according to a motion to transfer…
On Friday, October 6, Amgen filed a complaint in the Central District of California seeking a declaratory judgment against Genentech that Mvasi® (bevacizumab-awwb), Amgen’s recently approved biosimilar of Avastin®, does not infringe 27 patents, that those patents are invalid, and that one of the patents is unenforceable for inequitable conduct….
As we reported earlier this year, on January 5, 2017, Judge Robinson of the District of Delaware entered a permanent injunction prohibiting the sale of Sanofi and Regeneron’s Praluent® (alirocumab) product after the defendants stipulated to infringement of the asserted claims of the patents and a jury found the claims…
As we noted earlier today, this week the Federal Circuit is holding oral argument at various venues in New York City. Two of today’s oral arguments were in biosimilar cases that we have been closely following on this blog. Janssen v. Celltrion The morning began with a panel of Judge…
Last Friday, Samsung Bioepis filed IPR2017-02139 and IPR2017-02140, directed to Genentech’s U.S. Patent No. 6,407,213. According to the petitions, the ‘213 patent claims are directed to “humanized antibodies with non-human residues in the Complementarity Determining Regions (‘CDRs’) as well as in the framework region at certain, specified positions.” The petitions…
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…
Today Sandoz filed IPR2018-00002, directed to AbbVie’s U.S. Patent No. 9,512,216. According to the petition, the ’216 patent claims a subcutaneously-administered dosing regimen for the anti-TNF-α antibody adalimumab, the active ingredient in AbbVie’s Humira ® product, to treat moderate to severe chronic plaque psoriasis. This is the second petition Sandoz…
Last week, FDA issued its latest draft guidance on biosimilar products and implementation of the BPCIA. The draft guidance, titled Statistical Approaches to Evaluate Analytical Similarity, “describes the type[s] of information a sponsor of a proposed biosimilar product should obtain” to support a showing of analytical similarity to a licensed…
Amgen has announced that it has settled all pending patent litigation regarding AMJEVITA, its biosimilar version of AbbVie’s Humira® (adalimumab). Amgen reports that AbbVie will grant patent licenses for the use and sale of the product worldwide, on a country-by-country basis. Amgen states that it expects to launch its product in…