Amgen, Sandoz, Inc. Biosimilar War Could Provide Playbook, Says Analyst

October 30, 2014

By Riley McDermid, BioSpace.com Breaking News Sr. Editor

The battle over biosimilars is just beginning and the skirmish between biotechs Amgen and Sandoz is creating some fascinating legal problems, said Joshua Schimmer, a biotech analyst at Piper Jaffray & Co., on Thursday.

Schimmer points to a recent blog post from legal expert Kurt Karst that highlights a recent complaint in which Amgen alleges that Sandoz has not followed the appropriate legal steps required under the Biologics Price Competition and Innovation Act biosimilar legal framework. In that case, Amgen is seeking injunctive relief and “could be positioned to postpone the entry of the biosimilar Neupogen” if its action is successful, said Schimmer.

“It is unclear to us what level of success Amgen will meet, but it's yet another opportunity being overlooked by investors (along with its challenge to the entry of other PCSK9 antibodies) that could yield meaningful upside if the company is successful,” wrote Schimmer in a note to investors.

Perhaps more importantly, it is a great example of the the biosimilar "patent dance" that is being played out around the biotech global community. The small molecule generic pathway has the Orange book and a clear framework for patent challenges. In the U.S., the BPCIA lays the framework for biosimilars which includes communication between the biosimilar and innovator companies around the patents and processes used to verify whether or not patent infringement may be occurring.

But it looks like Sandoz may have run afoul of those guidelines after the FDA accepted its Neupogen biosimilar 351(k) application.

“Sandoz was supposed to initiate the information exchange with Amgen but failed to do so according to Amgen’s filed injunction. Sandoz suggested an information exchange that was outside the regulatory framework, which Amgen rejected. In response, Sandoz indicated they would forgo the patent/information exchange process,” explained Schimmer.

This is crucial because the patent Amgen is claiming Sandoz infringes is a “use” patent, issued in Dec. 2000 (filed Nov. 1998), which means it still has a few years of validity. “Not a big difference, but enough to provide added time for the evolving pipeline portfolio to gain commercial traction, in our view,” said Schimmer. “Karst notes that Amgen is also alleging ‘conversion,’ which is essentially intellectual property theft around the Neupogen brand -- not typically seen in biopharma.”

The battle between Sandoz and Amgen will be closely watched by Wall Street and biotech workers alike, because it could outline some key strategies larger companies will use to protect their blockbuster drugs—and how legal tussles might play out in the courts.

“Amgen continues to impress us with its preparedness to challenge biosimilars and pursue all avenues to defend its territory,” said Schimmer. “While unclear if this will be successful or not (or what the implications may be for other biosimilar franchises), it at least highlights some uncertainty around the path to market and freedom to operate for these biosimilar players, many of which are taken for granted by investors.”