Amgen files FDA petition, lawsuit seeking info on Sandoz biosimilar manufacturing

Sandoz announced in late July​ that the FDA agreed to review its biosimilar application for the anti-invective Neupogen (filgrastim), which is marketed in the EU as Zarzio.

But, according to Amgen, a subsection of the BPCIA (Biologics Price Competition and Innovation Act) makes it clear that if an application is accepted for review, the biosimilar applicant has to provide the reference product manufacturer with the biosimilar application and information fully describing the processes used to manufacture the biosimilar within 20 days of the FDA’s announcing its review.

“Congress chose to create a scheme whereby patents that may be relevant to a biosimilar product and its manufacturing processes are identified through private exchanges of information between the biosimilar applicant and the reference product sponsor​,” Amgen says. “Those exchanges are to commence shortly after FDA accepts a biosimilar application for review and continue concurrently with FDA’s review​.”

Sandoz, however, has said that the disclosures mandated under this subsection of the BPCIA are “optional​” and, according to Amgen, “has chosen to disregard its obligations​” under the subsection.

“As recent events demonstrate, this Congressionally-mandated scheme is at risk of being fundamentally undermined unless FDA acts to ensure that biosimilar applicants make the requisite disclosures​,” Amgen says.

The biotech giant goes further in its condemnation of Sandoz, noting, “it is simply inconceivable that Congress intended to allow biologic applicants to ‘opt out’ entirely from a process that begins with the phrase ‘the subsection (k) applicant . . . shall provide . . .’ and then proceeds to lay out at least sixteen additional steps framed in mandatory terms​.”

Lawsuit​

In addition to the petition, Amgen also recently filed a lawsuit​ against the Novartis unit in the US District Court of California over the biosimilar application.

This is the first lawsuit filed in the US over a biosimilar. The suit alleges that without a copy of Sandoz’s biosimilar application, Amgen has no way to determine the extent to which its patents have been infringed upon.

And according to the BPCIA, Amgen must provide Sandoz with a list of patents that might potentially be infringed upon not later than 60 days after receiving Sandoz’s BLA and manufacturing info.

Amgen further claims that Sandoz “also must provide FDA with notice that a patent infringement action under subsection (l)(6) has been commenced. FDA must then publish in the Federal Register notice of that complaint for patent infringement alerting the public and other potential biosimilar applicants that an infringement action under the statute related to the reference product has commenced​.”

The lawsuit and petition come as Amgen is looking to develop​ its own set of biosimilars and biomanufacturing capacity.