Denied Again! Another Obstacle to Biosimilar First Launch Falls with FDA Rejection of Amgen’s Certification Petition; Meanwhile, an Appeal is Filed in the Patent Dance Litigation

By James C. Shehan –

Events keep on coming at a furious pace in the biosimilar world, with two new developments in the battle between Amgen and Sandoz over the latter’s hopes to launch its recently approved Zarxio, a biosimilar version of the former’s Neupogen (filgrastim). 

On March 25, 2015 FDA denied an Amgen Citizen Petition that requested FDA to require biosimilar applications to include certifications that applicants will timely comply with section 351(1)(2)(A) "by providing the reference product sponsor with a copy of the biosimilar application and information that describes the process(es) used to manufacture the biosimilar product that is the subject of that application.”  This petition was filed in October 2014 (see our previous post here) and Momenta’s comments opposing it (cited by FDA) were filed the following month.  As summarized by FDA, Amgen’s position largely flows from its interpretation of the statute as making the patent dance a mandatory process, while Momenta’s position is based on interpreting the patent dance as optional.

Having laid out these opposing views, FDA declines to require the certification requested by Amgen while refusing to endorse either interpretation.  Instead, the Agency makes plain that it has no intention of getting involved in a fight that it believes it can avoid.

FDA’s reasoning starts with the wording of the statute itself: “Neither section 351(k) nor section 351(1) requires FDA to impose a certification requirement as part of the biosimilar review process.”  The agency highlights that in this respect the BPCIA is “in contrast” to the Hatch-Waxman Act “Section 505(b) requires new drug application sponsors to identify certain patents for listing by FDA.  Consistent with section 505(b)(1), FDA publishes these lists in its Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book). Sections 505(b)(2)(A) and 505(j)(2)(A)(vii) of the FD&C Act require 505(b)(2) and ANDA sponsors, respectively, to certify each patent submitted for the listed drug referenced in the Orange Book.  Because of this contrast, FDA concludes that imposing a certification “is a matter of regulatory discretion and not compelled under the PHS Act.”  For good measure, FDA asserts that the Amgen petition “implicitly acknowledges” that this is a matter of FDA discretion.

In support of its conclusion, FDA characterizes the patent dance procedures as “parallel to, but separate from, the FDA review process.”  As further support, the Agency notes that the BPCIA “generally does not describe any FDA involvement in monitoring or enforcing the information exchange by creating a certification process or otherwise,” although it does acknowledge grudgingly in a footnote that it has a duty to receive and publish certain patent infringement lawsuit complaints in the Federal Register.  Tying up with a bow its determination to stay clear of patent dance fights to the extent possible, FDA consigns the issue to the judicial system “These competing interpretations of section 351(1) are the subject of litigation that may clarify how section 351(1) should be interpreted.”

Speaking of that litigation (see our posts here, here, and here), Amgen has now filed an appeal to the Federal Circuit of the lower court’s denial of its request for a preliminary injunction to block the launch of Zarxio.  The parties have requested an expedited schedule for the appeal with oral argument projected for June.  Amgen has also requested an injunction during the pendency of the appeal.  Sandoz has agreed to not launch Zarxio until the earlier of May 11th or a Federal Circuit ruling on Amgen’s request for an injunction pending appeal. 

During the long five years between BPCIA passage and Zarxio’s approval, long stretches could pass without significant developments in the US biosimilar world.  It seems that those days are past.