2016 was a record year for the development of biologics in the United States.  Below, we summarize a few key biosimilar developments to keep an eye on in 2017.

SCOTUS Review of Amgen v. Sandoz

  • In 2016, Amgen, Apotex, and Sandoz separately petitioned the Supreme Court for certiorari to clarify several BPCIA provisions, specifically questioning the mandatory nature of the patent dance and the notice provisions.  In early January, the Court announced that it will hear the Amgen v. Sandoz case.  The Solicitor General has already weighed in, arguing that an injunction is not proper to enforce Section 262(l)(8)(A).  Instead, a sponsor’s sole recourse if a biosimilar applicant fails to provide information under (l)(8)(A) is commencement of a patent-infringement action.  The Solicitor also made recommendations that aligned with Sandoz’s positions, namely, that the Court should find the Federal Circuit’s holding incorrect with respect to the timing of the 180-day notice, arguing that notice is valid if given pre-licensure.  With respect to the disclosure requirement in Subsection (l)(2)(A), the Solicitor recommended that the Court adopt the Federal Circuit’s holding that a biosimilar manufacturer is not required to disclose its aBLA application and manufacturing process information and start the patent dance.  Based on the timing from granted petitions in 2016, we expect guidance from the Supreme Court by summer 2017.

Further Federal Circuit Guidance

  • A number of new appeals in the biosimilar space have been filed at the Federal Circuit, paving the way for further guidance on biologic patents and the BPCIA.  This includes the fully briefed appeal in Amgen v. Hospira over whether a reference product sponsor is entitled to discovery in a BPCIA litigation as a matter of law under the BPCIA, even though such discovery is irrelevant to any currently asserted patent claim.  Janssen has also filed two appeals seeking to overturn invalidity findings in both the district court and the PTAB for a patent covering its Remicade® drug.  And Amgen has appealed the loss of a first wave BPCIA case against Apotex related to biosimilars of Neulasta® and Neupogen®.  These appeals should be resolved in 2017.

More District Court Litigation

  • As more biosimilar players join the field in 2017, district court litigation should see an uptick.  According to DocketNavigator, one case was filed under the BPCIA in 2014, four were filed in 2015, and six were filed in 2016.  Should this trend continue, 2017 should see a number of new complaints filed in district court.

Increased IPR activity involving biosimilars

  • As biosimilar manufacturers attempt to bring their products to market, we expect continued IPR activity involving biosimilar products.  The number of IPR petitions involving biosimilars has grown over the last few years, and in 2016 sixteen IPR petitions involving biologic products were filed.  We anticipate continued, if not increased, IPR activity in the biologic space in 2017 because IPRs present an attractive mechanism for biosimilar manufacturers to challenge the validity of biologic patents with reduced cost and an accelerated time frame as compared to district court litigation.

Fallout from FDA Guidance on Interchangeability

  • The FDA announced plans to issue guidance in demonstrating interchangeability with a reference product in 2016, and just recently released draft guidelines.  This information will assist biosimilar/biobetter manufacturers in the development of interchangeability.  As no interchangeable products have been approved to date, this information will be extremely useful to manufacturers and may lead to the approval of the first interchangeable under the BPCIA provisions in the United States.

FDA Approval of More Biosimilars

  • In 2016, several manufacturers submitted biosimilar applications to the FDA.  For example, partners Merck and Samsung Bioepis announced that the FDA had agreed to review their proposed biosimilar to REMICADE®.  In addition, Coherus filed an aBLA for a NEULASTA® (pegfilgrastim) biosimilar candidate and Amgen and Allergan submitted an application for an Avastin® (bevacizumab) biosimilar. Mylan and Biocon filed an aBLA for a HERCEPTIN® (trastuzumab) biosimilar, which has been accepted by the FDA for review.  Mylan announced it expects a decision from the FDA by September 3rd, 2017.  Sandoz continues to engage with the FDA regarding its pegfilgrastim biosimilar application, Hospira is addressing an FDA response letter from the FDA involving RETACRIT®, a biosimilar for Amgen’s EPOGEN®, and Apotex continued to work with FDA in reviewing its applications for filgrastim and pegfilgrastim biosimilars. Based on this activity, we anticipate the approval of one or more biosimilars in 2017.

More Biosimilars on the Market

  • 2016 saw the introduction of the second biosimilar to enter the U.S. market, with Inflectra® (Pfizer’s biosimilar of Remicade®) joining Zarxio® (Sandoz’s biosimilar of Neupoen®). Although it is difficult to predict, with two other FDA-approved biosimilars (Erelzi® and Amjevita®) and a number of aBLAs in the wings, 2017 may be the year that additional biosimilars launch in the U.S.

We will continue to monitor these and other developments in the biosimilar/biologics area and report on them in due course.