On a sweltering hot D.C. morning, those of us anxiously awaiting the Supreme Court’s opinion in its first case involving biosimilar biological products finally exhaled. The June 12, 2017 opinion followed the parties’ oral arguments on the last day of the Court’s October 2016 Term, as we previously reported. With respect to both of the significant issues presented, the Justices unanimously reversed the Federal Circuit Court of Appeals split opinion and remanded for further consideration of questions related to State law.

Although our intellectual property colleagues have separately analyzed the “Patent Dance” implications of the Court’s decision in Amgen v. Sandoz (see here), the second issue presented in the case related to the proper interpretation of the 180-day notice provision of the Biologics Price Competition and Innovation Act (“BPCIA”). The Federal Circuit had held that such notice by the biosimilar applicant can only be provided to the reference product sponsor after FDA licenses (i.e., approves) the biosimilar application.  Continue Reading SCOTUS Ruling Gives a Boost to Biosimilars; FDA Continues to Advance Products Through AdComs

SupremeCourt_103670531Regular readers of our blog know that we’ve been following developments related to biosimilar products for some time (see our past coverage here).  On April 26, 2017, the U.S. Supreme Court heard oral argument in its first case involving the Biologics Price Competition and Innovation Act (“BPCIA”), Amgen v. Sandoz.  Our Intellectual Property colleague Thomas Wintner attended the Court’s oral argument (in the “good seats,” no less, as a member of the Supreme Court bar) and prepared a client alert that recaps the argument.  The full client alert is available here.  Stay tuned for further analysis and updates on this important biosimilar case and other developments in the field.

Our long-time readers know that there are many legal, regulatory, and scientific questions surrounding the Biologics Price Competition and Innovation Act (BPCIA), which was passed as part of the ACA and created a new abbreviated FDA licensure pathway for highly similar biological products called biosimilars (see here for our prior posts on biosimilars).  Yesterday, a three-judge panel of the Federal Circuit Court of Appeals issued a unanimous opinion interpreting the BPCIA’s provision that requires biosimilar applicants to give reference product sponsors Notice of Commercial Marketing at least 180 days before market launch of the biosimilar.  The question presented was whether compliance with the so-called Patent Dance provisions of the BPCIA obviates the need for a biosimilar applicant to provide that 180-day notice.  The court stated clearly that the answer to that question is “No” and that notice of commercial marketing is always required after FDA’s date of licensure for the biosimilar.  Our IP colleague Tom Wintner explains the importance of this Amgen Inc. v. Apotex Inc. Federal Circuit decision to the biosimilar industry here.

Here at Health Law & Policy Matters, we continue to monitor the impact of this BPCIA ruling on the biosimilar product pipeline, the wider drug pricing debate, and efforts in Congress to reduce the market exclusivity  period granted by the law to brand name biological products.

In another highly anticipated regulatory move, FDA has released draft guidance on “Labeling for Biosimilar Products.”  Made public on March 31st, the draft guidance sets forth FDA’s recommendations on the labeling of biosimilar products that are approved via the abbreviated licensure pathway created in 2010 by the BPCIA.  The Agency has been under pressure for many months now to issue some sort of policy on biosimilar labeling, whose contours will have dramatic impacts on the growth and development of this industry in the United States.

Many stakeholders have been critical of last year’s final labeling package for Zarxio (filgrastim-sndz), the first biosimilar approved in the U.S., because that labeling was essentially identical to the labeling for the reference filgrastim product, Amgen’s Neupogen.  Biologic manufacturers (such as AbbVie, who in December filed a Citizen Petition with FDA regarding the scope and content of biosimilar labels) have cited concerns that labeling for a biosimilar should not be “the same as” the reference biologic’s label in the same way that generic drug labels are generally the same as their reference listed drug product’s label.  These industry stakeholders, along with certain patient and provider groups, argue that biosimilars should not be treated the same as generic drugs because the statutory standard for FDA approval is that a biosimilar be “highly similar” to its reference and have “no clinically meaningful” differences compared to the reference biologic – a different approval standard than what small-molecule generic drugs have under the Hatch-Waxman Act.  On the other hand, FDA also received another Citizen Petition late last year that requested generic drug-style labeling for the biosimilar class of products.

Therefore, a key aspect of the newly issued draft guidance is the extent to which biosimilar labeling should be consistent with the label of the reference product.  FDA is not requiring biosimilar labels to be identical to its reference product; however, it proposes that biosimilar labels should heavily rely upon their reference products.  Specifically, FDA states in the draft guidance: Continue Reading FDA Differentiates Biosimilar Labeling from Generic Drug Labeling