It has been a few months since we reported on Federal Court wranglings with the Biologics Price Competition and Innovation Act, or BPCIA, which created the nation’s abbreviated marketing pathway for biosimilar products.

After the Supreme Court issued its first ruling on the BPCIA in June 2017 (see our prior post here), it sent the dispute between Amgen and Sandoz back to the Federal Circuit Court of Appeals to resolve the question of whether Amgen’s claims asserted under California law, including a claim of unfair competition, were preempted under the BPCIA. Continue Reading Biosimilar Market Developments Continue Apace in 2018

As is the tradition here at Health Law & Policy Matters, towards the end of the year we take stock of what transpired in our respective industries and highlight important legal, regulatory, and business developments.  For those of us who monitor the Food and Drug Administration (FDA or the Agency) and counsel FDA-regulated entities, it has certainly been a whirlwind of a year.

2017 began with no clear picture of who would be assuming leadership of the Agency, but also with a brand-new piece of critically important (and bipartisan!) legislation – the 21st Century Cures Act (see our prior posts here) – which imposed new obligations and authorities on FDA that needed to be implemented, operationalized, and fully funded.  In early May, Dr. Scott Gottlieb was sworn in as the 23rd Commissioner of FDA and he moved quickly to shift policy priorities in almost every area that the Agency regulates, a goal that in some ways was made more efficient due to the concurrent timing of modernization mandates imposed by the Cures Act.  This year’s must-pass User Fee Act, the FDA Reauthorization Act or “FDARA” (see our prior posts here) engendered some hand-wringing and political drama over the summer, but was ultimately passed by Congress in August and signed into law.  FDARA includes some important policy and programmatic changes for new prescription drugs/biologics, generic drugs, and biosimilars, but it did not contain major wholesale reforms to the Agency’s authorities due to the very recent passage of the Cures Act.

This is the first in a series of three installments that will review the actions FDA took in 2017, reflect on what they may mean for regulated industry, and provide a few predictions for 2018.  This first installment, which will be broken up into two posts, focuses on therapeutic products; that is, drugs, biologics, human cells and tissue products, and gene therapies.  Our subsequent posts will focus on medical devices and diagnostics, including whole-genome sequencing tests, and digital health and other software-related developments, respectively. Continue Reading FDA 2017 Year In Review: Therapeutic Products Energized by Cures Act, Bold Leadership

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