The FDA released draft guidance on the interchangeability between branded products and biologics. Learn more.

View as webpage.

hpw - topbar hpw - topbar - diag hpw - topbar xce

Jan. 20, 2017


Forward to a Friend



View Archived Issues


FDA Flurry of Releases: First Up, Interchangeable Biosimilars


This week, the Food and Drug Administration (FDA) released draft guidance on how companies can demonstrate interchangeability between biological products and branded counterparts. A biological product deemed interchangeable with a branded product may be automatically substituted for the branded product when a prescription is written for the branded product.

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) created an abbreviated licensure pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed biological reference product. To demonstrate interchangeability of a biological product to a branded product, the BPCIA states that companies should submit an application to support that the biological product:

  • Produces clinically similar results to the branded product if given to any patient (ie, biosimilar), and
  • Will not add additional risk in regard to safety or lowered efficacy if a patient switches between the biological product and branded product (for products that are administered more than once)

The draft guidance provides an overview of the scientific evidence manufacturers should consider for inclusion on the application to support interchangeability, including:

  • Data and information needed to support a demonstration of interchangeability
  • Considerations for the design and analysis of a switching study or studies to support a demonstration of interchangeability
  • Recommendations regarding the use of a US-licensed reference product in a switching study or studies
  • Considerations for developing presentations, container closure systems, and delivery device constituent parts for proposed interchangeable products

Companies are not required to submit an application for a proposed interchangeable product for all of the branded product’s approved conditions of use, but it is recommended.

In a discussion of interchangeability, Leah Christl, Associate Director for Therapeutic Biologics and lead of the Therapeutic Biologics and Biosimilars Staff in the Office of New Drugs, commented how the data needed to demonstrate interchangeability will be determined on a case-by-case basis and that “no single data package that will work for all proposed interchangeable products.”

The FDA is seeking general comments on its draft guidance document and comments on how to regulate interchangeable products if there are manufacturing changes to an approved interchangeable product or if there are changes to a branded product’s approved conditions of use after the interchangeable counterpart is approved. The public has until March 20, 2017 to submit comments and suggestions.

Biosimilars determined to be interchangeable can potentially change the current biosimilar market. Payers would have a stronger clinical argument for covering only the interchangeable, and pharmacists could potentially substitute an interchangeable for a prescribed biologic without consulting the ordering physician. And patients—representing perhaps the greatest hurdle—might be more comfortable using an interchangeable than a biosimilar.


Coverage All Around: Update on ACA Repeal and Replace


Over the weekend, President Trump said a plan to replace the Affordable Care Act (ACA) and provide “insurance for everybody” was almost complete. No additional details were announced. Of course, the political frenzy started immediately, not only because a plan (which no one has seen) is proclaimed as done, but also because of the implication that it will provide universal coverage, which is, traditionally, the stomping ground of Democrats. President Trump backpedaled later in the week saying that the idea would be to provide everyone access to coverage. He has said details of the plan will be made available after Tom Price is confirmed as the head of the Department of Health and Human Services (HHS).

On Wednesday, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing on Tom Price (R-GA)’s nomination to head HHS. The hearing was lively, with Republicans and Democrats taking their predicted stances. Republicans hailed the nomination and emphasized the potential of health savings accounts. Democrats focused on potential financial conflicts of interest and patient gains through ACA coverage and what guarantees might be put in place for the future.

Responding to questions from Bernie Sanders on access, Price said, “I believe and I look forward to working with you to make certain that every single American has access to the highest-quality care and coverage that is possible.” But, as Sanders said when pushed back, “access” is not “coverage.” The committee does not vote on his nomination; that responsibility belongs to the Senate Finance Committee, which will hold a hearing on January 24 and then vote on whether to send the nomination to the full Senate for a vote.

In his prepared testimony, Tom Price said, “We all want a healthcare system that’s affordable, that’s accessible to all, of the highest quality, with the greatest number of choices, driven by world-leading innovations, and responsive to the needs of the individual patient.” And he’s right. It is how we get there that is the question.

One interesting note: Republicans are hearing more outrage than they might have anticipated, with patient protests in favor of the ACA at town halls and in the media stating that they might not be alive without Obamacare. The protest stands in sharp contrast to what they likely expected to hear (and what they heard in the summer of 2009 when ACA discussions were kicking off). 

SPOTLIGHT ON... Manufacturer Communications With Payers

Can We Talk? FDA Releases Draft Guidance About Manufacturer Communications on HCEI


On Wednesday, the FDA released long-awaited draft guidances focused on manufacturer communications regarding approved and unapproved uses of their medical products and healthcare economic information (HCEI). Additionally, it re-opened a comment period for a November public hearing regarding unapproved uses of approved or cleared medical products.

Click here to read the latest on the FDA thinking about manufacturers’ communications with payers and other entities about HCEI and approved and unapproved uses of their products.


Supreme Court to Hear First Biosimilar Case


The Supreme Court announced this week that it will hear Sandoz v. Amgen, the first case focused on biosimilars to reach the high court. The court will consider if the 2 central issues of the appeals case are in violation of BPCIA.

As previously reported by Health Policy Weekly, the Federal Circuit issued a split decision in July 2015: 1) it supported Sandoz’s position that biosimilar manufacturers’ engagement in the patent dance is optional; while 2) it supported Amgen’s stance that biosimilar manufacturers must wait until after FDA approval before giving brand manufacturers a 6-month notice of commercial marketing.

Based on a request made in June, the solicitor general weighed in last month with a brief supporting Sandoz on both issues and encouraged the Supreme Court to overturn the Federal Circuit court’s decision on the 180-day notice. Sandoz has argued that this notice effectively gives brand companies an additional 6 months of marketing exclusivity. The ruling is likely to have broad implications for the timing of new biosimilars being launched with respect to their FDA approval date.


Not So Easy: CBO Throws Cold Water on Repealing ACA


The Congressional Budget Office (CBO) issued a report on Tuesday modeling the effects of repealing the ACA via a Republican bill from 2015, the Restoring Americans’ Healthcare Freedom Reconciliation Act of 2015 (HR 3762). According to the CBO, HR 3762—passed without a replacement—would leave 32 million people uninsured by 2026.

CBO estimated that 18 million people would become uninsured in the first year, and premiums would rise 20% to 25% for individual policies purchased through marketplaces or directly from insurers. Once Medicaid expansion and the insurance-exchange subsidies were eliminated, 27 million people would become uninsured.

Senator Orrin Hatch (R-UT) observed that the numbers represented “a one-sided hypothetical scenario. Today’s report shows only part of the equation—a repeal of Obamacare without any transitional policies or reforms to address costs and empower patients. Republicans support repealing Obamacare and implementing step-by-step reforms so that Americans have access to affordable healthcare.”

Republicans are finding it is much easier to oppose legislation than to dislodge something that’s had 7 years to present itself to Americans. Of course, the new Congress has just started and the work to repeal and replace will continue.


Patient Advocacy Organizations, Industry Funding, and Potential Conflicts of Interest


In recent years, healthcare has seen a greater push toward showing the financial relationships existing with various entities within healthcare. Enactments such as the Physician Payments Sunshine Act were designed to provide transparency around the financial relationships among physicians, teaching hospitals, and manufacturers of drugs, medical devices, and biologics.

One area that has received less attention is patient advocacy organizations (PAOs). The primary functions of a PAO are to provide direct counseling for patients, engage in policy advocacy, and shape research agendas. In essence, PAOs such as the American Cancer Society, the American Heart Association, and many others act as advocates for the patient populations they serve. As such, they are influential stakeholders in health and healthcare.

This week, JAMA Internal Medicine reported on a survey conducted from September 2013 to June 2014 that found 67% of a national sample of PAOs were virtually all not-for-profit but reported receiving funding from for-profit companies. Twelve percent received more than half their funding from industry; a median proportion of 45% of industry funding was from the pharmaceutical, device, and biotechnology sectors.

Given the role PAOs play in influencing health policy, public education, and research, there may be efforts to require greater transparency and robust conflict-of-interest policies and practices. As other areas of healthcare have come under scrutiny, PAOs may find themselves subject to the same level of transparency.


Information Buffet (AKA, Other Stuff That Caught Our Attention)


We kept running into stories we wanted to bring to your attention, so here’s a quick hit list of other news we thought you should know:

  • Changing of the Guard: Patrick Conway is serving as Acting Administrator for the Centers for Medicare & Medicaid Services (CMS) following the departure of Andy Slavitt at noon today
  • Oh, No You Don’t: A federal court has temporarily blocked an effort by North Carolina Gov. Roy Cooper to expand Medicaid under Obamacare
  • Oh, No You Don’t, Part Deux: Judge blocks rule that could limit premium assistance for dialysis patients
  • Paint by Numbers: Health policy analyst Chris Jacobs, Founder and CEO of Juniper Research Group, released a 14-page report reviewing more than a dozen regulatory and legislative mechanisms Republicans could deploy to dismantle the ACA
  • A Quality Pick: The National Quality Forum (NQF) Board of Directors has selected Shantanu Agrawal, MD, as the organization’s new president and chief executive officer. Dr. Agrawal is the former deputy administrator and director for CMS’s Center for Program Integrity
  • Not a Pain to Track This: CMS has released the second annual Medicare Part D Opioid Prescribing Mapping Tool, which  shows geographic comparisons at the state, county, and ZIP code levels of de-identified Medicare Part D opioid prescription claims within the US
  • One Step Closer: On Tuesday, CMS announced applications for Section 1332 waivers from California and Alaska have been deemed complete, starting the 180-day period in which federal officials can decide whether to approve them
  • More Time for Hospitals: CMS extended the deadline to March 13 (from Feb. 28) for hospitals to submit data on meaningful use and the Hospital Inpatient Quality Reporting program
  • Expanded Use of Prescriptions: The National Bureau for Economic Research published a working paper studying how Medicaid expansions have affected aggregate prescription drug utilization

The Affordable Care Act Repeal/Replace/Delay Cheat Sheet


Republicans in Congress have attempted to repeal the ACA more than 60 times since 2010, but always with the safety net of knowing President Obama would veto the repeal.

Now, with a GOP-controlled House of Representatives and Senate and a Republican President who campaigned on repealing “Obamacare,” the potential for undoing the ACA just got real.

And so did the follow-up question—what comes next?

For our full and complete cheat sheet to the ACA repeal efforts, click here.





Comparison of Biweekly Open Enrollment Snapshots for, 2016 Enrollment and 2017 Enrollment


“Our Department shines the brightest when we connect those Americans with the realities of the challenges and opportunities ahead. We fulfill our mission every time we help the American people have real conversations about the real choices they face. Whenever we put the American people at the center of their decisions and empower them, our nation grows stronger. That has been our goal at the Department of Health and Human Services throughout President Obama’s Administration, and I hope it continues to be the legacy of this Department well into the future. It has been a privilege to serve with this team.”

– HHS Secretary Sylvia Mathews Burwell, Cabinet Exit Memo, January 5


12 Million | $26 Billion | $2,272


CMS issued a press release last Friday stating that more than 11.8 million Medicare beneficiaries have received discounts of over $26.8 billion on prescription drugs—an average of $2,272 per beneficiary—since the enactment of the ACA

Source: “Nearly 12 million people with Medicare have saved over $26 billion on prescription drugs since 2010,” CMS, January 13


MGMA 2017 Financial Managment and Payer Contracting Conference

February 19–21 l Las Vegas
The MGMA Financial Management and Payer Contracting Conference brings together medical practice management professionals for the financial education that is essential to leading their organizations. Whether you’re new to practice management or you’ve been in the field for several years, building your financial acumen is essential to enhancing your practice’s operations and improving its performance. Meet Xcenda consultants at booth #403. Learn more


AMCP 2017 Annual Meeting

March 27–30 l Denver, CO
Join leaders from AmerisourceBergen, US Bioservices, and Xcenda in Denver, Colorado for the 29th Annual AMCP Meeting and Expo at booth #513. Learn more about the integrated solutions and insights that will drive success across healthcare delivery.  Learn more


Count on Health Policy Weekly for an at-a-glance view of legislative and regulatory developments and news that impacts the healthcare industry.


Jennifer Snow
Health Policy

Scott Shields
Associate Director,
Health Policy



Peyton Howell, MHA
President | Global Sourcing & Manufacturer Relations | AmerisourceBergen Corporation

Amy Grogg, PharmD
Senior Vice President | Strategy & Commercialization | AmerisourceBergen Specialty Group

Loreen Brown, LMSW
Senior Vice President | Product, Strategy & Commercialization Excellence | Lash Group

Tommy Bramley, PhD, RPh
President | Xcenda

Stacie Heller
Vice President | Government Policy | AmerisourceBergen Corporation

Rita Norton
Senior Vice President | Government and Public Policy | AmerisourceBergen Corporation

Ana Stojanovska
Vice President | Reimbursement & Policy Insights | Xcenda


Deanna Gill | Marla Kugel | Jennifer Le | Scott Shields | Jennifer Snow


Brianna Faulkner Hutchinson | Kylie Matthews | Ellen Olson | Adam Mathieu


Jan. 20, 2017


Forward to a Friend



View Archived Issues


Connect with AmerisourceBergen:   I   LinkedIn   I   Twitter   I

Connect with Xcenda:   I   LinkedIn   I  Twitter