Tag: misinformation

FDA and FTC Say They Will Work Collaboratively to Deter Anticompetitive Behavior

A press release from the US Food and Drug Administration and the Federal Trade Commission announced the signing of a joint statement that focuses on anticompetitive behavior in the biosimilar market. According to the FDA and FTC, this statement describes “key steps the agencies will take to address false or misleading promotion about biosimilars within their respective authorities and deter anticompetitive behavior in this space.”

FDA and FTC Collaboration

When introducing the Biosimilar Action Plan in 2018, former FDA Commissioner Scott Gottlieb noted that biosimilar market competition is being hampered by reference manufacturers’ attempts to unfairly delay competition. “Strengthening the partnership and interagency coordination between FDA and FTC will help each agency address and deter anticompetitive behavior in the US market for biological products,” stated the federal agencies today. “Such behavior might include anticompetitive reverse payment agreements, abusive repetitive regulatory filings, or misuse of restricted drug distribution programs.”

Food and Drug Administration

In the press announcement, FDA Commissioner Stephen M. Hahn remarked, “Strengthening efforts to curtail and discourage anticompetitive behavior is key for facilitating robust competition for patients in the biologics marketplace, including through biosimilars, bringing down the costs of these crucial products for patients.”

FTC Chairman Joseph Simons added, “The FTC is committed to continuing to enforce the antitrust laws in healthcare markets, including those for biologics and biosimilars.”

The FDA and FTC have pledged to begin efforts in 4 areas:

  • They will coordinate to promote greater competition in biologic markets.
  • They will work together to deter behavior that impedes access to samples needed for the development of biologics, including biosimilars.
  • FDA and FTC intend to take appropriate action against false or misleading communications about biologics, including biosimilars, within their respective authorities. FDA is publishing a draft guidance outlining considerations for FDA-regulated advertisements and promotional labeling that contains information about biologic products.
  • FTC will review patent settlement agreements involving biologics, including biosimilars, for antitrust violations.

A Real Beginning for the Biosimilar Action Plan?

It is unclear what action(s) will arise from this joint statement. Although a few initiatives have been implemented, such as limiting the ability of Citizens Petitions to delay FDA decision making on biosimilar applications, both the FDA and FTC have not addressed other opportunities to attack anticompetitive behavior in this marketplace.

Legislation, such as the CREATES Act (first introduced in 2017 and is awaiting action in 2020), was intended to address the ability of prospective biosimilar makers to obtain biologic samples from reference manufacturers. It is unclear what teeth FDA or FTC will use to take a bite out of these delaying tactics.

In 2019, the Trump administration backed away from the removal of the drug rebate safe harbor, believing that it might somehow result in higher Medicare premiums. Pfizer’s 2017 lawsuit against Janssen Biotech seeks to address the use of exclusionary rebate contracts. No other significant actions against drug rebates have been taken to date.

The FDA has unintentionally encouraging misinformation by requiring the use of four-letter suffixes for the biosimilars but not their reference products. Interestingly, the FTC disagreed with this policy, and submitted comments to the FDA explaining why it believes this will contribute to misinformation.

The FTC has been opposed to “pay for delay” deals, which have principally been seen in the generic marketplace. Legislators have tried to move proposals through Congress or the Senate that prevent these arrangements, but these have not progressed very far. In the biosimilar arena, licensing arrangements that pay royalties to the reference manufacturer and allow biosimilar firms to start marketing their product after a certain date may not exactly fit this “pay-for-delay” description. Further, some argue that these arrangements may actually create an avenue for earlier access to the less-expensive biosimilar.

Importantly, the FTC has not yet taken any material action to address the anticompetitive patent thickets that prevent marketing of biosimilars for some of oldest biologic agents.

Is this statement by the FTC and FDA a first step in activating the Biosimilar Action Plan? Or is it a first step towards a collaboration that leads to a beginning?

Even Today, Patients and Payers Hold the Key to Biosimilar Uptake Success

Reading the white paper co-published March 19 by the US-based Biosimilars Forum and UK-based Medicines for Europe highlighted for me the importance of an essential roadblock to increased biosimilar uptake in the US.

The white paper outlined structural market changes needed in the US to gain comparable conversion of marketshare in the European market. Without a doubt, barrier number 1 is the patent thicket erected by biologic makers and the resulting patent litigation. This causes barrier number 2: the signing of licensing arrangements that prevent biosimilar makers from entering the market at the earliest possible date.

However, this still doesn’t address the lack of biosimilar uptake for infliximab: Inflectra® has been available for use since 2016. Whereas I placed considerable blame for this on Pfizer, which underestimated payers’ reaction to its initial discount on Inflectra. Today, I place more of the responsibility on the health plans and insurers for lacking the backbone needed to ensure a vibrant biosimilar market for infliximab. The health system can gain the greatest savings by converting to biosimilar infliximab compared with any currently launched biosimilar. With that in mind, let’s consider these agents.

According to the white paper, “Full buy-in is needed from payers to sustain a competitive market that values the most cost-effective medicines. This includes proactive incentivizing of biosimilar prescriptions, educating stakeholders on the promise of biosimilars, and requiring commercial insurers to provide access to biosimilars.”

I will take this one step further. Patients need to act on their desire for less-expensive alternatives at the physician’s office. Two things must occur to produce this result: (1) the provision of more accurate, less misleading information to patients relating the quality of biosimilars and their clinical efficacy and safety, and (2) financial incentives for patients to specifically request biosimilars.

There is no question that patients are often confused by the contradictory information they receive on biosimilars. This harkens back to generic–branded drug battles of decades ago. Without accurate education, patients will not reliably consider a biosimilar alternative to products like Remicade® . Much has been published on this issue already, and several biologic makers have been castigated about their contributions to misinformation. This must intensify if the second “pull-through” for biosimilar uptake is to be successful.

Any American patient who has faced high cost sharing or deductibles has considered ways to lower his or her costs. That includes making the decision to not refill their prescription or take their medications as directed. Infliximab is only available today as an office-based infusion, but should a subcutaneous version be approved, this, too, would be more directly in the patient’s hands.

The only way this will occur is if patients are given an appropriate choice by their health plans and insurers: lower cost sharing for biosimilars. This is accomplished easily, through the creation of a specialty biosimilar tier (or assignment of biosimilar agents on a fixed cost, tier 3–type payment). With the reference product strictly on tier 4 or 5 (co-insurance tiers with high dollar maximums), this would be the practical step to move the needle. For Medicare Part D beneficiaries, this could be as high as 33% co-insurance.

With the exception of very few payers, this has not occurred for Inflectra. It did occur for Zarxio®, as early as 2017, but it is not used for a chronic medication. When patients begin asking for lower-cost alternatives and payers provide cost-sharing structures that favor biosimilar use, Inflectra or Renflexis® uptake will begin to increase. That means payers foregoing short-term rebate revenue for longer-term cost savings. But one cannot occur without the other.