To address healthcare system costs, the Biologics Price Competition and Innovation Act established an abbreviated pathway for less expensive copies of biologic drugs called biosimilars. Biosimilars have struggled to penetrate the U.S. market, including those developed by major players. Biosimilars of Remicade (infliximab) have managed to capture only 6% of the U.S. market 21 months post-launch. By contrast, the EU has witnessed a more rapid uptake of biosimilars, likely due to stronger payer control and regulatory guidelines facilitating biosimilar penetration (such as the NHS commissioning framework for biological medicines in the U.K.). In the U.S., the FDA has followed suit by developing the Biosimilars Action Plan (BAP) to strike a balance between innovation and competition in the U.S. biologics market.


Through the BAP, the FDA plans to reform the agency’s regulatory processes governing the development and approval of biosimilars. The BAP also intends to influence behaviors beyond the FDA’s direct control. The BAP ultimately aims to create a competitive market that would deliver benefits to patients and the public while providing incentives to innovation in the biologics space.


The Biosimilars Action Plan focuses on four areas:

  1. Improving the efficiency of the biosimilar development and approval process
  2. Maximizing scientific and regulatory clarity for biosimilar developers
  3. Developing effective communications to improve the understanding of biosimilars among patients, clinicians and payers
  4. Reducing the gaming of FDA requirements as well as attempts to unfairly delay competition


The BAP is poised to affect biosimilar developers, originators and prescribers. Here’s how:

  • Biosimilar developers: The BAP is likely to meaningfully increase the efficiency of the biosimilar development process and streamline biosimilar regulatory review. To achieve this, the FDA plans to introduce tools such as standardized templates for 351(k) BLA, and in silico modeling and simulation to evaluate the PK-PD data for biosimilars, and develop an index of critical quality attributes. While this may encourage biosimilar development, it would not ensure increased market penetration.

    The BAP intends to address persistent regulatory uncertainty by introducing clarity in the biosimilar development process, including guidance to assist biosimilar manufacturers in “carving out” labeling information protected by patents. Although the BAP provides some regulatory clarity, there remains significant uncertainty impeding biosimilar development.
  • Originators: By working in close collaboration with the FTC, the FDA may inhibit originators from employing defense tactics such as rebate traps and exclusive dealings. The BAP may also monitor pay-for-delay agreements that the originators enter with the biosimilar manufacturers to delay biosimilar launch. Looking at the present U.S. market scenario, the question remains whether these measures are enough to stimulate biosimilar penetration.

    The FDA’s Risk Evaluation and Mitigation Strategy (REMS) program has allegedly been misused by the originators to refuse to sell samples of their reference product to biosimilar developers. The FDA has released draft versions of a REMS program and plans to allow non-U.S. license comparators. This would limit attempts of originator companies to delay competition by gaming the agency’s regulations.
  • Prescribers: The FDA has been proactively educating different stakeholders through initiatives like the Biosimilar Education and Outreach Campaign, a program to promote the understanding of biosimilars and interchangeable products. The FDA also plans to exchange real-world evidence around biosimilars via data-sharing agreements with health authorities across the world and through the FDA’s Adverse Event Reporting System (FAERS), Sentinel and CMS locally. These steps could lead to improved stakeholder engagement and build trust in biosimilars.

Stakeholder Reactions


The BAP appears to be well-received by most industry stakeholders. While originators have not overtly welcomed the BAP, they also haven’t been outspoken in their opposition. Biosimilar developers believe that more steps are needed to remove barriers.


While Roche has looming biosimilar competition over some of its blockbusters, the company spokesperson reportedly told BioPharma-Reporter that Roche would look forward to a dialogue with the FDA to “ensure patient choice and access to the treatments they need today as well as a positive environment for scientific innovation that enables the breakthrough of medicines of the future.”


In that same article, a Pfizer spokesperson noted that, “more work needs to be done to tear down market barriers to biosimilars and it will require cooperation from a robust coalition of stakeholders, from Congress and insurers to the FDA, to biologics manufacturers, and the middlemen.”


The American College of Rheumatology (ACR) and other prescribers hope that the pathway for interchangeable drugs is finalized as soon as possible to increase the number of safe and effective options. CMS has also come out in support of the plan, congratulating the FDA on the release of the Biosimilars Action Plan. In its statement, CMS said: “CMS congratulates the FDA on the release of the Biosimilars Action Plan. President Trump has set a clear priority to lower drug prices, and the bold steps in this proposal will do just that while also expanding access for patients. … We look forward to continuing to work with the FDA on the rollout of the American Patients First blueprint.”


The Biosimilars Action Plan enables a streamlined and simpler biosimilar development process. However, it lacks teeth to create a competitive U.S. biosimilars market. Educational initiatives such as those outlined by the BAP also aren’t likely to significantly stimulate biosimilar adoption with payers, patients and prescribers. Broader stakeholder adoption hinges on meaningful incentives to biosimilar use, which has proven to be successful in the EU with programs such as the U.K.’s biosimilar adoption gainsharing policy.

The FDA will need to collaborate with other organizations to stimulate biosimilar uptake as many of the steps needed to drive biosimilar adoption are beyond the FDA’s purview.