Premier Presses FDA, FTC for Biosimilar Marketplace Competition

In response to an FDA and FTC open docket regarding biosimilar marketplace competition, Premier submitted comments and recommendations to further promote a robust biosimilars marketplace. 

The letter from Blair Childs, senior vice president of public affairs at Premier, called on the federal agency to support biosimilar adoption, discourage false or misleading communications about biosimilars, and deter anticompetitive behaviors in the biologic product marketplace.

Creating a competitive biosimilar marketplace is essential to decreasing cost of care, Childs stressed in the letter. FDA requires a biosimilarity designation then an interchangability designation, but a parallel review process would streamline the approval process, thereby boosting access to the cheaper alternative to biologics. The review process would also improve the efficiency of biosimilar and interchangeable product development and approval,

Premier also suggested FDA create a parallel review process to permit applicants to seek a simultaneous designation of biosimilarity and interchangeability to create procedural efficiencies and improve access to interchangeable biosimilars, Childs highlighted.

To further streamline the development and accessibility of biosimilars, Premier also urged FDA to expedite review of biosimilars manufactured at the same facility and on the same line as an already internationally-approved biosimilar.

The naming convention, which was finalized by FDA in January 2017, also adds complexity to healthcare systems. This could lead to errors in prescribing medications, which puts patient at risk and confuses decision-making, Premier explained.

The company asked FDA to rescind the current naming guidance and reissue guidance that uses the same international non-proprietary name (INN) for biosimilars as the reference biologics product. Additionally, the agency should provide results from cognition testing that is easily understood and comprehended by healthcare providers, the letter stated. 

Patients may receive the right dose from the wrong manufacturer of a biosimilar due to confusion with naming. Hospitals are unsure how to address these situations and are reporting these as medication errors, which is creating confusion for patients when they are informed that a medication error occurred.

Therefore, Premier suggested FDA develop clear recommendations regarding what constitutes a medication error for biosimilars.

Premier also added additional recommendations for the FDA to improve the efficiency of biosimilar and interchangeable product development including: 

• Prioritizing inspection of facilities for biosimilar applicants
• Developing product-specific guidance for biologics as the FDA currently does for brand small-molecular products to encourage generic drug development
• Increasing patient access to generic and complex drugs
• Developing recommendations for how biosimilar shortages will be addressed and mitigated in an expeditious manner
• Creating guidance regarding the safety concerns associated with white-bagging of biosimilar

Real-world evidence (RWE) is vital to understanding the safety of switching a patient from a reference biologic product to a biosimilar, switching a patient from one biosimilar to another and understanding any challenges that may be associated with maintaining a patient on a reference biologic as variations in lots may occur.

RWE is also vital to assess the cost-effectiveness of a product and understand the total cost of care for certain diseases often treated with biologics and biosimilars. 

“Premier supports the FDA draft guidance on truthful and non-misleading communications regarding biosimilars and encourages FDA to finalize the guidance expeditiously and act upon its intent highlighted in the Biosimilars Action Plan (BAP) to gather RWE to monitor the safety and efficacy of biologics and biosimilars,” Childs highlighted. 

Premier believes that education is crucial to educate healthcare professionals and other stakeholders to discourage false and misleading communications. The company praised FDA for its efforts with the Biosimilar Education and Outreach Campaign and their ongoing commitment to develop other educational materials. 

Specific areas where Premier believes additional education is beneficial to strengthen confidence in biosimilars include interchangeability, which is the ability to perform pharmacist-level substitution of all FDA-approved biosimilars. 

Education around extrapolation is critical to increase provider confidence in prescribing a biosimilar for all FDA-approved indications. Finally, FDA should highlight the safety and efficacy of biosimilars in the European Union to boost provider confidence in prescribing biosimilars.

Additionally, Premier urged both FDA and FTC to work with Congress to make changes to the Orphan Drug Act, end the practice of evergreening, prohibit pay-for-delay arrangements, allow FTC to take civil action to deter drug companies from filing sham citizen petitions to delay approval of competing generics or biosimilars, and create greater transparency to help biosimilar manufacturers understand when patients expire to encourage the entry of less costly into the marketplace.

Additional suggestions included prohibiting rebates on biologics for three years upon market entry of a competitor biosimilar and elevating policy proposals to further encourage the adoption of biosimilars and ensure payment policies are fair and unbiased. 

“In closing, the Premier healthcare alliance appreciates the opportunity to submit comments on FDA-2018-N-2689. Premier looks forward to working with the FDA and other stakeholders to encourage a robust biosimilars marketplace by striking the appropriate balance between innovation, access and competition for biosimilars,” the letter concluded.