Sarfaraz K. Niazi, PhD, takes a look at the European Medicines Agency's (EMA) announcement that it will investigate whether comparative efficacy tests should be needed for a biosimilar to receive regulatory approval.
It did not take long for the European Medicines Agency (EMA) to act after the FDA held a conference on “Increasing the efficiency of biosimilar development” in September 2023, which was participated by several regulatory agencies and other stakeholders, debating issues relating to removing hurdles in the approval of biosimilars.1
Now, the EMA has issued a call for comments on its intent to create a “Concept paper for the development of a Reflection Paper on a tailored clinical approach in Biosimilar development.”2 While the United Kingdom’s Medicines and Healthcare products Regulatory Agency makes a clear statement both EMA and FDA have stayed reserved in making a clear decision:3
“Although each biosimilar development requires a case-by-case evaluation, in most instances, a comparative efficacy trial may not be necessary if supported by sound scientific rationale. Therefore, a well-justified explanation for the absence of an efficacy trial should be appended to [common technical document] Module 1 of the submitted application.” [sic]
The current initiative by EMA is of high significance since both EMA and FDA have agreed to jointly resolve the inquiries by the developers of biosimilars in “FDA-EMA Parallel Scientific Advice (PSA),” making it likely that the outcome of this Reflection Paper will bring changes at both agencies.4
I have formally submitted my advice to EMA with added information to make this Reflection Paper most useful, as shown below:
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The EMA has taken a significant step in bringing a critical issue to an end. However, the final decisions must rest only on scientific rationale and not on the desire to expedite the approval process; this mandate is necessary to avoid the opposition to waivers of CES. Numerous publications have analyzed this requirement and reported that these studies cannot fail for scientific and statistical reasons, thus categorizing them as inhumane trials.6
It is now well understood, though not established that efficacy testing of biosimilars is a redundant exercise, but gradually, the regulatory agencies are accepting this scientific rationale.7,8
I am encouraging stakeholders to submit their views to the EMA as this comment period remains open till end of April 2024.
References
13 Strategies to Avoid the Nocebo Effect During Biosimilar Switching
December 18th 2024A systematic review identified 13 strategies, including patient and provider education, empathetic communication, and shared decision-making, to mitigate the nocebo effect in biosimilar switching, emphasizing the need for a multifaceted approach to improve patient perceptions and therapeutic outcomes.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
BioRationality: Withdrawal of Proposed Terminal Disclaimer Rule Spells Major Setback for Biosimilars
December 10th 2024The United States Patent and Trademark Office (USPTO)’s withdrawal of its proposed terminal disclaimer rule is seen as a setback for biosimilar developers, as it preserves patent prosecution practices that favor originator companies and increases costs for biosimilar competition, according to Sarfaraz K. Niazi, PhD.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Pertuzumab Biosimilar Shows Promise in HER2-Positive Breast Cancer Treatment
December 9th 2024The proposed pertuzumab biosimilar QL1209 demonstrated equivalent efficacy and safety to reference pertuzumab (Perjeta) in neoadjuvant treatment of HER2-positive, ER/PR-negative early or locally advanced breast cancer, offering a cost-effective alternative with comparable clinical outcomes.
Commercial Payer Coverage of Biosimilars: Market Share, Pricing, and Policy Shifts
December 4th 2024Researchers observe significant shifts in payer preferences for originator vs biosimilar products from 2017 to 2022, revealing growing payer interest in multiple product options, alongside the increasing market share of biosimilars, which contributed to notable reductions in both average sales prices and wholesale acquisition costs.