Explore the regulatory pathways for biosimilars across the US, Europe, and Asia. Understand the approval processes, challenges, and unique guidelines for successful biosimilar marketing.
When it comes to bringing biosimilars to market, pharmaceutical companies have one enemy harder than any other: the regulatory pathways that they need to understand and navigate.
This article is a round-up of the various regulatory environments for biosimilars as seen from US, Europe, and Asia!
Biosimilars at a Glance
Biosimilars are biologic products that are developed to be highly similar and clinically equivalent to other licensed biologics known as reference products or originators. This reference products are larger molecules, biologically produced by living organisms and are different in many aspects from regular small-molecule drugs.
Because of this complexity, biosimilars are not genetically identical to the reference product; instead, they must show similarity in safety, efficacy and quality.
With the increasing need for more accessibility and considerably cheaper biologics, biosimilars have been a key area for drug manufacturers globally. Yet the road to biosimilar approval is vastly different per geography and any company looking at a global launch must know the law of that land before marketing its product.
Comparing Regulatory Pathways
Biosimilar Approval — The FDA in the US The Biologics Price Competition and Innovation Act (BPCI Act) of 2009 established an abbreviated approval pathway for biosimilars to promote competition between proprietary products and their generic analogs, while ensuring that the rights of sponsors are protected.
The key steps in the FDA biosimilar approval process include:
a. Analytical Studies – manufacturers must provide a large amount of analytical data demonstrating the similarity of the biosimilar and reference product.
b. Preclinical and Clinical Studies: Rigorous pre-clinical (e.g., pharmacokinetic/pharmacodynamic) and clinical evaluations are needed to demonstrate evidence of safety, bioactivity, and positive patient outcomes for these public health interventions .
c. Comparative Use Studies: All manufacturers need to conduct comparative use studies to evaluate differences in safety, purity, and potency between a biosimilar and the reference product under actual conditions of use.
d. Biosimilar Names: Non proprietary name with unique four letter suffix specific to biosimilars approved in US, differentiating them from reference product.
Biosimilar approval in Europe is overseen by the European Medicines Agency (EMA). The pathway for biosimilars in Europe is one of the most advanced worldwide. Highlights of the biosimilar drug approval process of EMA are:
a. Full Medicines Approval: The EMA carries out a comprehensive scientific assessment to establish similarity with the reference product using analytical data and clinical trial
b. Availability of extrapolation: Extrapolation means that the EMA permits a biosimilar to be approved for indications beyond those being studied, based on clinical experience with one indication of the reference product.
c. Biosimilar Nomenclature: In Europe, biosimilars bear the same International Non-proprietary Name (INN) as the reference product highlighted because of the high degree of similarity.
Asia (Different Regulatory Frameworks — Example follows
There are multitude of pathways across Asia for biosimilar regulation and each country /region has a unique set of rules and guidelines. Known as trailblazers, these are countries that have sophisticated biosimilar regulatory frameworks that closely mirror EMA or FDA guidance, as seen in South Korea and Japan. China and India, by contrast, have tried to forge their own ways.
South Korea: South Korea’s Ministry of Food and Drug Safety (MFDS) has taken a prescription approach to biosimilars by closely mirroring the EMA process.
Japan: The Pharmaceuticals and Medical Devices Agency (PMDA) of Japan have put in place a strict pathway for the approval of biosimilars that includes thorough investigations into analytical, functional and clinical similarity.
The China National Medical Products Administration (NMPA) has been establishing its biosimilar regulatory pathway to match international standards over the years.
India: Indian regulatory framework is in initial stages of evolution and emphasizes on analytical data and comparative studies.
Challenges and Considerations
Although biosimilars hold great promise, there are a number of hurdles that pharma companies must overcome to successfully navigate the disparate global regulatory landscape such as:
Data Requirements: These typically require extensive amounts of data for every regulatory body, which is demanding in terms of resources and time.
Ultimate Extrapolation: An essential for biosimilars in order to unlock their full potential on the market
Naming Conventions: Each region of the world has its own naming guidelines (i.e., INN in Europe vs unique suffix in US)
Utilizing Local Expertise — using local experts or strategic partners who understand the regulatory pathways unique to regional nuances can be priceless.
Conclusion
Biosimilars present a crucial chance to allow the pharmaceutical industry to offer cheaper biologics for patient therapy. But doing so successfully all around the world can be a tricky and complicated business, it requires experience and an ability to adapt to different rulebooks.
The regulatory pathways are not universal but specific to the United States, Europe, and Asia. There are different considerations for European Medicines Agency (in Europe) vs AMDC for Asian markets in terms of naming etc. From the FDA analytic inquisition to the EMA’s broader focus on extrapolation to Asia evolving regulatory framework, a nuanced understanding of each pathway is added layer of approval complexity.
BioBoston Consulting assists pharmaceutical companies in navigating the intricate state of regulations in the life sciences field.
Reach us today at BioBoston Consulting or check our website to find out about how we can help your organization.
