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WHO Survey Identifies Global Regulatory Challenges for Biosimilars


A survey of 20 countries highlights the remaining regulatory challenges facing biosimilar adoption.

In 2009, the World Health Organization (WHO) Expert Committee on Biological Standardization created a set of recommendations and guidelines to help its member states implement regulation of biologics and biosimilars. However, member states still face regulatory challenges, based on a 2019-2020 WHO survey of participants in 20 countries. The WHO report on this recommends steps to overcome these challenges.

Progress has been made since an earlier, 2010 survey, the authors said. The challenges identified in the 2010 survey have largely been resolved, but the 2019-2020 survey identified 4 remaining challenges: unavailability or insufficient reference products in particular countries; lack of resources; problems with the quality of some biosimilars; and difficulties with interchangeability and naming of biosimilars.

The authors recommended potential solutions, noting that resolving these challenges will require cooperation between regulatory authorities in different countries. Their proposed solutions included exchanging information on biologics with other regulatory authorities, avoiding unnecessary duplication of studies by accepting foreign-licensed and -sourced reference products, relying on approvals from other regulatory authorities or using joint review to facilitate approval of biosimilars, reassessing products approved before the biosimilar regulatory framework was in place, and establishing regulatory oversight for good pharmacovigilance.

Challenges Associated With Reference Products

The authors noted that many of the challenges identified by the 20 surveyed countries were related to reference biologics, including limited access to information on the reference biologic, financial constraints due to the price of the reference biologic, and difficulty of obtaining reference biologic samples to assess comparability.

The authors noted some countries accept reference biologics that are foreign-licensed and -sourced, whereas others require a domestically licensed reference product or bridge studies for a foreign-sourced reference product. The authors commented that bridge studies are costly and often result in unnecessary duplication of studies.

To address these challenges, the authors recommended exchanging information with other national regulatory authorities, accepting foreign-sourced reference products, and avoiding unnecessary bridge studies. They said, “if data and information are available in the public domain and are sufficient to establish this bridge, the additional study might be waived and would result in reducing the cost of biosimilar development.” They noted that some countries have already implemented information-sharing processes with other national regulatory authorities.

Lack of Resources

Insufficient resources for national regulatory authorities were a commonly cited challenge. The authors commented that building capacity and expertise in a national regulatory authority is “a lengthy process,” and shorter-term measures are needed, such as reliance on information from other regulatory authorities or a joint review process. Some countries have already implemented these strategies to facilitate the biosimilar approval process. Ghana, India, Iran, Jordan, Malaysia, Peru, and Zambia rely on the expertise of other countries which have previously approved reference biologics and biosimilars. Joint review to share the work between regulatory authorities has been implemented in Africa. The authors recommend using these short-term measures to improve efficiency of biosimilar approvals.

Quality of Biosimilars

In some countries, there are biosimilar products on the market that were approved prior to the establishment of a regulatory framework for approving biosimilars. This has led to problems distinguishing between “real” biosimilars and what the authors called “nonbiosimilar, noninnovator products.” The authors recommended reassessment of these products with regard to the established biosimilar approval process. They noted that several countries have already begun reevaluating nonbiosimilar, noninnovator products.


According to the authors, “the hottest topic in biosimilars has moved on from establishing a suitable regulatory framework to the practice of interchangeability.” They noted that the FDA’s requirements for interchangeability “are very challenging and no such products have been approved by the FDA to date.” They report each regulatory authority has its own approach, but no other national regulatory authority has adopted the FDA approach. Only Iran and Japan establish interchangeability immediately upon approval of the biosimilar, with most other countries either relying on the decision of prescribers or basing the decision on clinical evidence provided by the manufacturer.

The authors cited interchangeability as a difficult issue, especially for health care professionals. They argued interchangeability is “more of an issue to be considered and decided by physicians and patients rather than a regulatory issue,” and that “the role of regulatory authorities in this is to inform physicians and patients about the regulatory assessment and decision as a prerequisite for switching products on the market.”

Naming of Biosimilars

The authors pointed out “there is still no consensus among countries on the naming and labeling of biosimilars,” and the WHO does not provide specific nomenclature for biosimilars. They reported many countries use the brand name and international nonproprietary name (the same name as the reference biologic), while others use a suffix or other identifier as part of the name.

The authors stressed that naming and labeling are important for good pharmacovigilance, which is “essential for establishing the safety and efficacy of interchangeability of biosimilars.” There are concerns, they say, about “prescription mix‐ups, unintentional switching, and questions on traceability.” To address these concerns, the authors recommended biosimilars be clearly identifiable, using a unique brand name with the international proprietary name, and the lot number be provided.


Kang HN, Thorpe R, Knezevic I, et al. Regulatory challenges with biosimilars: an update from 20 countries. Ann N Y Acad Sci. Published online November 21, 2020. doi:10.1111/nyas.14522

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