Sandoz's Francisco Ballester Discusses Biosimilars in Emerging Markets

While much attention in the biosimilars world is paid to the experienced European market and to the more turbulent but growing US market, less conversation surrounds emerging markets, though these regions are equally—if not more so—in need of the savings and increased patient access that biosimilars provide.

During the inaugural Biosimilars Commercialisation Summit, held May 14-15, 2019, in Amsterdam, the Netherlands, Francisco Ballester, MBA, head of the international region for Sandoz, discussed some of the key considerations that biosimilar developers face in emerging markets with The Center for Biosimilars^®.

The Center for Biosimilars (CfB): What are some of the most significant challenges to biosimilars in Latin America (Latam) today?

Francisco Ballester (FB): One of the key challenges for biosimilars in Latam is regulatory heterogeneity. The knowledge level concerning biosimilars among key stakeholders—regulatory authorities, payers, and prescribers—varies, and while the region is moving to increase its standards, there are no harmonized regulations, which leads to noncomparable products, or biocopies, entering the market.

Biocopies are creating confusion among prescribers, and current guidance regarding interchangeability and substitution is lacking.

Additionally, low price ranges, especially in smaller markets, make it unattractive for true biosimilar companies to enter the market; there needs to be greater access to biosimilars, as products are still not available to all patients. However, we see huge potential to increase access to biosimilars in the region.

CfB: Do you see copy biologics or local products as a hurdle for biosimilars in the Middle East as well?

FB: Biosimilarity is a proven regulatory concept in highly regulated markets, and the problem with biocopies is that they simply have not demonstrated that they meet those standards.

Biocopies are—not only in the Middle East—a hurdle for true biosimilars due to polarization of the market for perceived high-quality originators versus perceived low-quality biocopies. This fact leads to confusion about differences between biosimilars and biocopies. Lower clinical and data requirements and investments for biocopies allow for earlier approval and lower costs, and this can distort direct competition.

A lack of comparability data with the originator, and the potential for negative clinical outcomes in terms of efficacy and safety, could also harm the reputation of true biosimilars, and with many brands in the market, it is difficult for clinicians, both prescribers and pharmacists, to distinguish which product is the true biosimilar versus a biocopy.

CfB: How do policies related to biosimilars differ in emerging markets versus in the European Union and the United States?

FB: Regulatory authorities and ministries of health have very different knowledge levels regarding biosimilars, leading to heterogeneous policies and incentives for biosimilars across the markets.

Approval requirements, as well as timelines, differ largely from country to country and are still changing, resulting in lower predictability for biosimilar manufacturers. Additionally, outside of Europe, there is a lack of direct prescribing incentives for biosimilars, such as those seen in Germany, beyond pure price competition.

CfB: Have you encountered different attitudes toward biosimilars among prescribers in the Asia—Pacific region than in Europe or the United States?

FB: Due to availability of many biosimilars in the market and greater clinical experience, EU prescribers especially are often ahead of Asia—Pacific prescribers in terms of understanding and openness to using biosimilars.

Asia—Pacific and other non-EU or US prescribers sometimes do not yet understand requirements for EU and US biosimilar approvals and standards, and they can confuse biosimilars with biocopies.

Although awareness and understanding of biosimilars is increasing, significant education and personal experience is still needed in order to catch up with EU prescribers in terms of the knowledge and confidence to prescribe biosimilars.

CfB: What educational needs about biosimilars do you see remaining for prescribers?

FB: Education and training on biosimilars in general is still needed. This includes education about the development of biosimilars, analytical and pharmacokinetic and pharmacodynamic similarity with the reference product, phase 3 confirmatory studies, and therapeutic indications. And, as you may already know, biosimilars, like all biologics, have a natural range of variability.

Other areas include clinical experience with marketed biosimilars from Europe as well as understanding of cost-saving potential, development and manufacturing standards for European Medicines Agency- and FDA-approved biosimilars, the difference between biosimilars and biocopies, and the need for biosimilar prescribing incentives to drive uptake.