Webinar: Aligning Biosimilar Access Policy With Global Health Priorities

Health care systems around the world are facing increasing challenges—from rising costs to gaps in access. Biosimilar medicines offer a promising solution, helping make care more accessible, affordable, and sustainable for patients everywhere. These goals align closely with the United Nations’ Sustainable Development Goals for Health by 2030, and today’s discussion will explore how biosimilars can help make that vision a reality.

This webinar is part of the sixth Annual Global Biosimilars Week, running from November 3 to 7, 2025. The theme this year—“Biosimilars: A Wise Investment for Global Health”—perfectly captures the spirit of this conversation and the opportunities ahead.

Speakers (in order of appearance)

• Skylar Jeremias, managing editor of The American Journal of Managed Care^® and The Center for Biosimilars^® (host)
• Julie Maréchal-Jamil, senior director of biosimilar policy and science at Medicines for Europe (moderator)
• Helen McGuire, global lead, Non-Communicable Diseases, PATH Coalition
• Navin Kumar Loganadan, clinical pharmacist (Endocrine/Diabetes) at the Endocrine Institute at Hospital Putrajaya in Malaysia
• Socorro Márquez, director of regulatory affairs at Sandoz Mexico
• Aurelio Arias, director of thought leadership at IQVIA
• Paul Cornes, MD, oncologist at the University Hospital Bristol NHS Foundation Trust in the UK
• Lisa Hedman, senior advisor in the Division of Access To Medicines and Health Products (MHP) for the World Health Organization (not shown)

Answers From the Live Audience Q&A

These were questions asked by the audience during the live broadcast of the webinar. The speakers provided responses after the webinar ended. Below are their responses and insights.

Are there examples of biosimilar-driven access improvements that could be replicated in other regions?

Julie Maréchal-Jamil: There are examples available in the IGBA Biosimilar Access Policy Blueprint (2021) as well as in IGBA Biosimilar Communication Resources (Module 5 - The benefits of biosimilar medicines). Translating the biosimilar availability opportunity into tangible access development is always a matter of policy framework and policy interventions that transform the cost-effectiveness gains into investment in better use of resources and more efficient processes.

The 2024 NCD Best Buys report aims at supporting WHO member states to prioritize and scale up the implementation of the most impactful and feasible interventions in the national context. Off-patent medicines, including biosimilar medicines, are part of the best buys. Could you tell us more about the overall progress so far to meet the 2030 goals? (Are we on course? Are we delayed?)

Lisa Hedman: The target established by WHO is for 80% availability. While there has been movement, it is not even across all regions and also varies between the private and public sectors, with private sector availability being slightly higher. The ranges are 38-68% in the public sector and 42% to 77% in the private sector. Some of the challenges are high prices, where many countries pay higher amounts than the international reference price, including both acute and chronic conditions, and where also there is increasing dependency on out-of-pocket payments.

In Mexico, will the government be adopting a streamlined biosimilar development pathway that removes the requirement for phase 3 (comparative efficacy) studies?

Márquez: Currently the requirements by the local rules include the requirement for clinical trials to demonstrate efficacy and safety. In Mexico, the biosimilars are called biocomparables. Below there is more detail about it.

In my experience, the requirements related to clinical trials are case-by-case; in the end, the opinion of the New Molecules Committee and Biotech Products Evaluation Subcommittee (NMC/BPES) will determine the specific requirements for approval of each biocomparable biotechnological medicine. This opinion is based on the documentation presented in the CTD modules 2, 3, 4, and 5. During my presentation, I also mentioned that for biosimilars, the presubmission meeting before NMC/BPES is mandatory.

For biosimilars, below I have described some preclinical and clinical requirements indicated in the local rules, but this can be extended case by case:

• “...The application must include the documentation outlined in Sections I to IX of Article 177, as well as preclinical and clinical studies such as:
  • Biocomparability studies
  • Immunogenicity studies
  • Adverse event reports
  • Any other studies determined by the Ministry, based on the opinion of the New Molecules Committee.”...
• “...III. Reports of preclinical studies in animals must include comparative data between the reference biotechnological medicine and the biocomparable product. These studies must be conducted in relevant animal species and include, as determined by the New Molecules Committee:
  • Comparative pharmacokinetic study reports, when required by the Ministry, to demonstrate pharmacokinetic biocomparability between the biocomparable and reference products, based on key parameters.”...

How many biosimilar products have been approved through reliance pathways in Mexico so far?

Márquez: This data is not available. However, in my presentation I mentioned that during almost 4 years the reliance applied to participate in tenders without MA issued by COFEPRIS, applicable only for tenders to supply public institutions Therefore, some products that participated with MA issued by recognized authorities could be identified during the tender processes (small molecules and biosimilars), but there is no official data about the total number of biosimilar products approved through reliance pathways.

In the future, probably based on the last publication in July 2025, for the application of the abbreviated regulatory pathway (equivalence agreements), the approvals might be differentiated.

Regulatory convergence is improving among EMA, FDA, and WHO, but not all dossiers will meet these new standards.Will companies need to conduct new studies, and how might that affect costs or timelines?

Maréchal-Jamil: Back in 2020, we worked on a policy paper entitled “Developing a Regulatory Policy Framework Supporting Biosimilar Competition: The Opportunity for Tailored Clinical Biosimilar Development” where 2 important points were made:

• A global regulators roadmap towards streamlined biosimilar development program should be adopted - maintaining the scientific and regulatory rigor is needed to support approval, and allow for tailored clinical development.
• The role of regulators extends beyond approval to include education for healthcare professionals to understand the analytical science that underpins biosimilarity, ensuring that regulatory approval translates to utilization of biosimilar medicines.

Today, in 2025, both remain cornerstone to harvesting the benefits of streamlined development. The asynchrony of adoption of the new standards will require developers to at best maintain extended developments (including unnecessary studies) or worst to have 2 developments for the different jurisdictions, although this is unlikely to be retained as a viable option. This points to all international regulatory convergence initiatives (eg, ICH, IPRP, ACCESS consortium) as key drivers for access.

A significant evolution of the regulatory requirements in underway in the global regulatory community (so called streamlined clinical development) offering the perspective of biosimilar developments for more biologic medicines. How can the WHO efforts be amplified, notably in promoting harmonisation of standards (through the guidelines and their implementation) or through collaborative or reliance initiative?

Hedman: If anyone is not familiar with the WHO Prequalification of medicines programmes, I would strongly encourage them to spend some time reviewing the resources and information on the Prequalification website as I am personally on the policy side of the Health Systems Division. In the space of collaboration, the Prequalification programme runs the Collaborative Registration Procedure (CRP) for medicines, vaccines and health products that have been prequalified by WHO. The CRP allows for participating regulators to request, with participation of the manufacturer, the reports and information that were submitted to WHO for regulation for use in considering national market authorizations.

In addition, the concept of regulatory reliance is also advancing through the use of a global benchmarking tool, where countries will be able to develop reliance schemes-based products manufactured under the supervision of recognized regulator. WHO also supports the implementation of WHO biosimilars guidelines in Member States. From November 26 to November 28 in Tunis, WHO will host an implementation workshop for regulators from Africa and the Eastern Mediterranean region, where experience and regulatory frameworks for biosimilars are still developing. This initiative is part of WHO’s ongoing work to promote harmonization and strengthen regulatory capacity globally.

How can we maintain industry sustainability if biosimilar medicines prices drop very quickly in multiple regions?

Maréchal-Jamil: Sustainability of the biosimilar business is linked to the overall functioning of the framework: there are many variables. Market competition is an inherent part of the follow-on medicines’ business. The starting points for all biosimilar medicines benefit is to have a multisource market where biosimilar medicines are used, and uptake is significant.
Are African CDC–equivalent agencies considering adding biosimilar medicines into pooled procurement mechanisms?

Maréchal-Jamil: With the creation of the African Medicines Agency and the pilot African Continental Procedure, there are opportunities for biosimilar medicines developers with biosimilar medicines recognized under the Priority Medicinal Products Category 1 of interest besides facilitating national authorization of the products and strengthening the regulators network, this will without any doubt support translation of approvals into actual market uptake.

WHO is investing in good practice sharing for procurement among WHO member states yet, it feels that there remains an awareness gap among procurers, assimilating biosimilar medicines with generic medicines. This can lead to an impossible match between demand and supply. What can be done to bridge this gap?

Hedman: WHO is, as we are speaking today, convening a Forum for procurers to consider priority best practices for the future. Ensuring quality of medicines using procurement as a lever is one area that has already emerged as a priority.

Another one is transparency into markets, which has a benefit for buyers and also for sellers. The more transparent tender information becomes, for example, the more sources the buyer will be able to attract. Sellers also benefit from improved visibility into markets, which we have understood anecdotally is a challenge in the NCD space. Developing pooled procurement mechanisms is also an area that can supply market entry, which is important in the uptake of biosimilar medicines.

It’s great to hear examples of improved access—but why isn’t this type of data more often published in peer-reviewed journals?

Maréchal-Jamil: an interesting example of improved and early access is that of a Dutch Research Team lead by Lizzy De Ridder in the context of the TISKids Study. The study aimed at making better use of the available treatments for children living with inflammatory bowel disease by changing the treatment paradigm and initiate treatment with the biologic therapy (rather than conventional treatment involving enteral nutrition and corticosteroid therapy). The use of first line infliximab therapy led of significant clinical and endoscopic remission for the children involved (ie, improved health outcomes, disease management and quality of life).

Biosimilar manufacturers have published numerous studies demonstrating clinical equivalence, yet there are far fewer publications from health systems showing real-world benefits—such as increased or earlier patient access and how savings are being reinvested into care. How can we encourage more transparency and data sharing from health systems?

Maréchal-Jamil: Regulators have the possibility to publish reviews of pharmacovigilance data on a regular basis. While the absence of ‘unexpected issues’ maybe unattractive for publishers, it has the merit of reinforcing the robustness of the regulatory system, its standards and the compliance to them. In Europe, there have been 2 such reviews supporting the confidence of healthcare professionals and patients.

1. 2013: Traceability of biopharmaceuticals in spontaneous reporting systems: a cross-sectional study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance databases. Drug Saf. 2013 Aug;36(8):617-25. doi: 10.1007/s40264-013-0073-3.
2. 2015: Traceability of biologicals: present challenges in pharmacovigilance Expert Opin Drug Saf. 2015 Jan;14(1):63-72. doi: 10.1517/14740338.2015.972362. Epub 2014 Nov 5.
3. 2019: Identifiability of Biologicals in Adverse Drug Reaction Reports Received From European Clinical Practice doi:10.1002/cpt.1310

The Center for Biosimilars is a media partner for Global Biosimilars Week.