Strong examples of adaptive research and development (R&D) projects can be identified, with companies developing products better suited for use in low- and middle-income countries (LMICs), including those specifically developed for paediatric populations.
However, access plans for adaptive R&D projects lack depth, predominantly focusing on registration plans, with limited geographical reach.
Although the traditional business model of generic and biosimilar manufacturers has not focused on new product development, historically several companies have demonstrated R&D capabilities to adapt existing products to address unmet healthcare care needs in LMICs, e.g. new fixed-dose combinations (FDCs) for HIV.
Furthermore, the presence and extensive experience of these companies in LMIC markets offers significant potential for developing and expanding access to these adapted products in LMICs. To ensure the rollout of these medicines rapidly and broadly upon market launch, it is imperative that companies develop comprehensive and wide-reaching access plans in the R&D phase of product development.
What is adaptive R&D? The process of adapting existing medicines via R&D – for example, to create products better suited to the needs of patients and health systems in LMICs. This can include developing new formulations, developing new fixed-dose combinations of existing chemical or biological entities, repurposing an existing product for additional indications, or developing a version of the medicine for a new target age group, e.g., children.
The majority of companies in scope are engaging in adaptive R&D
Four companies reported engaging in adaptive R&D activities and were assessed in this area. In total, companies submitted nine examples of adaptive projects that met the criteria for inclusion in this analysis. These projects involved adapting formulations to improve storage conditions or administration and tailoring products for paediatric populations.
Currently, specific R&D gaps exist for products needed globally to address unmet healthcare needs, particularly concerning diseases most prevalent in LMICs. Therefore, adapting existing products through R&D has the potential to address these gaps and cater to the needs of people living in LMICs, including specific age-groups like children. If a priority R&D gap exists, it signifies a lack of effective or suitable medicines to treat a disease or condition. For instance, there might already be a tablet available on the market, but there is a need to develop a formulation suitable for use in children, such as a flavoured syrup, a dispersible tablet or an alternative smaller dose. Gaps are identified by organisations such as Policy Cures Research, the World Health Organization (WHO), the Global Accelerator for Paediatric formulations (GAP-f) and the Rome Action Plan on Paediatric HIV and Tuberculosis.
Six of the nine projects include adaptations that are addressing priority R&D gaps identified specifically by Policy Cures Research G-FINDER report, which publishes data on R&D investments for diseases of global health importance that disproportionately affect people living in LMICs. Generic and biosimilar medicine manufacturers can continue extending their proven R&D capabilities to further engage in adaptive R&D by focusing on these important gaps.
R&D projects have access plans, but these plans are not yet comprehensive
Planning for access during the R&D phase is essential to ensure widespread availability, accessibility and affordability of medicines once a product has been launched. This includes considering access barriers in LMICs. In the past decade, the Access to Medicine Index noted increased access planning among R&D-based pharmaceutical companies. Now, in this assessment of generic and biosimilar medicine manufacturers, the Access to Medicine Foundation examines whether and how this group of companies are engaging in access planning for their late-stage adaptive R&D projects, so that their products reach the people who need them once launched.
All eight late-stage (i.e., Phase II and beyond) adaptive R&D projects in scope are supported by access plans, and there is room for those plans to be strengthened.
Currently, most of the companies’ access plans include intentions to file their product for registration in at least one LMIC. However, half of the access plans submitted by companies do not specify the LMICs in which they intend to register, and the more detailed plans only cover one to two countries.
Furthermore, while product registration is a necessary first step to ensuring product availability, it is equally important for companies to address other access barriers by including additional elements within their access plans to ensure affordability and supply. Few of the plans submitted by companies incorporate considerations such as supply and demand planning, applications for WHO prequalification (PQ), and the development of equitable pricing strategies.
Out of the eight projects, two were developed in collaboration with access-oriented organisations, such as the Drugs for Neglected Diseases Initiative (DNDi). These partnerships can play a crucial role in both developing products adapted to the needs of people in LMICs and ensuring the implementation of access planning that prioritises equitable and affordable access during the drug development process. Generally, access plans developed with access-oriented organisations were found to be more comprehensive than those developed in-house by companies and were the only access plans assessed that included WHO PQ or equitable pricing plans during the product development phase.
Generic and biosimilar medicine manufacturers have shown that they have the capability to engage in adaptive R&D, effectively targeting both priority R&D gaps, as well as the specific needs of patients living in LMICs. Adaptive R&D, by its nature, strives to tailor innovations to suit the needs of patients, including those living in LMIC contexts and climates. However, without access planning to ensure the widespread availability, accessibility and affordability of these essential medicines once they do reach the market, those who require them most may not gain access to the product – despite it being tailored to their needs.
What needs to happen next?
Companies can utilise their expertise and proven capabilities in adaptive R&D to further engage in developing products that specifically cater to the needs of people living in LMICs.
In doing so, they can strategically target existing product gaps. This analysis shows that companies in scope are already actively engaging in R&D projects to address several of these priority gaps. However, there are still many remaining R&D gaps related to diseases prevalent in LMICs and/or formulations suitable for specific patient populations (e.g., children and pregnant people) who currently lack suitable treatment options.
One effective approach to achieving this is by establishing partnerships with product development partners. For example, WHO’s GAP-f has identified strategic business relationships with generic manufacturers as an opportunity to enable accelerated product development of paediatric formulations of priority drugs.
Additionally, planning for access during R&D is crucial to ensure widespread and rapid availability of these adapted products in LMICs when they are launched on the market. Companies can further enhance their efforts by creating more comprehensive access plans that include provisions for timely access in LMICs post-launch, such as registration planning, equitable pricing plans, WHO PQ and supply and demand plans. Companies can also expand the scope of their access plans to encompass a broader range of LMICs to ensure widespread availability.