Biotherapeutics such as recombinant proteins and monoclonal antibodies (mAbs) have become mainstays in the treatment and prevention of many diseases. The proportion of biotherapeutics among new drug approvals has significantly increased in recent years, as has the number of biotherapeutics included on the WHO Essential Medicines List. See latest report HERE.
However, a combination of health system challenges, higher prices and barriers to market entry have hindered broad access to biotherapeutics, especially in low- and middle-income countries (LMICs). As these new, more complex technologies emerge that can have a significant impact on public health, it is important that suitable approaches to support affordable access in LMICs are developed.
MPP’s Mandate Grows Following WHO and Feasibility Study Recommendations
In 2019, the report of the WHO Expert Committee on the Selection and Use of Essential Medicines noted that “in the case of cancer, it would be important that the MPP also explore the application of its model to biotherapeutics so as to facilitate early entry of biosimilars through voluntary licensing agreements in LMICs.” Following this recommendation, between 2019 and 2021, MPP undertook a feasibility study to explore the possibility of expanding its licensing model to biotherapeutics.
The analysis highlighted some of the possible challenges of working on biotherapeutics, including the significantly higher costs and longer timelines for developing biosimilars compared to small molecules, as well as the potential importance of technology transfer. The study also highlighted the critical public health need, the increasing interest from governments and other stakeholders, and the possible opportunities for improving affordability and access by adapting MPP’s model to biotherapeutics. This assessment has been published as a peer-reviewed scientific article in The Lancet Global Health, and in November 2021, the MPP Board decided to expand MPP’s mandate to include biotherapeutics.
MPP Stands Ready to Contribute to the Biotherapeutics Space
MPP is now actively working on bringing more affordable, equitable, and sustainable access to biotherapeutics in LMICs through voluntary licensing and technology transfer. This work is complemented by a new MPP workstream dedicated to Technology Transfer, which is currently overseeing, together with WHO, the implementation of the mRNA Technology Transfer Programme.
In addition, and drawing from the feasibility study, MPP has also adapted its Prioritisation Framework to identify biotherapeutics that could meet critical public health needs in LMICs. Our prioritisation list now includes several biotherapeutics across a number of disease areas that we consider particularly salient from a public health perspective. These include cancer management, with a particular focus on immuno-oncology medicines that have demonstrated compelling efficacy across a variety of settings, such as diabetes, cardiovascular and metabolic disorders, and infectious diseases like HIV and respiratory syncytial virus (RSV).
MPP now stands ready to contribute to the biotherapeutics space. This will include collaboration with stakeholders such as future Unitaid grantees, pharmaceutical and biotech companies, and universities to establish viable business models for access to mAbs in LMICs.[1]
[1] Unitaid’s call for proposals to establish viable business models for access to monoclonal antibodies in LMICs
