The inaugural report from the Access to Medicine Foundation’s Generic & Biosimilar Medicines Programme takes an in-depth look at what five major industry players are doing to expand access to their products in low- and middle-income countries (LMICs).
The report marks the first time that any generic or biosimilar medicine manufacturers have been assessed in-depth on their access-to-medicine efforts. This first iteration profiles Cipla, Hikma, Sun Pharma, Teva, and Viatris, analysing their engagement in access and highlighting opportunities to address gaps in affordable and reliable access to the quality-assured essential medicines produced by these companies.
Generic and biosimilar medicines can serve as lifelines to millions. Of the medicines classed as “essential” by the World Health Organization (WHO), 90percent are off-patent, including treatments for cancers, heart disease, epilepsy, diabetes, maternal hemorrhage, bacterial infection, tuberculosis, malaria and HIV.
Once a patent for a medicine expires, other drug manufacturers are free to develop a generic or biosimilar version and enter the market, potentially introducing competition and increasing supply. Not only do generics and biosimilars offer the same therapeutic and clinical benefits as the originator medicines, but they are often supplied at a much lower cost. Some of these companies now also manufacture generic or biosimilar versions of patented products under voluntary licensing agreements, which can expand and accelerate access to innovative medicines worldwide.
However, generic and biosimilar products are still out of reach for many patients in LMICs, especially those living in low-income countries and those from vulnerable populations. Even if a product is comparatively cheaper, payers may still not be able to afford it – including healthcare authorities in LMICs, as well as individuals who rely on paying out of pocket for their healthcare – and there are also significant availability issues. The world’s leading producers of generic and biosimilar medicines occupy a central position in the global health landscape, and they can use this to expand access to essential medicines.
“When it comes to expanding access to medicine, the power of the generics industry is often underestimated. It’s more than the transactional relationship of selling drugs at volume and competing on price. Companies must engage with the unmet medical need globally – for example, by working with local manufacturers to improve supply, by taking steps to safeguard quality, by
making their essential products available in more countries, and by addressing affordability for the poorest patients.” – Jayasree K Iyer, Chief Executive Officer, Access to Medicine Foundation.
Using the Analytical Framework, a first-of-its-kind assessment tool developed by the Foundation’s newly established Generic & Biosimilar Medicines Programme, this data-driven analysis zooms in on the actions of five companies chosen for their size, influence and involvement in global health: Cipla, Hikma, Sun Pharma, Teva and Viatris. Collectively, these five companies have a wide portfolio of essential medicines and a well-established presence in LMICs.
“For the very first time, we’re shining a spotlight on the actions, efforts, and commitments of leading generic and biosimilar medicine manufacturers to broaden access to lifesaving medicines in LMICs. Although there are standout examples of action, clear opportunities also exist for companies to ramp up their efforts and to work closely with local implementers, governments, and global health organisations to continue to break down barriers for the millions who either lack adequate access or are forced to go without the medicines they need.’ – Claudia Martínez, Research Programme Manager, Generic & Biosimilar Medicines Programme
What did the report find?
• Companies have a collectively broad regulatory footprint in LMICs, yet many essential products are not widely registered
• Companies are using access strategies to expand access to their products in LMICs, yet efforts fall short for the poorest patients
• Despite initiatives to strengthen manufacturing, further efforts needed to safeguard product availability
• Companies are engaging in adaptive R&D, tailoring products to the needs of people in LMICs
