Claudia Martínez, generic & biosimilar medicines programme manager at the Access to Medicine Foundation, draws from a recent AMF report to outline what more generics companies can be doing to ensure greater access to their essential products. Martinez argues that for people living in low-and middle-income countries (LMICs), generic and biosimilar medicines can be a vital lifeline – but only if they are within reach.
Frequently, R&D-based pharmaceutical companies are the ones at the centre of conversations about access to medicine in LMICs – especially given the need to rapidly expand access to their innovative, high-profile, and sometimes-pricey treatments. But the truth is that the majority of pharmaceutical products that people living in the world’s poorest nations rely upon are actually generic medicines. In some LMICs, generics make up as much as 80 percent of the market share, making them a vital lifeline for patients in these countries. What’s more, the vast majority of medicines that the World Health Organization deems ‘essential medicines’ have already gone off patent.
This gives generic and biosimilar medicine manufacturers tremendous power when it comes to expanding access. These companies’ decisions about manufacturing, registration, pricing, and supply in LMICs can have a significant impact on whether an essential medicine ultimately becomes available, and whether it is made affordable for the people who need it.
The expiration of patents and the entry of generic and biosimilar manufacturers into the market do not, on their own, guarantee access for all
Generic medicine manufacturers have often been celebrated as the champions of affordable access. As patented medications lose their exclusivity, these companies step up to produce and distribute more affordable versions of brand-name drugs, opening doors to wider access. Look no further than the remarkable progress in access to HIV treatment, where the introduction of generic versions has helped drive down the cost of antiretroviral drugs by more than 99 percent over the last decade. This has made these medicines more accessible to a larger number of people, especially in LMICs.
However, the expiration of patents and the entry of generic and biosimilar manufacturers into the market do not, on their own, guarantee access for all. Many basic, lifesaving medicines – some of which have been off-patent for decades, and many of which can be produced relatively inexpensively – are still out of reach for many, whether that is because they are unaffordable or because they are outright unavailable to the people who need them most.
My team at the Access to Medicine Foundation has recently released a report that sheds light on the current landscape of practices among specific generic players in access, highlights some standout approaches, and pinpoints some of the key areas where companies can make strides forward. The report evaluates the efforts of five market-leading generic and biosimilar medicine manufacturers – Cipla, Hikma, Sun Pharma, Teva and Viatris – in terms of their actions to broaden access to essential medicines within their portfolios. From this analysis, some intriguing findings emerged, as well as clear opportunities that companies can now seize.
The evolving role of generic and biosimilar medicine manufacturers in access
For decades, the power and potential of some of the largest generic medicine manufacturers has been grossly underestimated. While we may commonly associate them with producing affordable off-patent medicines on a massive scale, their contributions extend far beyond this. The COVID-19 crisis highlighted this fact, as manufacturers swiftly ramped up production to meet the demand for essential treatments. These companies also partnered with Big Pharma through non-exclusive voluntary licensing agreements, leveraging their established presence in LMICs to increase and sustain the supply chain.
Generic medicine manufacturers also have a significant impact on the supply of Active Pharmaceutical Ingredients (APIs), which are vital building blocks in the manufacturing of medications. They supply APIs not only to other generic manufacturers but also to Big Pharma companies globally. Cipla, for instance, supplies APIs to over 50 countries while Sun Pharma serves more than 60 countries. This demonstrates the vast global reach of these companies, and the fact that generic manufacturers are not only responsible for producing off-patent drugs but also play a pivotal role in manufacturing many innovative products.
For decades, the power and potential of some of the largest generic medicine manufacturers has been grossly underestimated
In addition, a significant shift is occurring within the generic landscape itself. Many leading players in the industry are diversifying their product portfolios, branching into branded generics, and launching high-margin specialty products in areas such as respiratory diseases, cardiology, and dermatology. In many cases, the shift has also been accompanied by an intensified focus on high-income markets, particularly the United States. As patents for blockbuster biologic treatments expire, such as those for cancer and immunology treatments, biosimilars are also emerging as a new opportunity.
The investor community is also paying attention and responsible investors now expect companies to not only develop sustainable business models and generate profits but also to embed models that prioritise affordable healthcare access for the most vulnerable.
Amidst this transformation, it is crucial for companies to maintain their commitment to ensuring affordable access to vital treatments, including for people living in LMICs. By withdrawing from these markets or shifting focus solely to more lucrative markets, manufacturers risk not only shortages but also failing to uphold their pledge of affordable access for patients in need. Yet, this isn’t a challenge companies can tackle in isolation. Action from other players is also necessary to address some of the challenges that push manufacturers to withdraw from these markets in the first place. New pricing strategies to enable low-cost generic producers to secure reasonable profits and more streamlined regulatory frameworks will help here.
What opportunities are there for companies to tap into?
The generics industry can certainly do more now to ensure that their products are entering LMIC markets. Filing for registration with national regulatory authorities (NRAs) is a key step to make products available to patients locally. This process also acts as a gatekeeper, ensuring that the products meet stringent safety, efficacy, and quality standards. Moreover, when multiple players register and enter these markets, it stimulates healthy competition, which, in turn, helps drive down prices. This is where the real benefit for patients starts to materialise.
When products aren’t registered or their registration expires without renewal, it can lead to shortages, leaving patients in a vulnerable position. Worse yet, it can open the door for substandard or falsified medicines to infiltrate the market, jeopardising public health. There can be challenges around registration; in many LMICs, lack of capacity within NRAs to process dossiers and lengthy approval processes can stifle competition but also discourage companies from even entering in these markets.
Encouragingly, these five companies have a proven track record: our analysis found that, collectively, they’ve successfully registered products in over 80 percent of the 108 LMICs in scope. They can build on this by utilising their experience navigating the regulatory landscape in these countries to get more products available.
These registration practices should not be confined to the off-patent generics they manufacture; it should also extend to those they manufacture through licensing agreements with R&D-based pharma companies. The key to making these partnerships work isn’t just about Big Pharma being willing to license out their products and generic companies being ready to step in. It’s also about their commitment to following through on the terms of these agreements. That means ensuring that these products get registered in the countries covered by the agreements so they can be manufactured and supplied to those who need them the most. Furthermore, several mechanisms have been put in place to facilitate national authorities’ assessments and speed up the regulatory process, many of which companies are not yet fully tapping into.
In addition to registering products more widely, the generics industry has a chance to ensure better availability of products, especially at the local level. Some of the companies analysed in the report are already making strides in this space, specifically by investing in making their supply chains more resilient and taking steps to diversify their suppliers.
To play a more active role in bolstering local production, companies have the opportunity to explore new approaches, whether independently or through partnerships. This could involve strengthening their manufacturing presence in LMICs or partnering up with local players to expand production capacity. Such actions could not only widen the pool of producers but also reduce the heavy reliance on imports and provide quicker access to medicines when a crisis strikes. This holds significant value for Africa, where up to 70 percent of pharmaceutical products are imported and only 20 countries on the continent currently have production capacity: In Angola, Benin and Gabon, for example, only one manufacturer is present, respectively, meaning that these countries almost solely rely on imports.
Large generics companies – as well as R&D-based pharma companies – have shown some interest in growing their manufacturing capacities within the African continent or are finding ways to use their existing capacity to bring products to African markets.
The harsh reality remains that lack of affordability is a significant barrier to equitable access to essential medicines, even for those long off patent
For instance, Hikma has worked to build up its manufacturing capabilities to produce APIs for cancer drugs, which has allowed them to provide life-saving medications to other countries in the Middle East and North Africa at a lower cost. Viatris has established packaging and distribution facilities in Zambia, helping build local capacity and making HIV treatments manufactured in India locally accessible. Cipla, as one of the three sub-licensees for the recently announced non-exclusive licensing agreement with ViiV Healthcare – brokered by the Medicines Patent Pool – is planning to manufacture the generic version of ViiV’s cabotegravir, the first long-acting HIV prevention medicine, in its plants located in South Africa.
Such actions can yield a dual benefit. They not only improve the reach and availability of products in LMICs but also help companies sustainably expand business in these countries.
All this said, the harsh reality remains that lack of affordability is a significant barrier to equitable access to essential medicines, even for those long off patent. The fact that a medicine is lower in cost does not necessarily mean that it will be affordable to those living in LMICs.
Consider, for example, that among the top 20 medicines considered critically important by oncologists in LMICs, a staggering 70 percent are older drugs, many of which are already available in generic form. Yet, in many cases, these vital medications continue to be prohibitively expensive, leaving patients vulnerable to catastrophic healthcare costs. What’s more, in many LMICs, the burden of purchasing medicines often falls on the shoulders of patients themselves. Take Sub-Saharan Africa, for instance, where 40 percent of the population lives below the poverty line, lacks any form of health insurance coverage and must turn to private pharmacies and drugs stores to get their medicines. In Nigeria, 90 percent of people find themselves grappling with the weight of out-of-pocket payments for medicines.
It is important that companies continue to engage in public sector tenders and participate in available pooled procurement initiatives. This remains a critical strategy to increase the availability of quality-assured products and ensure that medicines are priced within the reach of countries and their populations.
But, in an evolving landscape, companies must also think beyond the traditional tender model and refine their strategies to ensure broader access, especially for people without insurance or those reliant on out-of-pocket payments. A critical step here is to develop a deeper understanding of the affordable price point that enables accessibility for different types of products, within specific LMIC markets. Another promising approach, which has been tried and tested by some R&D-based pharma companies already, is to collaborate with local organisations, patient organisations, or not-for-profits, to support the access and affordability challenges faced by these patients. Viatris, for instance, has a patient assistance programme, ‘Ashray’, in India for the cancer medicine bevacizumab (now transferred to Biocon Biologics). This programme provides free drug support to low-income patients, including those without private or public insurance who bear the full cost of their treatment.
There is still so much that generic and biosimilar manufacturers can do in order to improve access. Clearly, a concerted effort and action from all stakeholders across the private and public sectors is needed to streamline procurement, enhance regulation harmonisation, and collaborate on new financing models. However, at its core, it is the generics industry that is often in the driver’s seat, steering in the right direction when it comes to supplying the essential medicines upon which billions of people in LMICs depend.