From The Editor | September 26, 2018

Charting A Biosimilar Course In Low- And Middle-Income Nations

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By Anna Rose Welch, Chief Editor, Biosimilar Development

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A few weeks ago, I published an article highlighting the work of The Access to Medicine Foundation (the Foundation), which is best known for its reports on the work pharma companies are doing regarding access to medicine in low- to middle-income countries. The non-profit organization recently published a study on improving access to cancer care in 107 developing countries. As the biosimilar industry continues to approve and establish market access strategies for oncology biosimilars, this report is a great resource to peruse. After all, many of the blockbuster products facing biosimilar competition are critically needed therapies in low- to middle-income countries. I hope those who read the Foundation’s report will be inspired to look into these markets and adapt some of their own strategies based on what innovators are doing.

When I asked the Foundation’s Executive Director, Jayasree K. Iyer, if she had a sense of the work being done by biosimilar companies in these countries, she said more research is needed to quantify that accurately. But we are clearly at a tipping point when it comes to introducing biologics and biosimilars to these nations. For instance, we’ve begun to see the evolution of regulations — one of the most important being the expansion of the WHO’s prequalification process to rituximab and trastuzumab biosimilars. (This is currently in the pilot stage.) Similarly, the pharma industry’s growing investments in infrastructure and capacity development all point toward the fact it’s time for the biosimilar industry to define what “good practice” looks like in these nations.

Iyer also pointed out national governments’ efforts which show more attention being paid to overall accessibility of biologics, especially in the oncology space. “We’re starting to see many countries prioritize cancer care in their universal healthcare coverage,” she said. “Ten years ago, we didn’t have national cancer control plans across sub-Saharan Africa, and now several nations including Kenya and Nigeria have them. This means the governments are saying, ‘We recognize the issue in our country, and we are willing to invest in providing care.’”

Today, many of us — myself included — may have been operating under the assumption that a majority of low- to middle-income countries have little to no infrastructure established to handle biologic medicines. But there are currently biologics being used in the developing world — in particular, vaccines. These biologics vary in terms of ease of use and safety profiles, and there are, of course, nations that will need more attention paid to financing, facility development, and cold chain. Though entering some of these nations will not be for the faint of heart, Iyer believes the solution to these access issues is closer than we realize.

“We just need that human effort to say, ‘Look, there is already a basis, and we will need to invest a lot in building capacity and that infrastructure to administer this product,’” Iyer said. “‘But it’s better to think about the access problem and slowly solve it, rather than counting off the reasons why it shouldn’t be done.’”

Defining A “Strong” Access Strategy In These Nations

There are a number of complexities to consider when approaching low- to middle-income countries. When approaching a low-income country, companies will need to keep in mind that many have no manufacturing capacity or proper logistics established. As such, the supply of biologics to patients in these nations will be a big issue to consider. In situations such as these, companies should be seeking partnerships in a specific disease area with organizations and companies that are knowledgeable about these countries’ infrastructure and treatment needs.  

In a middle-income nation, one of the greatest challenges is the uneven distribution of wealth. If we look at India, as an example, there are many different socioeconomic segments of the population, and each has different needs and abilities to pay for medicines. There are not just two socioeconomic layers — the rich and the poor. As such, companies need to understand the demographics of the healthcare market — for instance, where do the different socioeconomic classes go for treatment? Establishing a sound supply chain and a user-friendly administration method for the product will require knowledge of how these different populations receive and use biologics.

In particular, Iyer pointed out the importance of knowing what kind of facility will be distributing the medicine and how many beds each facility has. For instance, if biologics are being used in specialized cancer hospitals, knowing the capacity and turnover of patients for certain types of cancer will provide a better sense of which treatments are used regularly and are most critical to supply. “Does the hospital see mostly breast cancer patients, and does it have specific protocols and guidelines for treating those patients, or does the hospital treat many different types of cancers and have more general treatment guidelines established?” Iyer added.

As the cancer care report revealed, innovators have established different strategies to bring their medicines into the low- and middle-income markets. But the strongest strategies overall are those that invest in the entire continuum of care and span multiple nations, as opposed to just a few countries as part of a smaller project. “The scale, the scope, and the entirety of the continuum of care are good markers to see whether a company is succeeding,” said Iyer.

There are quite a few services and tasks companies must consider and plan for in the cancer care arena. The Foundation’s cancer care report lists 15 steps in the continuum of care, including patient/caregiver support, education, training healthcare professionals and community workers, screening, and diagnosis. These earlier, foundational steps eventually require distribution, treatment, and, finally, pain management/palliative care.

In order to determine companies’ access efforts and coverage of the treatment continuum, the Foundation analyzed data collected from 20 of the world’s largest research-based pharma companies ranked in the 2016 Access to Medicines Index. From this, they learned that 16 of the world’s largest companies are taking some action to improve access to cancer care. For instance, Roche comes in on the high end with 10-plus initiatives in awareness and education, and five-plus in screening, diagnosis, and pricing. A majority of the companies, however, only boast from one to four initiatives across the spectrum. No surprise here, pricing was the one category of the continuum within which all but three of the companies surveyed had at least one initiative.

Iyer acknowledges that tackling this continuum can be quite daunting and reassures that companies don’t have to do everything. (There are, of course, other stakeholders that have a role to play as well, including governments and regulatory agencies.) But to start out on the right foot, it takes awareness of the challenges within each country for patients to get medicines. In South Africa, for example, citizens are aware that Herceptin and Enbrel are available in their country, but they aren’t able to access them. “That’s where you want the companies responsible for these originators or the many companies working on biosimilars to think about how they can go about solving the problem of access for the majority of South Africans,” she explained.


In an upcoming article, Iyer shares some of the ways biosimilar companies can broaden their market access strategies in low- to middle-income nations. Stay tuned!