From The Editor | September 28, 2018

Off The Beaten Path: 3 Strategies For Improving World-Wide Biosimilar Access

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By Anna Rose Welch, Chief Editor, Biosimilar Development

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I was recently introduced to the Access to Medicine Foundation (the Foundation) and its reports analyzing the efforts of the world’s leading research-based pharma companies to increase access to medicine in low- and middle-income countries. In earlier articles, I introduced the Foundation’s study entitled Improving Access to Cancer Care: The First Analysis Of Pharmaceutical Company Actions In Low- And Middle-Income Countries. This study presented a thorough picture of innovators’ many market access strategies for several leading cancer treatments facing biosimilar competition. I also spoke with the Foundation’s Executive Director, Jayasree K. Iyer, to discuss how biosimilar companies can better reach these nations. As a previous article based on this conversation revealed, low-and middle-income nations naturally demand different approaches, and, there is, of course, still much work to be done to bolster biologics use in these countries. This article continues that discussion, illuminating several specific strategies companies can explore to better reach a wide variety of countries and patients.

What Can Biosimilar Companies Do To Broaden Their Market Strategies?

Back in April, Iyer presented at the Medicines for Europe Biosimilar Medicines Conference in London. And in the months since then, the regulatory space has been aflutter with conversations on what can be done to make the EU and FDA pathways more efficient. What is often not discussed, however, are the pathways in the developing world. In many cases, there is little information about the pathways in the low- to middle-income nations, nor is there great understanding of the mechanisms that support the availability of biosimilars. Regardless, Iyer emphasizes the fact that the presence of biologics in these countries means the pathways exist. “My encouragement to companies is to look for those enabling conditions or co-invest in enabling these conditions,” she said. There are three specific ways she sees this being accomplished.

One of the options that will be available at some point is the WHO’s prequalification process. At this point, the program is still in the pilot phase, but, in the long run, this will be a critical step for companies to expand access to quality biologics. Several countries have had biologics or “biosimilars” for years. But some of the so-called “biosimilars” approved in these markets did not go through as rigorous a development process as those in the U.S. and EU. (In these cases, it’s best to call these products “similar biologics.”) Hence the importance of the prequalification process for a number of markets that either have a less-stringent pathway for biologics development, or no pathway at all. Not only can this process expand access to quality biosimilars, but Iyer argued, “The process also gives manufacturers a stamp of quality from the WHO, which means the product can be distributed widely and used confidently among a variety of national systems.” Indeed, prequalification makes a quality biosimilar available for pool procurement systems and/or multiple government tenders. 

Another strategy is to invest in manufacturing-capacity building. This may seem particularly daunting because of preconceived notions about the supply chain that exists — or doesn’t exist — within low- and middle-income nations. “People still believe — and it is true in some countries but not all — that the health system is weak and supply chains are a huge burden,” Iyer said. One way of ensuring a strong supply chain is to forge a partnership with a local company, as this reduces the production costs and makes the supply chain more secure. Iyer pointed to the partnership between Cipla Biotech and Dube Tradeport in South Africa, in which the two have teamed up to build a facility. The less reliance you have on one facility, the stronger your supply chain will be.

Outside of establishing a local manufacturing facility, licensing agreements are also a good strategy. One such arrangement Iyer pointed to is the global partnership between Novartis and Biocon to develop immunology and oncology biosimilars. In this partnership, Novartis will control the North American market, and Biocon will commercialize the products worldwide. The Indian company will use its low-cost, high-volume model, which Iyer explains will be a helpful strategy to bring biosimilars to a wide array of markets.

In fact, when I asked her what would need to change to ensure biosimilars become more widespread in low- to middle-income countries, she said it takes a conscious effort to build partnerships like those between Novartis and Biocon and Cipla Biotech and Dube Tradeport to solve a specific problem. But it will also need to include educational efforts for all the main stakeholders, with a special emphasis directed toward the governments. “You need to tell people there is something available to help alleviate diseases,” Iyer added.

There have been several examples in low- to middle-income nations that reveal how well things can work with a little investment. For instance, in sub-Saharan Africa and the Middle East, there are clinical data registries associated with controlled environments in which randomized clinical trials are held. Iyer has also heard reports of registries in Morocco and South Africa.

She acknowledged that these registries are associated with controlled environments, as opposed to daily clinical practice. Therefore, it’s impossible to claim that what happens within these controlled environments reflects what happens in the “real world.” Industry investments in capacity building and infrastructure development would be one way to begin seeing advancements in daily medical practice.

We are in a golden age for the development of quality biologics and immunotherapies. But a key part of that innovation is making those treatments available to all the patients who need them, regardless of the market. This leads us to an important, if not uncomfortable line of questioning: “If we can’t make sure the people who need these medicines around the world have them, then can we honestly call ourselves an innovative society?” Iyer asked.