Patient Access, Cost Inhibit Adoption of Biosimilars in Poorer Global Markets

Fear of biosimilars, drugs that once launched will potentially capture entire markets with their discounted prices, is not likely to be an issue in some of the poorer countries in Asia and Latin America, where even cheaper biosimilars are too expensive for the general public. With numerous patient access challenges, biosimilars have had a difficult time finding their footing in some of these markets.

“All these projections of $20 billion, $10 billion, loss of exclusivity by 2020, prices going down 50 percent, it doesn’t happen in reality,” Sreedhar Sagi, head of medical affairs Asia-Pacific at Sandoz, a Novartis company, told BioWorld Today.

More developed markets, most notably New Zealand, have developed policies that ensure patient access, but not access to the market to biotech companies. New Zealand has a tender system in place, with a single drug in each category allowed for sale in the country that takes all pricing issues out of play while guaranteeing sales for the successful companies that get something of a monopoly for a time. Not every biosimilar maker can enter the market; they have to have regulatory approvals and established markets elsewhere. Because the government chooses one drug for the entire country, there are no marketing or significant sales costs.

“New Zealand has a very price-driven policy,” said Sagi. “The money can be shifted to real need rather than buying biologics that are years old,” Sagi said. “The doctors have only one choice of each biosimilar; it’s one drug, one company and the doctor has to use it.”

Sandoz is the generic pharmaceuticals division of Novartis and has marketed three biosimilars – a human growth hormone, G-CSF and epoetin alfa – that account for more than half of combined biosimilar sales in North America, Europe, Japan and Australia. It also has a pipeline of biosimilar molecules under development and registration including biosimilar rituximab and etanercept.

Like New Zealand, Malaysia also has a general tendering system but different policies. Because there are multiple players for a single product, companies have to fight for prescriptions. Adding sales and marketing costs results in higher prices.

Sagi said the New Zealand approach is a good one for countries with a relatively small population and high income. New biologics can cost patients tens of thousands of dollars per year, said Sagi.

BIOSIMILAR COPIES EMERGE

For countries where most of the people can’t even afford biosimilars, a new type of product that Sagi calls “a third type of product” is emerging.

“There are copies of biosimilars manufactured in different countries in Asia and Latin American, which are far cheaper.”

These products are not U.S. FDA- or EMA-approved “true biosimilars” but biologics that should have the same effect but are without clinical studies.

“The [World Health Organization] is even considering a third type of product that could be used in [low income] countries such as Laos, Cambodia, Vietnam, Chile and Peru, that don’t have the economies or scales to afford the [U.S. and EU] approved biosimilars,” he said.

The true biosimilars, even when they’re already cheaper than originator drugs, still require plenty of clinical studies to prove biosimilarity. And that’s adding up to the prices at the end.

“The clinical studies are where the cost goes up,” he said. “For the third-wave products you need to show from an analytical point of view that they’re the same molecules, probably PK [pharmacokinetic] or PD [pharmacodynamics] studies, then you get the license,” he added. “If you can really prove your molecule is as close as the originator can be in each batch then there should be no problem.”

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This article was co-authored by Cornelia Zou and Alfred Romann.

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