Biosimilars Gaining in Popularity for Rheumatoid Arthritis

Maureen Salamon

June 14, 2019

MADRID — The push by rheumatologists to switch patients with rheumatoid arthritis from biologics to biosimilars will likely gain momentum in the coming year, fueled by potential cost savings, an expert predicted here at the European League Against Rheumatism 2019 Congress.

"Very substantial cost savings are possible despite the high costs of biosimilar development. We all know that's very important," said Gerd Burmester, MD, from Charité University Medicine Berlin.

And "the many trials done have shown there's a lack of impact from switching from a reference product to a biosimilar on efficacy, and emerging real-world experiences are important here," he told about 2000 audience members.

"I personally believe switching should involve intense discussion with patients and, ideally, will be based on a shared decision," he said.

In rheumatology, biosimilars such as adalimumab, etanercept, infliximab, and rituximab have been approved by the US Food and Drug Administration, the European Medicines Agency, and other international regulatory agencies.

But, "there's been a lot of debate regarding their interchangeability," Burmester said. "It's handled differently from country to country."

In 2016, it was estimated that biosimilars could generate savings of more than $100 million by 2020 in the five most populous countries in the European Union — France, Germany, Italy, Spain, and the United Kingdom — plus the United States.

And a recent move by the government of British Columbia in Canada to switch more than 20,000 patients to biosimilars will save an estimated $72 million over 3 years.

Cost Saving

"This is a very exciting development," Burmester said, adding that new options for rheumatoid arthritis are clearly needed.

"Only a maximum of 50% of patients achieve a complete remission, so there's still a high demand for new therapeutics," he reported.

Burmester presented an evolutionary overview of rheumatoid arthritis treatments, noting that biologics, such as adalimumab and rituximab, became prominent in the early 2000s, a decade after disease-modifying anti-rheumatic drugs (DMARDs), such as cyclosporine and methotrexate, entered the market.

The development several years later of small-molecule drugs — such as the Janus kinase (JAK) inhibitors tofacitinib (Xeljanz, Pfizer) and baricitinib (Olumiant, Eli Lilly) — which are often combined with methotrexate, offer patients additional benefits, including oral administration instead of injection and a strong safety profile. Additional JAK inhibitors are in development.

Data on biosimilars are recent, but studies are indicating little if any difference in efficacy, making them far more likely to hit the mainstream in rheumatoid arthritis treatment in coming years, Burmester said.

In comparison trials, "it can be very difficult to discriminate which is the original product and which is a biosimilar because the data are exactly the same," he explained.

"A number of practical questions regarding the use of biosimilars remain," he pointed out. "How many drugs can a rheumatologist memorize? And how can the nocebo effect be avoided when patients realize they are not getting their trusted drug anymore? That needs to be taken into account."

But, in general, patients seem satisfied with having many therapeutic choices, said Eni Pereira Berci Pinho, MD, from Catholic University of Brazil in Taguatinga.

"I've had good experience with biologics," Pinho told Medscape Medical News.

But an increasing focus on biosimilars — in part because of a government push to reduce healthcare costs — is warranted. "Everyone has to be treated but we have only a limited amount of money," she said.

Burmester is a consultant and member of the speakers bureau for Roche and Sanofi-Genzyme. Pinho has disclosed no relevant financial relationships.

European League Against Rheumatism (EULAR) 2019 Congress. Presented June 14, 2019.

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