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A London specialist has endorsed a treatment for the most common type of arthritis among children using a newer approach that lowers costs but in using a class of drugs that has been criticized by some doctors and patient advocates.
London rheumatology Dr. Janet Pope, at Western University, says juvenile arthritis whose cause is not known can be safely and effectively treated with one in a newer class of drugs called biosimilars, which are made in living cells in ways that produce similar but not identical medications called biologics.
The new drug, called Erelzi and made by pharma-giant Novartis, was approved in April by Health Canada to reduce the symptoms of moderately to severely juvenile idiopathic arthritis in patients aged 4 to 17 years who have had an inadequate response to antirheumatic drugs, a condition that affects about one in 1,000 children in Canada.
“The EGALITY study has shown that ErelziTM is safe and effective, and switching patients from (the biologic drug) Enbrel to Erelzi can be performed safely without any loss of efficacy,” said Pope, professor of medicine in the Division of Rheumatology, Epidemiology, and Biostatistics at the University of Western Ontario, Schulich School of Medicine, London. “For patients living with debilitating inflammatory arthritis diseases, this is an appropriate time to discuss new treatment and care options.”
According to a report published in 2011 by the Arthritis Alliance of Canada, there are approximately 300,000 people in Canada (0.9 per cent of the Canadian adult population) living with rheumatoid arthritis, a rate expect to double within a generation, says Sandoz, a division of Novartis.
Approximately 50,000 Canadians affected by rheumatic conditions struggle or are unable to dress and groom themselves, walk, wash, or use a toilet. It is estimated that about only 15 per cent of those patients currently have access to biologics.
“Biologics have revolutionized the treatment and prevention of many disabling and life-threatening diseases. However, they are contributing to the rising costs of healthcare, and this may restrict access to these important medicines,” Michel Robidoux, President and General Manager of Sandoz Canada, said . “Unfortunately, as it stands today, not all Canadians living with debilitating disease have the same access to biologics. There is a growing population that has a relatively high prevalence of immunological diseases, such as rheumatoid arthritis. Launching Erelzi is another concrete example of how Sandoz is making access happen by offering high-quality medicines at a more affordable price, which will deliver important savings to healthcare system.”
But not everyone has been supportive of using biosimilars to replace biologics because the process using living cells is so complex that biosimilars aren’t identical to their more costly cousins.
So while conventional brand-name drugs can be replaced by virtually identical generic drugs, the swap of biosimilars for biologics generally has raised concerns for some, including the U.S.-based Alliance for Safe Biologic Medicines. The Alliance doesn’t flatly oppose biologics and notes they can save money in cash-strapped health systems, but says that the interests of patients must be paramount.
What are biologic drugs?
Used for many cancers and chronic conditions, they’re made in living cells and have a much more complex structure than older drugs made using chemicals in labs; costly to create.
How lucrative is the market for biologics?
$155 billion in 2012, with growth of nine per cent a year, according to drug-maker Hospira, including $3 billion in Canada.
What is changing?
Patents for many biologics end in the next five to 10 years, opening up the marketplace to others.
What will fill that marketplace?
Biosimilars, a newer type of drug, also made using living cells and designed to have the same effects as biologics, even though they look different under a microscope. Cheaper to make than biologics, they are called biosimilars because they are similar but not identical to biologics.
Isn’t this just a type of generic drug?
No. Generic drugs exactly duplicate brand-name drugs; you can’t tell them apart under a microscope. A biosimilar is not a replica.
Why should I care?
The first biosimilar was approved in 2015. Drug companies sais then the new drugs could save Canadians $740 million a year by 2021, an attractive pitch to cash-strapped health ministries. But some doctors and patient groups aren’t convinced biosimilars will be effective and say more study is needed.
What has the rest of the world done?
The U.S., like Canada, was slow to adopt biosimilars, while Australia and Europe have been more aggressive.
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