Era of biosimilar drugs – what impact for people with arthritis?

With patents for some key arthritis drugs reaching the end of their lifespan, biosimilars – biological medicine made to be similar to an existing biological medicine – will be used more widely as a cheaper option for the NHS. But what does this actually mean for people with rheumatoid arthritis and ankylosing spondylitis.
The British Society for Rheumatology (BSR) says that it is good news. The drugs have been manufactured to have no meaningful differences from the original drug in terms of quality, safety or efficacy, and have been through rigorous tests. But the BSR highlights that measures need to be in place to monitor their safety and efficacy in order to provide patients and healthcare professionals with suitable assurances.
The first biosimilars for rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis will be introduced to the UK this month. Although these drugs have undergone stringent testing, the experts from the BSR outline that there are gaps in the evidence base on their safety and efficacy, largely because they haven’t yet been in use for lengthy periods of time.
“And also because we don’t have data on people switching between drugs yet,” says Dr Alan Roach from the BSR. “But the BSR and other groups across Europe are collecting this information.
“We recommend that every patient is involved in the decision making process. However there are also pressures on the NHS to save money.”
Prof Alex MacGregor, chair of BSR Biologics Registers comments:
“Widening the range of treatments available to our patients at a lower cost to the NHS is clearly a positive step, but there are still a few gaps in the evidence for the safety and efficacy of these products, which will need to be explored further. For example, the clinical trials of these drugs for people of rheumatological or autoimmune diseases were with new users only, and no trials have explored the effects of substitution from a reference drug. We urge our members to be open and clear with patients about their choices in treatment and to focus on their clinical needs when prescribing.”
Two registers of patients receiving biological treatments have been set up, which monitor the long-term safety of biologics drugs and provide valuable information about their effects in long-term use:
• The BSR Rheumatoid Arthritis Register
• The BSR Ankylosing Spondylitis Register
“This increases our understanding of these drugs and how best to use them for patient benefit,” Dr Roach explains. “The registers track the progress of patients with rheumatoid arthritis or ankylosing spondylitis by recruiting patients prescribed to the specific biologics drugs we are recruiting and then following them, collecting information on patient health and treatment at regular intervals.”
If you’d like to join the register, ask your consultant if it’s possible.

For more information on the registers click here.

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Image credit: Yinan Chen