Biologics and biosimilars are similar in effectiveness and safety, but the latter is more affordable as it need not spend on extensive R&D like the original biologics. — StarGraphics
Living with an incurable chronic disease often means relying on lifelong medication to keep the condition under control.
For some conditions, biologics are the most effective treatment.
Biologics are large, complex medicines made from living cells, such as human, animal or plant cells.
However, the large investment that goes into the research and development (R&D) for these drugs, as well as their complex manufacturing processes, makes them costly.
Meanwhile, biosimilars are biological drugs that are able to act as effectively and as safely as the original biologic medication they are based on.
They can be produced by other pharmaceutical manufacturers once the patent for the original biologic has expired.
As biosimilars do not require the long and expensive R&D investment an original biologic does, it can be sold at a more affordable price.
Both biologics and biosimilars are used to treat conditions such as anaemia, certain cancers, inflammatory bowel disease (IBD), psoriasis, rheumatoid arthritis, and other autoimmune or chronic inflammatory diseases.
Sandoz Asia Cluster Medical lead Dr Abdul Mueed Khan explains that biologics are life-changing, yet many patients still have limited access due to their high cost.
“In Malaysia, only 0.21% – not even 1% – of patients currently have access to biologics.
“Biologics are highly effective, but many patients cannot benefit from them,” he says.
“This is where biosimilars play a crucial role, offering more affordable treatments, especially in lower- and middle- income countries where disease burden is high and affordability is a problem,” he adds.
Dr Mueed notes that biosimilars undergo a stringent regulatory process to ensure they closely match their reference biologic in terms of structure, efficacy, safety and quality.
“Regulators such as the Malaysian National Pharmaceutical Regulatory Agency (NPRA), US Food and Drug Administration (FDA) and European Medicines Agency (EMA) only approve a biosimilar if its safety and efficacy match the reference product, a process requiring extensive clinical data.”
Globally, more than 170 clinical studies have shown that switching from biologics to biosimilars results in no meaningful differences in safety or efficacy.
He adds that biosimilars are considered interchangeable with their reference biologics, allowing patients to switch treatments safely.
“Patients often move between conventional therapy, biologics and biosimilars, so not all patients receive biologics,” he says.
Dr Mueed was sharing his thoughts on the subject during a pocket talk at the 2025 Malaysia International Healthcare Megatrends conference held in Kuala Lumpur.
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A difference in price
The disease process that occurs in ankylosing spondylitis. — Photos: Wikimedia Commons
Biologics were the first medications proven to effectively target the inflammation that drives conditions such as rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
Lee Jin Choong, 45, is a patient advocate whose medical journey began unexpectedly when he was diagnosed with axial spondyloarthritis.
This is a chronic inflammatory disease that causes back pain and stiffness, primarily affecting the sacroiliac joints and spine.
ALSO READ: Ankylosing spondylitis: An uncommon, but debilitating, cause of back pain
“My doctors noticed unusually high inflammation markers during a routine health screening, even though I felt fine,” he recalls.
“After repeating the test three months later with similar results, I was referred to a rheumatologist.
“Following a consultation, physical assessment and X-rays, they found early fusion in my sacroiliac joint – a classic sign of ankylosing spondylitis, a form of axial spondyloarthritis.”
At first, Lee didn’t grasp the seriousness of the diagnosis.
“I wasn’t in much pain, so I didn’t think it was a big deal,” he says.
However, seven years later, his symptoms worsened dramatically.
“I started having shoulder and chest pain – I even saw a cardiologist because I thought it was my heart.
“I had completely forgotten about my earlier diagnosis.”
After about a year of uncertainty, Lee was finally referred to Universiti Malaya Medical Centre consultant rheumatologist Assoc Prof Dr Fariz Yahya.
“That was when my real treatment began,” he says.
Lee began treatment with biologics in 2024, before switching to biosimilars this year (2025).
For him, the transition made a major difference, especially financially.
“The treatment response has been the same,” he says.
“The most affordable biosimilars start around RM1,000, while biologics can cost twice as much.
“That price difference changes everything, for me and for many others who couldn’t afford treatment before,” he points out.
The cost of delay
Like Lee, many patients tend to ignore their diagnosis when there is little pain or visible symptoms, but the problem is that delays can lead to irreversible harm.
Lee admits that due to his lack of symptoms, he ignored his condition.
“I went over a year without treatment [after his symptoms started becoming severe], and by the time I finally started, the damage was already done,” he says.
“With ankylosing spondylitis, inflammation gradually causes the spine to fuse, creating what is known as a ‘bamboo spine’.
“The spine’s normal gaps close due to chronic inflammation until it becomes one rigid stick.
“This makes it very fragile – if I get into an accident, my spine could easily break,” he explains.
Lee is now unable to bend his back.
“When I was first diagnosed, doctors told me treatment wasn’t necessary if there was no pain, so I wasn’t considered a patient of interest.
“But that approach delayed my care,” he says.
Today, more doctors recognise the importance of early intervention in ankylosing spondylitis.
Lee also credits physiotherapy and sports medicine as key parts of his recovery.
“Physiotherapy helps manage pain and teaches self-care techniques, while sports medicine focuses on prevention, building strength and resilience.
Looking back, he considers himself fortunate that his condition was detected early, even though treatment began much later.
“Most patients aren’t as lucky.
“Many endure years of unexplained pain, sometimes over 15 years, surviving only on painkillers before getting a proper diagnosis.
“By then, irreversible joint and spinal damage has often occurred.”
Even in his case, just one year of delay led to permanent spinal damage caused by untreated inflammation.
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Lifestyle changes
It’s normal for any medication to come with side effects, and biologics or biosimilars are no exception.
An X-ray image of a bamboo spine in a patient with ankylosing spondylitis.
Assoc Prof Fariz points out that these treatments are well-studied and global usage has proven their safety.
“Most side effects are mild and temporary, such as a runny nose or sore throat in the first month, while serious risks, like infections, are monitored by doctors.
“Patients should be aware of warning signs and safety checks,” he adds.
He also notes that medication alone isn’t enough; education and a healthy lifestyle matters just as much.
Regular physical activity, nutritious eating, and managing underlying conditions like high blood pressure and diabetes can help keep symptoms at bay.
“Just as importantly, getting enough sleep and learning to handle stress are essential steps toward living better with arthritis,” he says.
As president of Arthritis Foundation Malaysia (AFM), Assoc Prof Fariz notes that the organisation’s mission is to raise awareness and support patients living with arthritis.
“We’ve set up the Arthritis Fund, which collects donations from the public and companies to subsidise the cost of biologics and biosimilars for patients who otherwise couldn’t afford them,” he shares.
AFM also runs a weekly PACE (People with Arthritis Can Exercise) class on Friday, which regularly attracts 10 to 15 patients to their centre in Petaling Jaya, Selangor.
The class is currently on hiatus, but will resume next year (2026).
For an arthritis patient in need of suitable treatment, access to biosimilars begins with consulting a rheumatologist, who will assess if the therapy is suitable.
“Not every arthritis patient needs these treatments, but for those who do, consulting a specialist is the crucial first step,” says Assoc Prof Fariz.
These treatments are available in both public and private hospitals.
Both Lee and Assoc Prof Fariz were speaking at a media roundtable held in Petaling Jaya, Selangor, which focused on Malaysia’s growing arthritis burden and the role of biosimilars in improving access to affordable treatment.
