A story of less for more. A dive into biosimilars.
“MANY are either unaware of biosimilars or misunderstand what biosimilars actually are.” Aida Jaafar, the General Manager of Ethical Specialty Business from Duopharma Biotech Berhad says.
Duopharma Biotech is determined to spread the awareness of the practicality of biosimilar products. “Our aim is to educate the practitioners as well as the public about biosimilars. I believe education is the way forward.”
“Biosimilar drugs at its essence are not identical copies of the reference biological product. It can however, very closely mimic the function and effect of the reference biological product. Thus the name. But that does not mean it is any less effective. It is safe to say that it carries similar efficacy and quality of the reference product,” Aida says.
In other words, although biosimilar drugs are manufactured by a different manufacturer from the reference product, a biosimilar needs to prove it is as safe and effective as the reference product before it can be approved for use.According to Aida, the public is generally wary and sceptical towards the economically priced drugs.
“It is understandable. However, there have been clinical studies confirming its safety and efficacy. The drugs have also went through rigorous testing before it can be allowed in the market. The drug regulation in
Malaysia is very strict and without evidence- based findings, the biosimilar drugs would never have been allowed in the Malaysian market.”
Furthermore, Aida says the biosimilar insulins are now being supplied to government hospitals in Malaysia as a cost-effective alternative.
Why biosimilar products are more cost-effective
When a new drug is created, the active ingredients and manufacturing process is protected by patent law. This is to allow the innovator company recoup the cost of R&D, testing, and manufacturing.
“Without the cost of discovering the original drug molecule and the early clinical trial stages, the biosimilar can be offered at a lower price compared to the reference product. However, biosimilarity must be proven before commercialisation. The biosimilar must have highly similar quality, efficacy and safety as the reference product,” she says.
Besides helping the patients reduce their medication cost, biosimilars create balance in the pharmaceutical market.
Aida says: “The existence of biosimilar will create competition with the innovators. This prevents them from monopolising the pharmaceutical market by providing more affordable options,” she says. “In addition, this gives the middle and lower income population access to affordable insulin to manage their type 1 or 2 diabetes.” — The Health
Reducing patients’ burden with biosimilar insulins
As a cost effective product that emphasises safety and efficacy, biosimilar insulins provide for more patients to access quality diabetes care with confidence and sustainability.
Diabetes is a major health concern in Malaysia. The demand for insulin has increased in the last few years due to the estimated amount of 3.6 million diabetes patients among Malaysian adults.
Recently, a biosimilar insulin received regulatory approval to help manage the cost of diabetes for the middle and lower income population.
“If patients were to pay for their insulin, it would easily come to around RM200 a month if they were to pay out of pocket,” Dr Radhakrishna Sothiratnam, the Consultant Internal Medicine Physician of Columbia Asia Hospital Seremban informs.
“And that excludes other medications to treat other concomitant medical illnesses such as hypertension and dyslipidemia.”
Dr Radhakrishna has been advocating the prescribing of biosimilar insulins to his patients as a cost-effective treatment alternative. “A biosimilar insulin costs around RM100, half of the price of what the innovator brand is set at.”
A more cost effective solution
A more competitively priced insulin for diabetes? Is it safe? Dr Radhakrishna says that any generic biologic medication such as insulin to gain market access in Malaysia is required to be subject to strict regulation and scrutiny.
“When an application for a generic version of a biological medication were to be made to enter the Malaysian pharmaceutical market , the National Pharmaceutical Regulatory Agency will insist on a local patient population study to be conducted to assess for efficacy and safety of the biological medication.”
Columbia Asia Hospital Seremban was one of the four sites involved in performing the efficacy and safety study for a biosimilar insulin. Other sites included Hospital Putrajaya, Hospital Kuala Lumpur, and University Malaya Medical Centre.
Because of the centre’s involvement in the study, Dr Radhakrishna had first-hand experience in switching diabetic patients’ insulin to the biosimilar insulin. “We did the most switching from a variety of different insulins to the biosimilar.”
He says that the centre’s findings are significant, given the varied brands of insulins they have switched to the biosimilar.
He also adds that patients in private healthcare are more careful and mindful of their medication. “When patients have to pay for the insulin, then they will ask more questions. Why is the biosimilar half the price of the insulin they are used to? How effective will it be? And is it safe?”
The study was done for six months, and Dr Radhakrishna found that the results exceeded his expectations. “The data we have collected showed encouraging glucose control and getting more patients to their glucose targets.”
Dr Radhakrishna is happy to note that most of his patients currently prescribed with the biosimilar insulin are doing well. All patients enrolled at Columbia Asia Hospital Seremban for the study has continued to use the biosimilar insulin till today.
A common misconception
Biosimilar drugs are often confused with generic drugs. Both are marketed as cheaper versions of costly innovator drugs. Both are available when drug companies’ exclusive patents on expensive new drugs expire. And both are designed to have the same clinical effect as their pricier counterparts.
But biosimilar drugs and generic drugs are quite different.
While generic drugs are identical to the original in chemical composition, biosimilar drugs are ‘highly similar’ although they may have used entirely different materials in the manufacturing process to achieve the same therapeutic andclinical result.
Another key difference is that generics are copies of chemical moieties, while biosimilars are modeled after biologics that use living organisms as the base ingredient.
A better solution
“With the biosimilar insulin, cost becomes a lesser burden for patients from the middle to lower income group. And seeing such good results for the last two years that I have prescribed it to my patients, I believe it is just as good as the innovator’s product.”
Dr Radhakrishna urges more widespread nationwide use of the biosimilar insulin, as it can help provide more patient coverage by the government for diabetes care. “The same amount of allocation for insulin can acquire double the amount of the insulin itself if biosimilars are to be used.” — The Health
With the biosimilar insulin, it becomes less burdening for patients from the middle to lower income group. And seeing as the results seen for the two years I have prescribed it to my patients, I believe it is just as good if not better than the innovator’s product.”