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The Health | november , 2020
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Biosimilars : Safe , efficacious , value
During the current trying times , consumers are always looking to lower medication costs without compromising efficacy
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BY KHIRTINI K KUMARAN
A recent webinar themed “ Biosimilars : A Case of More for Less ” was timely as it discussed safe , efficacious , value of biosimilars compared to the reference products .
Under the current economic environment , consumers are looking at ways they can spend less on medications without compromising quality and efficacy . They want value for money .
A biosimilar is a biologic medical product highly similar with another already-approved biological medicine or reference products .
Biosimilars are approved according to the same standards of pharmaceutical quality , safety and efficacy that apply to biological medicines but are cost effective and affordable .
Duopharma Biotech Berhad organised the webinar on Sept 25 , 2020 . The speakers were Senior Principal
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Assoc Prof Dr Lim Soo Kun |
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Dr Radhakrishna Sothiratnam |
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Ms Chua Hui Ming |
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Prof Dr Abdul Halim Abdul Gafor |
Assistant Director from the National Pharmaceutical Regulatory Agency ( NPRA ) Chua Hui Ming and Dr Radhakrishna Sothiratnam , Consultant Internal Medicine Physician from Columbia Asia Hospital .
They spoke on biosimilars from the perspective of the regulatory agency and biosimilar analogue basal insulin , respectively .
The panel discussion was joined by Asso Prof Dr Lim Soo Kun , Consultant Nephrologist and Head from University Malaya Medical Centre and moderated by Prof Dr Abdul Halim Abdul Gafor , Consultant Physician and Nephrologist from Universiti Kebangsaan Malaysia . The panellists discussed the value and cost of biosimilars compared to the biological or reference products .
When it came to the cost , Dr Radhakrishna noted it was vital to get a good value product for the money spent . He was involved with the clinical study of biosimilar basal insulin and admitted
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he was at first skeptical of the efficacy of biosimilars .
But based on the result of the trial , he said : “ The clinical effect was similar , which means a biosimilar is as good as its reference product .
“ So , if this biosimilar is only going to cost you 50 per cent of the innovator product price , its best to discuss this option with your patients .”
Dr Lim added : “ Another benefit of biosimilars is that it puts pressure and competition on the company of the innovator product .”
He also noted without the innovator
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Biosimilar analogue basal insulin
Asia is the epicentre of the current diabetic epidemic , and Asian patients now account for 60 per cent of the world ’ s diabetic population . It is due to the rapid urbanisation , nutrition transition and shifts to adopt western lifestyles .
In the Asian population , particularly East Asians , diabetes tend to develop at a younger age and a lower Body Mass Index ( BMI ). And most of these patients have lots of visceral obesity .
Due to the progressive loss of pancreatic b-cell function in Type 2 diabetes , most patients will eventually require insulin therapy , after the Oral Antidiabetic Drugs ( OADs ) have failed .
Dr Radhakrishna Sothiratnam , Consultant Internal Medicine Physician from Columbia Asia Hospital , said : “ About four decades ago , China only had about less than one per cent of adults with Type 2 diabetes . However , by 2008 , the prevalence had soared to nearly 10 per cent .”
He was making a presentation on analogue basal insulin , the most common biosimilar medication , during a webinar themed “ Biosimilars : A Case of More For Less ” organised by Duopharma Biotech Berhad recently .
Basal insulin therapy in Asia
Currently , insulin is the most potent agent
against hyperglycemia . And injected basal insulin alone , is by far the most convenient initial regimen to supplement a patient ’ s endogenous insulin level .
Dr Radhakrishna added : “ Basal insulin can also be used in combination with other OADs .”
However , there are few setbacks when it comes to insulin therapy .
According to him , insulin initiation in Asian patients is delayed by approximately nine years , whereas in the western population , it is about six to seven years .
“ We do not good results because we tend to start insulin , when the patient , who has diabetes for over 10 years and prolonged use of OADs , gets a complication .”
“ This is not ideal because insulinnaïve patients without microvascular complications will respond better to the therapy than those with complications .”
The biggest challenge with insulin therapy , however , is the technicality difficulties .
“ Insulin is still an injection-based treatment , a subcutaneous injection , which gives rise to the fear and anxiety about taking an injection .”
Apart from the injection aspect , the technical difficulties associated with injectables is the need for constant monitoring as well as correct dosage titration .
“ Apart from being late in the initiation , we have also got suboptimal titration . We take our own sweet time to titrate , and that does not help the patients . When we are not doing the titration properly , and the patients then do not take insulin regularly , then they end up getting hypoglycemia .”
Dr Radhakrishna noted the fear of hypoglycemia also prevented patients from being titrated to the optimum dose .
Another problem encountered in the Asian context was glucose variability .
“ Because of the difficulties to adjust and to get insulin dosages right , the glucose readings tend to be inconsistent . Sometimes the reading fluctuates , not predictable and not very consistent .”
Need for a better basal insulin
“ We need to have better basal insulin for our patients ,” he stressed .
“ Especially for the elderly and those who have comorbidities such as cardiovascular disease , chronic renal disease and have a higher risk of hypoglycemia , to allow them to get improved glycemic control .”
He added for the basal insulin therapy to work , it needed to be initiated and intensified early and quickly .
“ And last , but not least , the patients are investing . They are spending their own money and doing self-titrating . We have to make their investment worthwhile so that they get good control with good titration .” He also commented on the cost of managing diabetes in Malaysia . “ The use of human insulin is more common in Malaysia , while analogue insulin