The Health | november , 2020
| Industry |
Biosimilars : Safe , efficacious , value
During the current trying times , consumers are always looking to lower medication costs without compromising efficacy
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
Assoc Prof Dr Lim Soo Kun
Dr Radhakrishna Sothiratnam
Ms Chua Hui Ming
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
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
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