The Health November 2020 | Page 15

| Industry | november , 2020 | The Health


Biosimilars from the regulatory perspective

product , there would not be biosimilars in the market .
Chua agreed there was a lively competition whereby the innovators also competed to lower the prices .
Another point of discussion was what other aspects are taken into consideration , apart from cost , when choosing biosimilars over the reference products .
Dr Lim said while the cost is the mainstay , the quality of the biosimilar must also be considered .
“ If the biosimilar is similar and also has the same clinical effect , while at the same time has the same safety profile , then it is
use is pretty low ,” he said .
Based on the data from the National Diabetes Registry Malaysia , Dr Radhakrishna shared : “ Back in 2010 , we spent about US $ 325 per person while in 2017 , it tripled to US $ 980.4 per person .
“ We are spending lots of money . I think the era of using human insulin is something that we should probably keep in the past . We should move on and invest in better therapies .” Reference insulin or biosimilar insulin ? Undeniably there are concerns when it comes to biosimilars .
“ The most important thing we need to be satisfied with is how closely this molecule resembles the innovator .”
When biosimilar basal insulin was introduced and registered in Malaysia , the regulatory authorities requested for a postmarket surveillance study to collect data on the safety and the tolerance of biosimilar insulin in the Malaysian population .
“ Patients were evaluated for 24 weeks for safety , tolerability and efficacy .”
Based on the study , there were no new safety concerns and no unexpected adverse reactions . There were also no major safety concerns or new safety signals that were identified when using biosimilar basal insulin in routine clinical use .
The formulations were efficient , as expected for this class of product , in treating diabetes mellitus in Malaysia .
Benefits of biosimilar basal insulins
“ As research has shown biosimilar basal good enough .”
The manufacturing process should also be taken into account , according to Dr Radhakrishna .
“ There is concern about the safety . When the manufacturing process is not up to standard , it will undoubtedly impact safety .
“ The NPRA acts as a gatekeeper to make sure all three criteria of safety , efficacy and quality of a product are fulfilled before it is approved for the market . To ensure this , we also conduct inspections at manufacturing sites when necessary ,” assured Chua . — The Health
insulin is comparable to the innovator insulin , this gives us the confidence to go ahead with biosimilar basal insulin therapy and get more patients to get treated earlier . Then we could probably improve the early uptake of insulin in primary care .
“ Expenditure for treating diabetes complications can also be reduced as it can be used more widely ,” he said , adding it was also more reliable , predictable and technically better compared to what we are using right now , which is human insulin .
He also pointed out biosimilar basal insulin would allow accurate titration to fix the fasting glucose .
“ It will truly be one-dose-a-day insulin , which will not have much variability . It will be more predictable , there will be less hypoglycemia , and we will be able to get the dosage right .”
Apart from that , it gives the advantage of being affordable , therefore reducing a patient ’ s medication expenditure for insulin .
“ We can achieve cheaper procurement costs , and we could certainly put up more patients to be treated with good quality analogue . At the end of the day , you are getting more people on better insulin at a cheaper cost .
“ The time has come now for us to consider using high-quality biosimilar insulins because , not merely for the fact that we have a lot of patients to treat , but because our diabetic patients deserve better treatment .
“ It ’ s time that we move to the analogues as they have clear advantages compared to human insulin ,” he concluded .
The National Pharmaceutical Regulatory Agency ( NPRA ) seeks to educate and create awareness among all parties to ensure the effective and safe use of biosimilars .
NPRA Senior Principle Assistant Director Chua Hui Ming said : “ To ensure safe use , we encourage every medicine , especially biosimilars , to be prescribed with a trading name and International Non-Proprietary Name ( INN ) name .
“ If a suspected adverse drug reaction ( ADR ) is identified , it should be reported .
“ It is a shared responsibility between regulators , healthcare professionals as well as industry players and the public .”
Healthcare professionals play an essential role in contributing to the optimal uptake and safety use of biosimilars , especially on the clinical ground .
Chua was one of the speakers at a webinar on “ Biosimilars : A Case of More for Less ” organised by Duopharma Biotech Berhad recently where she provided some insight on biosimilars from the perspective of the regulatory agency .
Chua said the Ministry of Health ( MoH ) was working on a position statement on biosimilars .
Interchangeability between the biosimilar and reference products has also been a constant concern among regulators , health professionals , industry players and policymakers .
“ The NPRA does not endorse interchangeability because without established sufficient evidence , a reference product and corresponding biosimilar cannot be considered interchangeable .”
However , she said switching by the treating physician is allowed , taking into consideration the patient ’ s best interest and any local policies that may be relevant .
“ Nevertheless , we strongly discourage switching back and forth between the reference product and biosimilar or vice versa as the data on the safety impact is limited .”
At the pharmacy level , it is strictly prohibited to switch or auto-substitute without the treating physician ’ s consultation .
The NPRA functions as a secretariat to the Drug Control Authority and provides oversight throughout the medicinal product lifecycle as early as when a medicine enters a preclinical trial , clinical trial stage till the registration stage .
The NPRA strictly registers products which fulfil the QSE criteria . Even after the products enter the market , regulatory compliance is a must .
Development and registration process
Biosimilars are considered as a new biological medicinal product developed to be similar in terms of Quality , Safety and Efficacy ( QSE ) to an already registered , well-established , medicinal product , also known as the reference product .
A biosimilar is made using cells , materials and processes that may differ from the reference product .
Chua explained : “ Due to the variability aspect , a biosimilar can at best only highly resemble that of the innovator product , but not be identical .” She added variability was inherent in all biologics . “ Batch-to-batch variation is prevalent , and it is tough to guarantee a new batch of product is identical to the previous batch of the same products .”
Variability in biologics is also due to the manufacturing process , such as process improvement , technology enhancement and scaling up production due to demand . “ Safety and efficacy within this variability have been demonstrated in clinical studies and by real-life experience with the reference product . Also , in our human body , variability is widespread and is usually not problematic ,” Chua revealed .
“ The development of and reliable access to safe and reasonably priced biosimilars will undoubtedly improve healthcare outcomes . However , you have to do them right .”
Malaysia has already established a regulatory guideline for biosimilars since August 2008 . It was adopted and adapted European Medicines Agency ( EMA ) guidelines .
The registration guideline requires biosimilars to demonstrate close similarity in terms of QSE to the reference product . However , it is not meant to establish new clinical benefit in terms of efficacy and safety .
The review process of Biosimilar registration also involves key opinion leaders of relevant disciplines where the clinical studies report will be sent to them for comments .