Exploring the role of generics and biosimilars in more affordable, accessible and quality treatment
KPJ Damansara Specialist Hospital and KPJ Healthcare University (KPJU) consultant clinical and radiation oncologist Assoc Prof Dr Aminudin advocates for the increased use of biosimilars and generics to enhance accessibility and reduce treatment cost.
CANCER is a life-threatening disease and modern treatments often have high costs, exacerbating existing care inequities which can lead to loss of lives.
This pressing global concern is the focus of the 2022 to 2024 World Cancer Day campaign,through its theme, “Close the care gap”.
World Cancer Day is an initiative spearheaded by the Union for International Cancer Control (UICC), a Switzerland based non-profit organisation.
The focus of this initiative seeks to address the barriers cancer patients face due to disparities in income, education, and geography, as well as discrimination related to ethnicity, gender, age, disability, and lifestyle.
Over this three-year campaign, healthcare stakeholders aim to spotlight the significant progress that can be made in reducing the cost of treatment.
Modern cancer therapies, such as targeted and immunotherapies, offer precision and improved outcomes, including enhanced survival rates and quality of life.
However, their high cost can be a barrier, particularly for those requiring long-term care.
The broader use of affordable generic drugs and biosimilars in cancer treatment presents a viable solution to these financial challenges.
These non-proprietary agents are often several times less expensive than their branded counterparts.
They have the potential to substantially lower the cost of care, and their availability from multiple sources often ensures a stable supply.
In Malaysia’s healthcare landscape, where affordability and access are pressing concerns, these cost-effective alternatives play a crucial role in expanding access to cancer treatment.
Understanding generics and biosimilars Biosimilars are biological products designed to closely replicate the function of an original biological product, often referred to as an originator.
A key process in creating biosimilars is biotechnology.
Biotechnology is the use of living organisms or systems to develop or make products.
It spans a variety of fields, including medicine, agriculture, and environmental management.
In the context of medicine, biotechnology involves using living cells and biological molecules to produce medications and treatments.
For example, insulin for diabetes management and vaccines for disease prevention are products of biotechnology.
Biologics, produced using biotechnology within living systems such as plant or animal cells,include immunotherapies and certain targeted therapies used in cancer treatment.
These therapies are monoclonal antibodies that mimic the immune system to specifically target proteins within cancer cells or their surrounding environment, ultimately leading tothe destruction of those cells.
The non-branded alternatives undergo rigorous testing to ensure strict standards for safety and quality are met.
In contrast, generic drugs are chemically identical to their branded counterparts.
This chemical equivalence allows them to be significantly cheaper, as they require minimal regulatory testing by authorities such as the United States Food and Drug Administration (US
FDA) and Malaysia’s National Pharmaceutical Regulatory Agency (NPRA).
Biosimilars, derived from living organisms, require more rigorous testing to ensure they are interchangeable with the original drugs regarding effectiveness and safety, given their non-identical ingredients.
For example, certain biosimilars are designed to target and inhibit specific growth factors that supply tumours with essential nutrients and oxygen.
Similarly, some generic drugs are formulated to interfere with enzymes that regulate cell proliferation, thereby curbing the spread of cancer cells.
With these cost-effective options, healthcare systems can enhance access to vital treatments while maintaining the quality of care.
Reducing treatment costs
Chemotherapy, often used as a supplementary treatment following primary interventions like surgery or radiotherapy, is expensive and poses a heavy financial burden on patients.
The introduction of generic chemotherapy drugs for common cancers offers significant potential for cost savings and improved treatment access.
Studies indicate that these generics have substantially more favourable cost-effectiveness ratios once their exclusivity or patents expire.
Biosimilars and generics hold the potential to transform the cancer treatment landscape, making treatment more accessible and affordable in the future.–Stacey Wescott/Chicago Tribune/TNS.
Generics and biosimilars, being more affordable than their originator counterparts, provide a viable means to improve access to precise and effective cancer treatments, known as precision medicine in oncology.
This approach represents a hopeful future for cancer treatment, potentially saving lives by making it more accessible to patients.
KPJ Damansara Specialist Hospital and KPJ Healthcare University (KPJU) consultant clinical and radiation oncologist Assoc Prof Dr Aminudin Rahman Mohd Mydin highlights the transformative impact of generics and biosimilars on Malaysia’s healthcare system.
He notes that their availability makes cancer care more affordable and enhances the system’s capacity to deliver effective treatments. The cost of traditional cancer treatments in Malaysia can range from thousands to tens of thousands of ringgit, but generics present lower-cost alter- natives that improve access to essential cancer care.
Despite ongoing challenges, the acceptance and uptake of generics and biosimilars among healthcare professionals and patients in Malaysia have been steadily increasing.
The National Pharmaceutical Regulatory Agency (NPRA), under the Health Ministry, regulates the approval process to ensure these medications meet stringent standards for safety, efficacy and quality.
Generics and biosimilars have already begun to positively reshape Malaysia’s healthcare landscape, improving patient access and reducing costs.
While the adoption of biosimilars in oncology is still in its early stages, these alternatives are gradually influencing healthcare dynamics in the country.
Future trends and challenges
The use of generics and biosimilars is expected to grow as more branded drugs’ patent protection comes to the end of its term.
However, there are challenges to overcome, such as regulatory complexities.
The approval process for biosimilars is particularly intricate, necessitating extensive clinical trials and data to establish their safety and efficacy.
Malaysia’s approach for integrating generics and biosimilars into cancer care is making headway, though further improvement is needed.
Dr Aminudin notes that the government acknowledges the high cost of cancer care and has been working to broaden access by incorporating more generics and biosimilars into the national formulary.
Nonetheless, the limited availability and uptake of biosimilars, especially in oncology, remain obstacles.
Addressing these issues could lead to more affordable cancer care and improved outcomes for Malaysian patients.
