Life-saving biosimilar drugs need fast approval

In this segment of CEO Talk, Director and Consultant Clinical Oncologist of Beacon International Specialist Centre, Dato’ Dr Mohamed Ibrahim A. Wahid calls for urgency in the approval of biosimilar drugs for cancer patients.

Dato’ Dr Mohamed Ibrahim A. Wahid, Director and Consultant Clinical Oncologist of Beacon International Specialist Centre delivering an educational talk on cancer during the Lavender Ribbon Campaign, organised by Duopharma Biotech.

FAST approvals would allow cancer patients in Malaysia access to the more affordable biosimilar drugs to treat cancer Malaysia is still lagging behind in terms of the availability of biosimilars in the local market although they are proven to be more affordable and help reduce cancer treatment cost.

For this, and many other reasons, biosimilar products that are currently not available in Malaysia should be given fast approval by the local authorities to allow patients access them soonest possible. 

Some of the biosimilar drugs to treat cancer are already being registered in the United States and Europe, and many countries have given priority reviews to the drugs, as treatment for cancer is very costly for the patients.

This will adversely impact on patients as well as their families and the respective nation’s healthcare budget. For example, a biosimilar for breast cancer called trastuzumab had already been approved by the Food and Drug Administration (FDA) in the United States in December 2017 and not long after that Thailand also registered the drug.

But, it was only approved and commercialised in Malaysia in late 2018, hence putting the patients at a disadvantage as the lower cost would have allowed more to gain access to the drug earlier.

According to a study by ASEAN Costs in Oncology (ACTION), 51 per cent of Malaysian cancer patients will face financial catastrophe within the first year of treatment.

Unless measurable steps are taken now to prevent non-communicable diseases like cancer, Malaysia will be in dire straits and burdened with high healthcare expenses in the next decade.

A biosimilar is a biologic medical product that is almost an identical copy of an original product. Biosimilars are officially approved versions of original ‘innovator’ products and can be manufactured when the original product’s patent expires.

The first biosimilar approval was for Zarxio (filgrastim-sndz), a biosimilar G-CSF myeloid growth factor used in supportive cancer care, which was approved back in March 2015. In 2018, three more filgrastim and pegfilgrastim biosimilar products were approved.

To date, 15 biosimilars have been approved in the United States, including four for oncology treatment which were approved in 2018.

Three out of the four oncology biosimilars have already gone to the market. Currently, there is an ongoing trial in Malaysia on an angiogenesis product and also Human Epidermal growth factor Receptor 2 (HER-2) to treat breast cancer.

It is encouraging to note that local pharmaceutical companies including Duopharma Biotech Berhad (formerly known as CCM Duopharma Biotech Berhad), (“Duopharma Biotech”) have started to take the initiative to commercialise products for breast cancer and leukemia.

With Duopharma Biotech’s soon to be established High Active Pharmaceuticals Ingredients (“HAPI”) plant this year, the first of its kind in the region, we can look forward to locally-made generic cancer therapies that are more affordable and accessible to the public.

Nonetheless, the authorities would be the main drivers in
pushing the biosimilar drugs in the country and all parties should be working together to ensure they are accessible to the patients not just to combat the disease but also to pursue early intervention which could greatly reduce the need for more expensive treatments,” he said.

Recently, Datuk Seri Dr Wan Azizah bin Wan Ismail, Deputy Prime Minister of Malaysia, had encouraged the usage of biosimilar medical products as seven out of ten deaths in Malaysia is caused by non-communicable diseases such as cancer.

She said that biosimilar drugs are good alternatives as such drugs would also encourage competition in the market and reduce the prices of medicine by 30 to 40%.

She added that on its part, the Government has taken several measures to combat, treat and reduce the number of cancer cases under the National Strategic Plan for Cancer Control (2016-2020).

Cancer is currently a major health issue across the Asia Pacific whereby about 4.2 million new cancer cases or 39% from worldwide statistics were recorded in the region, diagnosed among people living in the 15 most highly developed countries in Asia including Japan, Taiwan, Singapore, South Korea, Malaysia, Thailand,
China and the Philippines.

The number of new cancer cases in Malaysia is projected to increase by 54% by 2025 – from 37,000 cases in 2012 to 56,932 by then, with the top five cancers being breast cancer (14.5%) followed by colorectal cancer (12.1%), lung cancer (11.8%), cervical cancer (5.7%) and nasopharyngeal cancer (5.4%).

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The Petri Dish is malaysia’s first dedicated science newspaper. Through The Petri Dish we aim to engage the public on the latest developments on biotechnology.