Pharmaceutical News
First WHO prequalified biosimilar to uphold patients’ medication rights
2020/02/09

Drug fees account for about one quarter of the NHI annual spending in Taiwan.  In 2019, the NHIA spent over NT$180 billion on drugs, including NT$30 billion on biologics.  Many major drug companies have been engaging in the production of biosimilars after the reference products’ patents expire.  As of now, 10 biosimilars have obtained the marketing authorization in Taiwan.  Dr Yang Chih-Liang, a former MOHW minister, pointed out that biosimilars may provide a solution for the NHI’s financial crisis. 

The WHO and International Generic and Biosimilar Medicines Association (IGBA) signed a memorandum in 2018 with a view to increasing patients’ access to drugs.   The WHO recently prequalified a biosimilars which could significantly reduce the cost of breast cancer treatments.  The prequalification system provides low-income countries an opportunity to access new drugs. The WHO will include prequalified drugs in its procurement list and supply the life-saving drugs to countries in need. 

Dr Yang pointed out that if biosimilars have the same quality as the reference products, then there is little ground to reject biosimilars.

Dr Yang continued that the WHO’s pledge is a declaration of human rights as low drug prices will ensure equal access to new drugs.  However, there are two pre-conditions: 1. the biosimilars must have the same quality and efficacy as their reference products; 2. there must be a robust review system.

At present, most biologics are for rheumatism and cancer target treatments.  However, the high costs have imposed a heavy financial burden on many governments.  The Taiwanese government needs to address the issue of an increasing NHI bill associated with an ageing society.

The launch of biosimilars has attracted great attention of the health authorities worldwide.  Many western countries have already established relevant regulations or incentives to encourage the use of biosimilars.  Savings are then directed to the treatments of severe diseases or the introduction of innovative health technology.

So far, 10 biosimilars have already reached the market in Taiwan.  Four of them are reimbursed by the NHI.  The NHI reimbursement price is set at 75-85% of the price of reference product.  Dr Yang Chih-Liang reckoned that the authority should reduce the review time and set up a pricing policy which could not only encourage the manufacturers to engage in the R&D of biosimilars, but also be accessible and affordable for all.

【2020-02-05 / United Daily News】