KUALA LUMPUR, Oct 25 – The World Health Organisation (WHO) and the International Generic and Biosimilar Medicines Association (IGBA) have entered into a partnership to promote access to medicines, by addressing key issues such as high prices and regulatory problems.
“The new agreement between WHO and IGBA highlights the role of the pharmaceutical industry in helping WHO maintain tools that can facilitate registration of generic and biosimilar medicines.
“It will facilitate cooperation between the two organizations to reduce the burden of clinical trials for biosimilars, speeding up registration and increasing access,” WHO said in a statement posted on its website.
WHO is an active supporter of expanding use of generic medicines.
The organisation said that the vast majority of the products in the WHO Essential Medicines List are generic.
WHO’s pre-qualification programme – which assesses the quality of priority medicines supplied by UN agencies and other organizations in low-income countries – has prioritized generic medicines as a way to treat more people with the funds available; around 70 per cent of the medicines it pre-qualifies are generic.
A recent independent study by McKinsey estimated WHO pre-qualification saves the world up to US$ 590 million every year. Every $ 1 invested in WHO Pre-qualification has a return in terms of savings of between $ 30-40.
Regional and national regulatory normative guidance aligned with WHO guidance have now opened pathways for the approval of many biosimilars with regulators.
WHO said that last year, it had launched a pilot pre-qualification project for biosimilars for two anti-cancer drugs: rituximab and trastuzumab.
“In parallel, WHO is working to increase reliance between regulatory authorities to facilitate registration of generics and biosimilars, thereby getting the products to patients quicker.
“It is an important first step towards increased collaboration with the generic and biosimilar industry for long-lasting impact on access to health products and progress towards universal health coverage,” it added.