WHO signs MOU with International Generic and Biosimilar Medicines Association to promote access
Full access to medicines is hampered by a variety of factors. Two important barriers are high prices and regulatory issues such as long lag times in bringing medicines to market.
To address these issues, Dr Tedros Adhanom Ghebreyesus, WHO Director-General, and Jim Keon, Chair of the International Generic and Biosimilar Medicines Association, today signed a memorandum of understanding.
The new agreement is an important step in WHO?s drive towards universal health coverage by underscoring the importance of generic and biosimilar medicines to increasing access to affordable, quality treatment.
WHO is an active supporter of expanding use of generic medicines: The vast majority of the products in the WHO Essential Medicines List are generic. WHO?s prequalification 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% of the medicines it prequalifies are generic. A recent independent study by McKinsey estimated WHO prequalification saves the world up to US$ 590 million every year. Every $ 1 invested in WHO Prequalification has a return in terms of savings of between $ 30-40.
WHO has also supported use of and access to generics through normative guidelines. Implementation of WHO guidance on interchangeability of generic medicines is further supported by the WHO List of International Comparators, which provides information on reference products for clinical trials into bioequivalence ? i.e. whether two different products achieve the same results. Another tool is the WHO Biowaiver List which describes generic medicines that are eligible for a waiver from such studies.
Regional and national regulatory normative guidance aligned with WHO guidance has now paved the way for the approval of many biosimilars with regulators. Last year, the Organization launched a pilot prequalification 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.
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.
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.
About Taj life sciences
A privileged Company for Generic Pharmaceutical products, Taj Life Sciences is a specialty Generic company, which develops and markets innovative products in the fields of cancer and infections, and more especially opportunistic infections or chemotherapy complications. Our targeted approaches, in areas where medical needs are insufficiently met, contribute to overcoming drug resistance and improving health and quality of life for patients. Taj Life Sciences ambition is to become a leading player in India and Europe in these fields by aligning innovation with patients needs.
Taj Life Sciences discovers, develops, manufactures, and delivers innovative human therapeutics. Taj Life Sciences is bringing safe, effective medicines from lab to manufacturing plant to patient. Taj Life Sciences is committed to advancing science to dramatically improve people?s lives. Taj Life Sciences focuses on innovative therapeutics with convenient application.