NGOs ask WHO to update Guidelines on Similar Biotherapeutic Products for facilitating access to new biologic medicines

A large number of NGOs working in the health sector have urged the World Health Organization (WHO) to update the WHO Guidelines on Similar Biotherapeutic Products for facilitating access to New Biologic Medicines. In a letter to Prof. Klaus Cichutek, chairperson, Expert Committee on Biologic Standardization (ECBS), WHO, the Civil Society Organizations asked the ECBS to update the 2009 WHO Guidelines on Evaluation of Similar Biotherapeutic Products at its upcoming meeting as mandated under the WHO resolution WHA67.21. This is a critical step to expedite access to the biologic medicines included in the WHO Model List of Essential Medicines (EML), they stated. In the letter, the NGOs pointed out that current evidence suggests that biotherapeutics therapies (BTPs) play an important role in advancing therapeutic outcomes for several autoimmune and degenerative diseases and in cancer treatment. However, BTPs are extremely expensive and consequently not accessible to patients, especially in Low and Middle-Income Countries (LMICs). For example, the cost of one vial of adalimumab (for the originator product Humira from AbbVie) would cost about US$ 1,000 - almost equivalent to the average annual wage in a low-income country. The high prices are a reflection of protected monopolies in the biotech sector. Unlike in the case of generic equivalents of small molecule originator drugs, there is no effective competition in the market for BTPs even in situations where the patents of the originator molecules have expired. Beyond the technological or intellectual property barriers, regulatory challenges are the main reason for the lack of competition and therefore high prices

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