Value in Health Regional Affairs: Developing Generic Drugs for Rare Diseases

Orphan drug development in the US and EU languished for years due to high development costs and low sales until it was bolstered by legislative action. While this has brought powerful therapeutics to patients, these drugs are still prohibitively expensive. In a new Value in Health: Regional Issues article, learn about the challenges of developing generic orphan drugs and the value they could bring to patients and drugmakers.

According to the authors, “Generic drug development is more beneficial for patients living in developing countries regarding treatment costs. Some of the generics are developing with advanced modes of administration and additional clinical benefits to cure multiple symptoms with a single drug. Given that the biosimilars are providing 100% bioassays, the doctors can consider the generics while prescribing the drugs for diseases with high treatment costs. The health authorities of developing nations are providing additional incentives such as orphan drug status for rare disease drugs that will benefit both generic manufacturers and middle-income people who cannot afford for the treatment of rare diseases.”

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(Source: Value in Health Regional Issues, May 2023)