WHO proposed exemption from biosimilar trials set to trigger biosimilar boom in India

As the World Health Organization (WHO) considers amending guidelines for evaluating biosimilars so that Phase III clinical trials can be waived for biosimilar products, India may take a greater interest in developing biosimilars.

Biosimilars continue to post monumental growth, with estimates suggesting that global sales topped $15 billion in 2020, representing a compound annual growth rate of 56% since 2015. Reports indicate the market is set to continue its double-digit growth, doubling in size to more than $30 billion by 2025, and over $60 billion by the end of the decade.

A draft guideline from the WHO eases the need for Phase III clinical trials for biosimilar products, and the UK has already incorporated the change into its licensing guidelines for these products. Similarly, India is considering revising its existing guidelines, although it has not decided whether to adopt the proposed changes in the draft WHO guideline or not.

Most biosimilars today cost between $100 million and $300 million to develop, with clinical trials accounting for more than half of the budget

Waiver will cut development costs significantly

"The waiver of Phase III clinical trial costs will significantly reduce the cost of developing biosimilars in developed markets (US/EU), resulting in a greater number of players, including those in India, focusing on biosimilar development and commercialisation," said a company stalwart, adding that the ultimate goal of biosimilars is to create a competitive biologics market that allows for significant cost savings.

Additionally, the official said, it would result in higher price erosion for biosimilars in the developed markets, consequently leading to an increase in demand, especially among uninsured populations.