Drug Development Is the EU's Biosimilar Wave Faltering?

Data and analytics company Global Data has predicted that the arrival of biosimilar therapies in the EU will continue to fall in the coming years following a wave pattern that has been occurring since 2006.

London/UK — Global Data’s senior drugs database analyst Quentin Horgan notes that EU biosimilar development is currently in the downward trajectory of a wave that peaked in 2018, and it is likely that there are similar waves happening in the US and APAC markets.

Horgan comments: “Biosimilars come in waves of development and approval. In the peaks of these waves, we see a large surge of biosimilars in late-stage pipeline development alongside increases in the approvals of biosimilar products. These waves often coincide with the expiry of innovator biologics, as the loss of market exclusivity within a region provides biosimilar developers with a greater opportunity to enter a market and removes legal and patent barriers to their entry.”

Horgan continues: “The EU experienced this biosimilar wave ahead of regions such as the US and Asia-Pacific because the EU created the first biosimilar-specific approval pathway in 2005, and subsequently approved the first biosimilar somatropin in 2006. In addition, the region has had a strong uptake of biosimilars over brand biologics and, therefore, has one of the biggest biosimilar markets.”

The EU biosimilar wave shows an average increase of 69 percent in approvals between 2013 and 2018, with peak approvals of 13 in 2018. This corresponds with an earlier peak of biosimilar expirations in 2017, with twelve drugs expiring. The EU biosimilar wave subsequently slowed down as biosimilar approvals declined in 2019 and 2020 Horgan concludes: “We can use this wave pattern to predict a further fall in biosimilar development and approvals.”

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