Collaboration vs.Competition: Patent Cliffs

The biosimilar business is growing increasingly fragmented among smaller firms, even as larger corporations are merging. Biosimilars are being developed by more than 40 smaller companies, many of which have no prior experience in the field. Long-term viability and supply reliability are threatened by this fragmentation.

- Alice Zeng, Senior Consultant, Clarivate

Patent cliffs will be one of the originator's biggest pain points in the next 3-5 years. Between the originator and biosimilar developer, competition is generally more than collaboration. It depends on the different markets and biosimilar developers' volume/growth stage. It's a commercial decision with ROI.

In mature EU markets, stakeholders are well-educated so that we can see biosimilars' deeper and quicker market penetration. Sufficient competition causes lower prices and a limited profit margin. Biosimilar developers also have the ambition to establish their brands, and some have been trying to expand to novel biological products.

To effectively counter biosimilar competition, originator companies are implementing various proactive strategies, including developing second-generation products, product reformulations, improvements in dosing methods, and advancements in supporting devices.

The entry of Humira biosimilars had a profound impact on the European adalimumab market. Following the launch of biosimilars in 2018, Humira sales in Europe saw a remarkable decline, with adalimumab biosimilars capturing approximately 60 per cent volume share within three years. AbbVie has adopted an aggressive approach to mitigate biosimilar competition, implementing price reductions of up to 80 per cent in specific European markets, offering discounts ranging from 10 per cent to 80 per cent during government tender processes, and securing settlement agreements with biosimilar manufacturers for early entry in Europe, while strategically delaying US launches until 2023.