OBJECTIVES

Since the first EU-approved biosimilar in 2006, Sandoz’s Omnitrope^® (somatropin), Europe has experienced a flood of biosimilar approvals and launches, which can offer substantial payer savings. However, in the US the biosimilar approvals pathway was only established in 2010, and the first biosimilar approval, Sandoz’s Zarxio^®, came 5 years later. This research aimed to compare EU and USA approvals and launches of biosimilars to date.

METHODS

Publicly-available data has been scanned to assess the number of approved and launched biosimilar products on the EU and US markets, as well as the associated patent expiry dates associated with the innovator brands (as of 16/01/2019).

RESULTS

There are over 50 biosimilar products with marketing authorization by the European Commission in the EU, spanning 15 brands, of which 13 (86%) have been made commercially available. In the US, 16 biosimilar products in 9 brands have been FDA-approved, out of which only 6 (38%) have been made commercially available. This is mainly due to ongoing patent barriers in the USA for Humira^®, Enbrel^® and Herceptin^® biosimilars. By contrast, in Europe, only one approved mAb biosimilar class is currently prevented from launching due to patent issues (Avastin^®).

CONCLUSIONS

While the biosimilar market in Europe has reached its teenage years, the US is taking baby steps towards widespread biosimilar availability. The reasons behind this phenomenon are complex and span multiple facets of the pharmaceutical industry, including regulatory, legal, intellectual property, clinical, and commercial aspects. Nevertheless, in both markets complex pricing wars are beginning to take place with multiple biosimilars of the same brand reaching the market. The US biosimilar market is gaining momentum and holds the promise of significant savings for payers as well as patients. Nevertheless, significant roadblocks remain, including aggressive patent protection strategies, insufficient price discounts, and additional clinical requirements to prove interchangeability.