Biologicals patent expiries

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Biologicals patent expiries

Biosimilares/General | Posted 13/11/2015 1 Post your comment

Biosimilars are now a reality. The European Medicines Agency (EMA) approved its first biosimilar back in 2006 [1] and, with the increasing price of new biologicals and continuing pressure on healthcare budgets, biosimilars are expected to make up an increasing share of the biologicals market.

There are also more than 200 new biotechnology products in the pipeline (phase II to registered), all of which could be future targets for biosimilars.

Estimated patent expiry dates for just some of the best-selling biological molecules are shown in Figure 1.

Figure 1: Patent expiry dates on best-selling biologicals

Although the European Union (EU) previously defined a period of 10 years data exclusivity, this was revised at the latest review of pharmaceutical EU legislation to the following:

Ten years if the reference product is centrally approved or application to the centralized procedure has been made before 20 November 2005. Or eight years data exclusivity + 2 years market exclusivity + 1 year possible extension if a full dossier is submitted on or after 30 October 2005 via a national procedure or after 20 November 2005 via the centralized procedure [3].

The expiration of patents and other intellectual property rights for originator biologicals over the next decade opens up opportunities for biosimilars to enter the market and increase industry competition. Price reduction strategies should increase adoption among physicians and patients alike, spurring increases in the biosimilars market share.

According to a report by Frost & Sullivan the global market for biosimilars will rapidly expand more than 20-fold in the next five years. The biosimilars market is expected to increase from just US$1.2 billion during 2013 to US$23 billion in 2019. Demand is being fuelled by governments around the world turning to biosimilars as a cheaper option to reduce healthcare costs. Government initiatives, strategic collaborations and increasing incidents of new diseases are also increasing the value of the market. Deeper penetration into the markets in Europe, Japan and the US, as well as emerging economies in Asia and Latin America is also helping to increase the biosimilars market share.

Major companies investing in the biosimilars market include Amgen, Biocon, Biopartners, Dr Reddy’s Laboratories, Hospira, Intas Biopharmaceultical, Mylan, Sandoz and Teva.

Editor's comment
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2013’s biggest patent expiries

2012’s biggest patent expiries

Reference
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 13]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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