Competition law enforcement in the pharmaceutical sector has been vigorous in recent years with regulators focusing on a variety of issues including denigration strategies, lifecycle management patent strategies, pricing rebates, and excessive pricing.

In an article recently published in Concurrences, we examine the case law and enforcement practice in this area and apply it to a particular type of pharmaceutical product: biologic drugs and biosimilars.

The article considers market definition concerning biologic drugs and biosimilars, reviewing European Commission and national case law concerning mergers and abuse of dominance cases involving biologics/biosimilars. It then examines how the existing framework in abuse of dominance cases can be applied in the area of biologics/biosimilars taking the specific characteristics of those products into account.

The article concludes that, although several elements from the existing cases could be implemented in biosimilar cases, various fact-specific differences will likely lead to a more nuanced legal approach both in market definition and in the assessment of potentially anti-competitive conduct.

The full text of the article can be accessed on the Concurrences website here (no subscription required).

This article was written for Concurrences and co-authored by Kyriakos Fountoukakos (Global Head of Competition, Regulation and Trade) and Violetta Meli (previously an Associate (Intern) at Herbert Smith Freehills, currently an Associate at Gowling WLG).

 

Kyriakos Fountoukakos
Kyriakos Fountoukakos
Partner, Brussels
+32 2 518 18 40
Peter Rowland
Peter Rowland
Of Counsel, Brussels
+32 2 518 18 470
Max Kaufman
Max Kaufman
Senior Associate, London
+44 20 7466 2898
Emily Bottle
Emily Bottle
Senior Associate, Milan
+39 02 3602 1402
Priyanka Madan
Priyanka Madan
Senior Associate, Milan
+39 02 3602 1389