Blog Big Molecule Watch February 06, 2020

Roche Fined $14M for Undermining Biosimilar and Generic Competition in Romania

On January 15, 2020, the Romanian Competition Council fined fined Roche Romania SRL €12.9 million ($14.2 million) following two investigations into what the Competition Counsel found to be Roche’s anti-competitive practices related to its cancer drugs.

In the first investigation, the Competition Council found that between 2017 and 2019 Roche adopted a commercial strategy aimed at eliminating competition and delaying the entry of biosimilars to MABTHERA (rituximab) and HERCEPTIN (trastuzumab).  The Competition Council estimated that biosimilars could have saved the Ministry of Health €7.1 million ($7.7 million).  As a result of this investigation, Roche was fined €9.5 million ($10.5 million).

In the second investigation, the Council found that between 2017 and 2019 Roche implemented a strategy to prevent patients from purchasing a generic version of TARCEVA (erlotinib), which is used for the treatment of lung and pancreatic cancers.  As a result of this investigation, Roche was fined €3.4 million ($3.7 million).

Roche told Regulatory Focus that they plan to appeal the Competition Council’s decisions in court.

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