Regulatory Focus™ > News Articles > 2020 > 1 > Romania Fines Roche $14M for Undermining Biosimilar, Generic Competition

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Posted 27 January 2020 | By Zachary Brennan 

Romania Fines Roche $14M for Undermining Biosimilar, Generic Competition

The Romanian Competition Council last week fined Roche’s Romanian subsidiary €12.9 million ($14.2 million) following two investigations dating back to 2017 that uncovered how the company blocked access to cheaper versions of its cancer medicines.

The council found that Roche employed various tactics to delay competitors from making biosimilars of the company’s aging blockbusters MabThera (rituximab) and Herceptin (trastuzumab). The president of the competition council estimated that biosimilars could have saved the Ministry of Health more than €7 million ($7.7 million).

"The companies producing innovative medicine need to focus on developing and placing new, more efficient medicines on the market to bring improvements to the patients' condition and not on exploiting the patent medicine for which there are cheaper alternatives," said Bogdan Chirițoiu, president of the Competition Council.

The other investigation involved the cancer drug Tarceva (erlotinib), and the council found that the company used the Roche Patient Card and its call center to help patients pay for Tarceva so that they would not purchase another similar medicine.

A Roche spokesperson told Focus: "Our company will appeal in court the CC decisions in the investigations nr. 1138/2017 and 1127/2017, because the CC did not consider series of proofs supporting the company's innocence and in bad faith completely ignored a final court decision, which is establishing our innocence, in the investigation on the centralized acquisition of oncology products.

"Besides the court actions against the two decisions, we are reserving our right to submit penal complaints against all those who were involved in issuing these decisions, which are manifestly biased and lacking professionalism," the spokesperson added.

By comparison, in the US, Tarceva generics launched last May and biosimilar versions of rituximab and trastuzumab have also launched more recently, with prices of about 25% off the wholesale acquisition cost of the reference products.

Romanian Competition Council

Editor's Note: Article updated on 1/28/20 with comment from Roche.


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