Mumbai: The Competition Commission of India (CCI) said on Friday that the Roche group tried to block market access for Bicon Ltd and Mylan Pharmaceuticals’s biosimilars (generic biotech drugs) of its Trastuzumab drug used in the treatment for early breast cancer and metastatic gastric cancer. In its interim order, CCI said it had enough reason to order an investigation by its director-general into whether the Roche group abused its dominant position in the market. It cautioned that this order should not construed as “expression of final opinion on the merits of the case.”
In July 2016, Mylan Pharmaceuticals and Biocon approached the competition regulator alleging anti-competitive conduct by Roche to protect and maintain its monopoly on Trastuzumab. The petitioners alleged that Roche misused its dominant position to implement a series of actions such as writing to doctors and authorities on safety of their biosimilars to impede their entry and growth.
The competition watchdog ruled that Roche’s communications to various authorities such as Drugs Controller General of India (DCGI), National Pharmaceutical Pricing Authority (NPPA) and doctors regarding the safety and clinical testing of biosimilars by Mylan and Biocon was aimed at eliminating competition.
“When seen collectively in the background of surrounding facts and circumstances, they (letters and communications to authorities and doctors) only appear to be a part of the bigger plan/strategy of Roche Group to eliminate competition posed by biosimilars to Roche’s products in the relevant market,” said the CCI order.
The commission also noted that influencing doctors by raising concerns on safety of a drug will affect any company which does not have a strong marketing channel.
“Creating any iota of doubt in the minds of doctors can adversely affect the market for biosimilars, which is prescription induced, is beyond repair. Such disparagement may also have ripple effects within the medical community. In this scenario, those biosimilar manufacturers who do not have strong marketing channels amongst doctors may be forced out of the market because of abusive denigration by a dominant player,” said the CCI order.
“Prima facie, it appears to the Commission that Roche Group has shirked such responsibility (of a dominant player) and indulged in abusive conduct, “ the order said.
“We welcome the decision of the Competition Commission of India. A fair and ethical competitive environment will enable access to affordable life-saving therapies to larger patient pools with unmet needs,” a Biocon spokesperson said in an email.
A spokesperson for Roche said that the company was reviewing the order and cannot comment at this point.
While the commission ruled that Roche abused its dominant position to partially deny entry to other companies to produce and distribute Trastuzumab it did not impose a penalty and ordered an investigation.
“It is a subject matter of investigation as to whether their (the petitioners’) market shares could have been higher absent the alleged anti-competitive strategies adopted by Roche Group,” said the CCI.
The Commission also did not find the Roche group to have contravened certain other sections, as alleged by the complainants, for example, on unfair pricing.
This is the second legal win for the Mylan and Biocon which were facing a challenge from Roche for sale of the biosimilar drug for three indications—metastatic breast cancer, early breast cancer and gastric cancer.
On 3 March the Delhi High Court ruled that the two companies could manufacture and sell their biosimilar versions of Trastuzumab.
Roche had challenged the sale of drugs by the petitioners even after they had received approvals to do so.
Roche had opposed certain paragraphs in the product inserts for the additional indications, and claimed that Biocon and Mylan were passing off clinical tests conducted by Roche as theirs.