CCI to investigate Swiss drugmaker Roche over breast cancer biosimilar

By Divya Rajagopal, The Economic Times | April 26, 2017

MUMBAI: The Competition Commission of India (CCI) will investigate Swiss drugmaker Roche over alleged attempts to block competitors from selling breast cancer drug Trastuzumab.

The investigation has to be completed in 60 days.

CCI’s action is in response to a complaint filed by Mylan and Biocon, who have together developed biosimilar version of Roche’s blockbuster drug that is most commonly prescribed for the treatment of breast and metastatic gastric cancer.

A biosimilar is a drug that is almost an identical copy of the original biologic drug.

Biocon and Mylan have alleged that Roche denied market access to its competitors in contravention of Section 4(2)(c) of the Act. Besides, violation of Section 4(2)(a)(ii) imposition of unfair prices, Section 4(2)(a)(i) for imposition of unfair conditions, Section 4(2)(e) of the Act for leveraging and Section 4(2)(b)(i) for limiting or restricting the market.

In their petition the two companies have said Roche kept competition out through an array of activities like influencing regulatory standards, raising unwarranted concerns regarding the safety and efficacy of biosimilars, influencing tender conditions and abusing the legal process to stall approval and marketing of the biosimilar of Trastuzumab.

In its 36­page order, CCI Chairman Devendra Sekri noted that prima facie Roche Group has tried to influence regulatory authorities, especially with regard to its court cases, where it tried to create an impression about the “propriety” of the approvals, the safety and efficacy of biosimilars in the medical fraternity, including doctors, hospitals, tender authorities, institutes etc.

“When seen collectively (the allegations), prima facie, appear to be aimed at adversely affecting the penetration of biosimilars in the market,” the order said.

“The letters/communications sent to hospitals, authorities such as DCGI, NPPA or tender authorities or representations made before doctors regarding safety issues in case of biosimilar in general and of the informants’ drugs in particular, may not have individually affected the market for informants’ drugs,” the order said.

However, CCI noted that seen collectively in the background of surrounding facts and circumstances, the allegations against Roche appear to be a part of the bigger plan/strategy of Roche Group to eliminate competition posed by biosimilar to Roche’s products in the relevant market.

CCI cleared Roche of any wrongdoing regarding unfair prices on the drug but said the company denied market access to competitors and was in contravention of section 4(2)(c) that warrants detailed investigation in the matter. “We are reviewing the order and cannot comment at this point,” Roche said in a statement to ET.

Biocon founder Kiran Mazumdar Shaw did not wish to comment on the order. However, the Biocon spokesperson said, “We welcome the decision of the Competition Commission of India. A fair and ethical competitive environment will enable access to affordable life­saving therapies to larger patient pools with unmet needs.”

Globally Roche sells Trastuzumab under the brand name of Herceptin, however in India the company sells the drug under the name of Biceltis (priced at Rs 75,000 for 440mg) and Herclon.

Though India sales of the drug are not known, in 2016 Herceptin recorded a sales worth $6.5 billion globally.

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This entry was posted in Biologics/Biosimilars, Campaign for Affordable Trastuzumab, Cancer, Uncategorized and tagged , , , , . Bookmark the permalink.

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