| MUMBAI, April 26
MUMBAI, April 26 India's antitrust regulator has
ordered a probe into Swiss drugmaker Roche for allegedly
using anti-competitive practices to restrict cheaper copies of a
blockbuster cancer drug from reaching patients.
Trastuzumab has been a mainstay of Roche's profit for years
and brought in global sales of about $6.7 billion in 2016, but
it has been challenged in the last three years by biosimilars
which are sold at about a 25 percent discount to the original.
India's Biocon and U.S. firm Mylan, which
together sell biosimilars of the drug in over a dozen countries
including India, filed a complaint with the Competition
Commission of India (CCI) last year alleging Roche misled
doctors and regulators to thwart competition to trastuzumab.
India, with among the highest number of cancer patients in
the world, is a big market for trastuzumab, which is indicated
to treat certain forms of breast and gastric cancer.
Roche first launched the drug in India in 2002 and sells it
for about 75,000 rupees ($1,170) for a 440 mg vial.
In an interim order released on Tuesday, the CCI said it
found merit in Biocon and Mylan's arguments, and ordered its
director general to conduct a "detailed investigation" and
submit a report within 60 days.
"Roche adheres to all applicable laws and regulations in
countries where it operates," Roche spokeswoman Shilpika Das
said in a statement. "We are fully committed to cooperating with
the authorities in India."
Biocon said it welcomed the CCI's order, which although not
final, but the investigation could result in penalties, a lawyer
at the Delhi High Court, who declined to be named, said.
Roche, which has been engaged in a legal tussle with Biocon
and Mylan since 2014, has the option of filing a petition to
contest the order, the lawyer added.
In their complaint, Biocon and Mylan allege Roche wrote to
doctors, hospitals, and state and federal regulators, misleading
them about the safety of efficacy of the biosimilar versions.
"When seen collectively in the background of surrounding
facts and circumstances, they 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," the CCI said in its order, made public on Tuesday.
($1 = 64.0900 Indian rupees)
(Editing by Alexander Smith)