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Nov 30 Pfizer Inc said on Wednesday its
experimental biosimilar of Roche Holding AG's
blockbuster breast cancer treatment Herceptin was found
comparable with the branded version in a key study.
Biotech drugs such as Herceptin are made in living cells,
and then extracted and purified. They are more complex than
traditional drugs and cannot be copied with precision.
Unlike generic drugs, which are interchangeable with their
branded counterparts, biosimilars approved by the U.S. Food and
Drug Administration to date are not considered interchangeable.
Several companies are developing biosimilar versions of
top-selling biotech drugs. The allure is clear, with insurers
counting on the steep discounts. U.S. pharmacy benefit managers
are already trimming brand-name drugs from their rosters.
Pfizer tested the safety and effectiveness of the drug,
PF-05280014, in combination with chemotherapeutic agent
paclitaxel against Herceptin and paclitaxel in previously
untreated patients with HER2-positive metastatic breast cancer.
Mylan NV asked U.S. regulators earlier this month to
approve its own biosimilar form of Herceptin, being developed
with India's Biocon Ltd, after it was shown to be
similarly safe and effective as Roche's drug in a large
Amgen Inc and partner Allergan Plc are also
racing to develop a Herceptin biosimilar, which has showed it is
comparable with the branded version in a late-stage trial.
Herceptin, which is also used to treat gastric cancer,
generated global sales of more than $6.5 billion in 2015, making
it one of Roche's top products.
Biosimilars are not expected to become available for at
least another year or two in the United States. The U.S. patent
on Herceptin is slated to lapse in 2019, although some industry
analysts believe a biosimilar could be launched as soon as 2018.
Pfizer's stock little changed in early trading on Wednesday.
(Reporting by Natalie Grover in Bengaluru and Ransdell Pierson
in New York; Editing by Saumyadeb Chakrabarty)