by Angela Maas
So far, biosimilar uptake has been relatively slow in the U.S.
since the 2015 launch of Sandoz Inc.’s Zarxio (filgrastim-sndz), the first
product to use the 351(k) approval pathway. But recent and pending launches
have resulted in therapeutic classes with more than one biosimilar, which may
be the push that payers need to begin preferring them over their reference
products and, in turn, realizing savings in some costly therapeutic classes.
Although the FDA had approved 26 biosimilars as of the end of
January, only half of them are available in the U.S., with many of the
drugmakers tied up in patent litigation with reference drug manufacturers.
2019 saw the launch of the first oncology biosimilars when Amgen
and Allergan plc launched Kanjinti (trastuzumab-anns), a Herceptin
(trastuzumab) biosimilar, and Mvasi (bevacizumab-awwb), an Avastin
(bevacizumab) biosimilar, on July 18. Both reference drugs are from Genentech
USA, Inc., a Roche Group unit. Then, on Nov. 7, Teva Pharmaceuticals USA, Inc.
and Celltrion launched Truxima (rituximab-abbs), with reference drug Rituxan
(rituximab) from Genentech and Biogen.
The Dec. 2 launch of Mylan N.V. and Biocon Ltd.’s Ogivri
(trastuzumab-dkst) brought a second biosimilar of Herceptin onto the U.S.
market, with a third — Pfizer’s Trazimera (trastuzumab-qyyp) — expected Feb.
15. Also expected to launch in the first part of this year are Ontruzant
(trastuzumab-dttb) from Samsung Bioepis Co., Ltd. and Herzuma (trastuzumab-pkrb)
from Celltrion and Teva.
A second Avastin biosimilar came onto the U.S. market Dec. 31
when Pfizer launched Zirabev (bevacizumab-bvzr). Rituxan also had additional
biosimilar competition on Jan. 23 when Pfizer’s Ruxience (rituximab-pvvr) launched.
Kanjinti is priced 15% less than Herceptin, and its average
sales price (ASP) is 13% below the reference drug. Ogivri’s price is "at a
competitive discount," according to Mylan and Biocon. Mvasi is priced 15%
less than Avastin, and its ASP is 12% less than that of the reference drug.
Zirabev is priced 23% less than Avastin, and Ruxience is 24% less than Rituxan.
"As more health plans set biosimilars on a preferred
status, adoption and utilization should increase,” says Martin Burruano, R.Ph.,
vice president, pharmacy services at Independent Health. "As more become
available, there will be opportunity to plan formulary selection to drive costs
down. Projections are modest at 12%-15% cost savings initially but will
potentially reach 70% cost savings in five years."
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