US Biosimilar Launches About to Turn a Corner

Regulatory NewsRegulatory News | 16 March 2020 |  By 

The US biosimilar industry has lingered in the shadow of the European market since the US pathway for approvals was initiated in 2009.

Ten years later (or less than five years since the first FDA approval of a biosimilar), and just 46% (12 out of 26) of FDA-approved biosimilars have launched. But in the next three months (see chart below), a clutch of new biosimilars will hit the market, including new ones in oncology, hinting at a wave of uptake.

For instance, Pfizer is expected to launch three biosimilars soon: one for Avastin (bevacizumab) later this month, one for Rituxan (rituximab) next month, and one in February for Herceptin (trastuzumab). Two other trastuzumab biosimilars may also launch soon, which would mean more than 60% of biosimilars approved in the US will have launched by early next year.

The rising number of launches, combined with an increasing amount of quick uptake, may put biosimilar foes on their heels.

For instance, Neulasta (pegfilgrastim) biosimilars have found recent success, with Coherus’ Udenyca (pegfilgrastim-cbqv) and Mylan and Biocon’s Fulphila (pegfilgrastim-jmdb) capturing 25% market share in just over a year, according to a report released last week from Bernstein.

Similarly, a sign of rapid uptake can be seen with Amgen’s Mvasi (bevacizumab-awwb), which has captured 10% of the Avastin market in just four months.

“Biosimilars are growing their market share and leading to meaningful price erosion over time; with the more recent biosimilar launches showing a lot of success – reflecting perhaps the growing market sophistication of the biosimilar companies,” former FDA Commissioner Scott Gottlieb, referring to the Bernstein report, noted recently.

And in the future, Humira (adalimumab) and Enbrel (etanercept) biosimilars (seven approved, zero launched int he US) may look more like outliers in a larger pool of approvals and subsequent launches. By contrast, in the EU, Humira biosimilars have already captured 35% of the multi-billion-dollar market in one year, and biosimilars have captured 50% of the Enbrel market in about three years, according to Bernstein.

The US Remicade (infliximab) biosimilar market is also an eyesore (Bernstein refers to it as “essentially a failed market”) as the two biosimilar entrants have only amassed 12% market share in more than two years. Amgen’s infliximab biosimilar was recently approved last week and may hit the market soon. And Johnson & Johnson said the Federal Trade Commission has launched an investigation into its contracting practices for Remicade, although similar investigations in Canada and the UK yielded little.

“We should ban anti-competitive rebating” in markets where biosimilars entered, Gottlieb added.
Biosimilars (in order by FDA approval date) Launched in the US?
Zarxio (Filgrastim-sndz) Yes, Sept. 2015
Inflectra (Infliximab-dyyb) Yes, late 2016
Erelzi (Etanercept-szzs) No, launch date unknown
Amjevita (adalimumab-atto) No, coming on 31 January 2023
Renflexis (infliximab-abda) Yes, July 2017
Cyltezo (adalimumab-adbm) No, coming on 1 July 2023
Mvasi (bevacizumab-awwb) Yes, launched in July 2019
Ogivri (trastuzumab-dkst) Yes, launched 2 December 2019
Ixifi (infliximab-qbtx) Not planning to launch
Retacrit (epoetin alfa-epbx) Yes, November 2018
Fulphila (pegfilgrastim-jmdb) Yes, July 2018
Nivestym (filgrastim-aafi) Yes, 1 October 2018
Hyrimoz (adalimumab-adaz) No, coming on 30 September 2023
Truxima (rituximab-abbs) Yes, November 2019
Udenyca (pegfilgrastim-cbqv)  Yes, 3 January 2019
Herzuma (trastuzumab-pkrb)  Yes, launched on 16 March
Ontruzant (trastuzumab-dttb) No, unknown
Trazimera (trastuzumab-qyyp) Yes, launched on 15 February 2020
Eticovo (etanercept-ykro) No, unknown
Kanjinti (trastuzumab-anns)   Yes, launched on July 2019
Zirabev (bevacizumab-bvzr)  Yes, launched on 31 December 2019

Hadlima (adalimumab-bwwd)
No, launching after 30 June 2023
Ruxience (rituximab-pvvr) Yes, launched in January 2020
Abrilada (adalimumab-afzb) No, expects to launch in 2023
Ziextenzo (pegfilgrastim-bmez) Yes, in November 2019
Avsola (infliximab-axxq) No, unknown

Article updated on 3/16/20 with several new launch dates.


© 2022 Regulatory Affairs Professionals Society.

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