Apotex has recently made news in Canada, introducing biosimilars and obtaining marketshare there. However, the story of Apotex and its Apobiologix biosimilar subsidiary in the US is less positive.
As we’ve listed in our updated table, Apotex had originally
filed for approval for its pegfilgrastim biosimilar with the FDA in late 2014
and its filgrastim biosimilar in early 2015. In 2019, no announcement has been
made with regard to the filing status of either biosimilar.
In April 2018, we spoke with Apobiologix executives, who told us that the company “were still in discussions with the FDA” about the path forward for its G-CSF biosimilars. Unfortunately, this statement has not changed at all on its website. If there were discussions, they didn’t go far. And so the mystery continues.
There is some support for the view that the parent company is
seeking to shed the Apobiologix subsidiary, and has been actively seeking a
buyer for some time. This would make sense to a degree, as any of its newly approved
biosimilars would be facing a difficult crawl to US marketshare, being the
third or fourth filgrastim or pegfilgrastim biosimilar to launch. Realizing that its marketshare potential would
be substantially limited, why spend the additional developmental dollars?
In April 2018, Canada had granted the company approval to market its pegfilgrastim biosimilar (Lapelga™), and in Canada’s provincial systems, it has become a dominant player. Filgrastim was approved in Canada in 2016 (and in the EU in 2014).
According to its website, Apobiologix had been developing
the following products for the US market:
- Epoetin alfa (reference drug, Epogen®),
in Phase 3
- Darbepoetin alfa (Aranesp®), in preclinical
- Bevacizumab (Avastin®), in Phase 1
- Rituximab (Rituxan®), in Phase 1
- Trastuzumab (Herceptin®), in preclinical
Although the pipeline lists the epoetin, bevacizumab, and
rituximab biosimilars in clinical trials, no mention of any of these specific
investigations can be found on www.clinicaltrials.gov, under
Apotex or Apobiologix as a sponsor. A request for comment from Apobiologix was
not answered by the time of this publication.
If this is the case, it is less the FDA than the parent drug maker who has lost faith in their biosimilars’ potential in the US. We can ill afford fewer active players in this market.