The drug in question is a version of Enbrel (etanercept), an anti-tumour necrosis factor antibody used to treat autoimmune disorders including rheumatoid arthritis and psoriasis.
Sandoz is seeking approval via the 351(k) pathway, which is the route through which it gained regulatory clearance for its Neupogen biosimilar Zarxio (filgrastim-sndz).
The Novartis unit's submission includes data from a pharmacokinetic study in healthy volunteers and a confirmatory efficacy trial – codenamed EGALITY – in people with chronic plaque-type psoriasis.
Sandoz is seeking US approval for the as yet unnamed drug as a biosimilar, rather than as an interchangeable biosimilar, which is the same strategy it followed for Zarxio.
CHO cell
The US FDA can designate a biosimilar as “interchangeable” – meaning pharmacists can dispense it instead of the originator (in States where the practice is allowed) – if the sponsor can prove it is “expected to produce the same clinical result as the reference product.”
Sandoz did not say why it had not sought interchangable status when asked, telling us instead that: “We cannot comment on our plans at this time" adding that "there has been no official guidance from FDA on this topic.
The firm declined to name the drug in question for competitive reasons, but did confirm that, if approved, it will be made at facilities in Austria and Slovenia using a Chinese Hamster Ovarian (CHO) cell-line based system.
Novartis recently announced it was investing €150m ($167m) to increase fill finish capacity at the Austrian site, telling us the expansion will support the production of biosimilars and branded biologics.
Sandoz expects the US agency to reach a decision about the drug within 10 months as per its standard review procedures.
Legal battle
The Zarxio launch was only possible after various legal challenges brought by Amgen failed in the US Courts.
Amgen's effort to block Zarxio in the US just a few weeks after the FDA accepted it for review in July 2014.
The US biotech's main effort was a lawsuit that accused Sandoz of failing to provide it with a full description of the processes used to make the drug.