An emerging theme of 2015 is the debuts of biosimilars in the world’s biggest drug market, and the South Korean group Celltrion figures to be front and centre in that push. Its Hospira-partnered Remicade lookalike Remsima is due an FDA decision in August, just months after the agency is to make its first ever pronouncement on a biosimilar.
If Europe is any indication, changing physician perceptions about biosimilars will be vital to the launch outlook, and Celltrion Healthcare's president Stanley Hong says what has worked for his company is to show them the science behind the drug. “They see the analytical method and manufacturing process is well advanced,” he tells EP Vantage. “Because of our advanced assay technology we could successfully show the similarity and comparability of even the oligosaccharide structure in great detail.”
Partners, friendly rivals
Approval in the US will present a slightly simpler launch prospect for Celltrion and Hospira. European rollout has been gradual as market exclusivity has expired at different times throughout the common market, with the big markets of France, Germany, Italy and Spain seeing first introduction just two weeks ago.
What is more, the 2009 licensing deal between the two parties allows each to market the Remicade biosimilar separately under different names in some countries – Inflectra for Hospira and Remsima for Celltrion's other Euorpean partners. While this is uncommon in the pharma sector, Mr Hong says it could help both companies: “The advantage is, through healthy competition in the same territory, they can increase the total size of the sales.” But he adds: “The disadvantage is that they compete with each other.”
This will be a moot point in the US, where a single patent expiry – a 2018 date is under judicial challenge from Celltrion – will enable an immediate national rollout. And because of an amendment signed last year Hospira now has exclusive rights to the Remicade biosimilar along with a Herceptin copy in the US, Canada, Mexico and Brazil.
Mr Hong would not disclose the financial terms of either the original 2009 pact or the 2014 amendment.
An advisory committee was recently called and then postponed for the US Remsima application, with the FDA stating that the delay was due to “information requests pending with the sponsor”. Mr Hong would not reveal more about the postponement, other than to call it “the normal process”.
Pfizer’s $17bn move on Celltrion’s main partner could also be taken as a sign that biosimilars’ time has come (Hospira moves the needle for Pfizer spin-out, February 5, 2015). Pfizer has already signalled its intent in this space by developing its own portfolio, and acquiring Hospira allows the big pharma to buy its way closer to the market.
The trouble is duplication in the pipeline, as Pfizer already has its own Remicade and Herceptin projects (With FDA action nearing biosimilar agents begin to shake US market, Februay 16, 2015). When it announced the transaction, Pfizer spoke positively about the Hospira biosimilars business, but its strategy regarding the duplication probably will not become clear until after its close later this year.
For his part, Mr Hong said the Celltrion partnership was business as usual: “We keep communicating with Hospira about the ongoing relationship. I don’t know what Pfizer’s plan is.”
The immediate future holds news for Celltrion about two late-stage products which Mr Hong would not name, but that are being aimed at the EU for now.
Approval of the first US biosimilar – set to be Novartis's Zarxio by the end of March – will perhaps make the regulatory pathway more straightforward, but Mr Hong predicts that it will not make things any easier for Celltrion, Hospira or any other company now active in this space.
Regulators “have a clear picture of the process, so if there are any problems with the other following products then they will easily and swiftly and confidently reject. If the quality of the following products is good, I think they can approve.”