“At this point, we’re considering our options, but have nothing to announce,” a Pfizer spokeswoman said when asked if the company had made any progress finding a suitor for the product.
Ronny Gal, senior healthcare analyst with Sanford Bernstein, said a number of companies might enter the fray. “The bidding is just starting,” Gal said in response to an email inquiry last week. “I expect (Fresenius) Kabi, Teva, Hikma, Mylan and Allergan as potential bidders.”
Other analysts see Novartis stepping into the competition. Sandoz, the generic division of Novartis, refers to itself as the “global leader in biosimilars” and has three biosimilars on the market and several more biosimilar molecules in the pipeline. But it lacks biosimilar infliximab.
J&J manufactures the original infliximab biologic, Remicade. Hospira launched its infliximab biosimilar, Inflectra (developed by Celltrion), earlier this year. Another company, Samsung Bioepsis, also has a biosimilar infliximab in development.
The European Commission in early August approved Pfizer’s acquisition of Hospira, on the condition that Pfizer first divest its infliximab candidate and several sterile injectables.
Without infliximab divestiture, the EC said in a press release, Pfizer might delay or discontinue development in order to focus on Hospira’s Inflectra, leading to an uncompetitive market. Or Pfizer might hand Hospira’s infliximab back to developer Celltrion, leading to loss of current price competition between Hospira and Celltrion. Pfizer will be allowed to retain rights to its biosimilar candidate outside the European Economic Area (EEA).
It’s been nearly a month since the EC announced its approval of the deal, and the Pfizer/Hospira merger is expected to close in the second half of the year. Pfizer’s infliximab is in Phase 3 trials.
A recent report by Bidness Etc., a U.S. financial analysis firm, said it makes the most sense for Sandoz to pursue Pfizer’s infliximab.
“Sandoz is already developing all the biosimilars which are expected to be the most successful in the U.S., except the biosimilar version of Remicade,” the report said. “It is likely that Novartis would become interested in acquiring Pfizer’s infliximab biosimilar…to get all the biosimilar drugs which can potentially be the most successful.”
Buying a biosimilar candidate, continuing its development, getting it approved and then succeeding in the market is far more complex than doing the same thing with a small-molecule generic, and that may limit the number of candidates for Pfizer’s infliximab candidate.
“Anyone would have to have experience doing clinical trials, and manufacturing would be a challenge,” said Elan Rubinstein, a pharmaceutical/biotechnology management consultant at EB Rubinstein Associates.
Rubinstein said there are other limits, as well. For instance, a pharmaceutical maker that already sells an originator product might not want to buy a biosimilar version, worried that it could cannibalize sales of the originator. And a company without much biosimilars experience could also be reluctant to make a bid, concerned that it might not have success selling the product.
“If you’re a payer and an unknown maker comes at you with a biosimilar product - and you’re already nervous about the category and whether patients and doctors will accept it - you’re more likely to buy it if it’s a Pfizer or an Amgen rather than an unknown name,” Rubinstein said. “The name factor gives people comfort in this unknown category. That kind of thinking could limit who could take the product.”