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Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.
European Union regulators said Pfizer must divest its infliximab biosimilar candidate and some sterile injectables for the merger with Hospira to be completely approved.
The European Commission announced on Aug. 4, 2015 that it will approve the merger between Pfizer and Hospira, provided that Pfizer divests its biosimilar candidate for infliximab (brand name Remicade), along with some selected sterile injectables. The commission is concerned that the combined company would have “overlapping interests” when it comes to biosimilars for Remicade. Hospira’s Inflectra, an infliximab biosimilar, is already approved and on the market in many geographic regions within Europe, prompting European officials to question whether Pfizer would continue to devote resources to the development of its infliximab product currently in development. If Pfizer did not decide to pursue further development of its infliximab candidate following the merger with Hospira, there would be fewer competitors for the product in the market, which could lead to higher prices and restricted product access.
Because infliximab is one of the top three best-selling drugs on a global scale, according to a EC press release, without a divestiture, the merger would “lead to the net loss of future competition by one of only three differentiated biosimilars in advanced stages of development,” which includes Hospira and Celltrion’s Inflectra and Samsung Bioepis and Merck’s candidate, SB4. The EC said the merger could also lead to a loss in price competition between Hospira and Celltrion if Pfizer were to give the project back to Celltrion.
The EC also said Pfizer will have to divest some injectable chemotherapy assets in certain markets because of the “high combined market shares” that Pfizer and Hospira would have in these areas following the merger. The drugs that would be divestiture targets include carboplatin in Belgium; cytarabine in Belgium, Italy, Portugal, and Sweden; epirubicin in Austria, Belgium, Italy, the Netherlands, and Spain; irinotecan in Belgium, the Czech Republic, and Italy; vancomycin in Ireland; and voriconazole across Europe. Outside of the listed countries, it appears that Pfizer may be able to still market the aforementioned products.
Although the merger is expected to close in the second half of 2015, completion of the transaction will still be subject to governmental and regulatory approvals in certain other jurisdictions, said Pfizer. An FDA advisory panel delayed its meeting on Celltrion and Hospira’s infliximab in early 2015 “due to information requests pending with the sponsor of the application.”
Source: European Commission