Pfizer agrees to divest Infliximab biosimilar plus certain sterile injectable drugs
The European Commission has approved Pfizer's US$17bn acquisition of Hospira, after the US drugmaker agreed to sell its Infliximab biosimilar drug, which is currently under development, as well as certain sterile injectable drugs.
The Commission said the merged entity would have faced insufficient competition, with a risk of price rises and discontinuation of the development of Pfizer's Infliximab biosimilar.
Infliximab is one of the top three best-selling pharmaceuticals globally, originally developed in the 1990s. It is used to treat autoimmune diseases such as rheumatoid arthritis and Crohn's disease. One biosimilar has been approved for use in the European Economic Area (EEA) (developed by Celltrion but co-marketed by Hospira and Celltrion), and two companies have biosimilars in advanced stages of development (Samsung Bioepis and Pfizer).
The EC said competition concerns could arise in the market for Infliximab drugs, because following the merger Pfizer would be likely to either: delay or discontinue development of its biosimilar drug to focus on Hospira's marketed product, leading to the net loss of future competition by one of only three differentiated biosimilars in advanced stages of development (Hospira/Celltrion's, Samsung Bioepis' and Pfizer's); or return Hospira's product to Celltrion, leading to the loss of current price competition between Hospira and Celltrion.
We have made sure that the merger does not stand in the way of the research and development of medication that could have huge benefits for society
Margrethe Vestager, in charge of competition policy at the European Commission, said: 'This is not just about keeping prices low for patients and healthcare services. We have also made sure that the merger of Pfizer/Hospira does not stand in the way of the research and development of medication that could have huge benefits for society.'
Pfizer also agreed to sell certain sterile injectables administered with a hollow hypodermic needle. Most sterile injectables are used as chemotherapies in the treatment of cancer. For these pharmaceuticals, the EC said competition concerns could arise for certain molecules in some Member States (namely 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 in the EEA as a whole), in particular because of the high combined market shares of Pfizer and Hospira and the limited number of competitors that would remain in these markets.
Pfizer's Chairman and CEO Ian Read said: 'We are pleased to have achieved a significant milestone for Pfizer’s pending acquisition of Hospira with the EC’s approval of the transaction.
'We continue to work cooperatively with the regulatory agencies to obtain the requisite approvals, and continue to expect the transaction to close in the second half of 2015.'
Completion of the merger is still subject to approval from other governments and other customary closing conditions.