The US Federal Trade Commission (FTC) has approved Pfizer’s $17 billion acquisition of Hospira, subject to divestment of four US sterile injectable assets. The approval paves the way for the deal to be completed by early September.

The FTC terminated the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, with respect to Pfizer's pending acquisition of Hospira. The FTC's clearance is contingent upon Pfizer's commitment to divest four US sterile injectable assets, including acetylcysteine, clindamycin, voriconazole, and melphalan.

In addition, Pfizer announced that Brazil's Superintendency-General of CADE has published its unconditional clearance decision.

The approval from US and Brazilian regulatory authorities mark the final needed approvals for Pfizer to proceed with its acquisition of Hospira. Earlier this month, Pfizer was granted approval from the Canadian Competition Bureau for the pending acquisition, subject to certain divestments, and also received approval from the Australian Competition and Consumer Commission with no requests for divestments. The Canadian Competition Bureau reached an agreement with Pfizer under which Pfizer will sell its Canadian assets related to its marketed injectable cytarabine products (used to treat various types of blood cancers), injectable epirubicin products (used to treat a variety of cancerous tumor types), and oral tablet methotrexate products (used to treat certain cancers as well as severe psoriasis and arthritis), as well as Hospira's pipeline injectable voriconazole product (used to treat serious, invasive fungal infections).

Approval from the regulatory authorities of Canada and Australia followed approval by the European Commission (EC) also earlier this month, pending certain divestments. The EC approval is conditional on Pfizer divesting certain sterile injectable drugs as well as its infliximab biosimilar drug, which is currently under development. Infliximab is the active ingredient in Johnson & Johnson’s Remicade, a drug used o treat autoimmune diseases such as rheumatoid arthritis and Crohn’s disease.

In its ruling, the EC noted that one biosimilar has been approved for use in the European Economic Area (EEA) (developed by Celltrion but co-marketed by Hospira and Celltrion), and that two companies have biosimilars in advanced stages of development (Samsung Bioepis and Pfizer). The EC said it had competition concerns for infliximab drugs because following the merger with Hospira, Pfizer would be likely to either: delay or discontinue development of its biosimilar drug in order 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 hand back Hospira’s product to its developer Celltrion, leading to the loss of current price competition between Hospira and Celltrion.

The EC also noted competition concerns for sterile injectables for certain products in some European Union (EU) 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). To address these competition concerns, Pfizer submitted a set of commitments and following a review and has agreed to the following: (1) full divestment of the development, manufacturing and marketing rights of its infliximab biosimilar drug currently under development (including appropriate intellectual property, technology and know-how), with marketing rights outside the EEA remaining with the merging entity and (2) divestment of marketing authorizations and associated rights of Pfizer or Hospira in relation to certain sterile injectables relevant in specified EU countries.

Source: Pfizer