The FTC’s clearance is, however, conditional and depends upon Pfizer’s commitment to divest four US sterile injectable products, including acetylcysteine, clindamycin, voriconazole and melphalan.

Pfizer also announced that it had received unconditional clearance from Brazil’s Superintendency-General of the Council for Economic Defence (Conselho Administrativo de Defesa Econômica, CADE).

Hospira’s products are expected to be integrated into Pfizer’s generics unit, Global Established Products (GEP). It is widely thought that the GEP is being prepared for a potential spinoff. Following which, the GEP would become the largest developer of biosimilars and generics by 2018 [1].

Hospira had an infliximab biosimilar (Inflextra) approved by the European Medicines Agency in 2013, a filgrastim biosimilar (Nivestim) approved in 2010 and an epoetin zeta biosimilar (Retacrit) approved in 2007 [2]. The company recently submitted an application to the US Food and Drug Administration for an epoetin alfa biosimilar [3]. Hospira is reportedly developing biosimilars for 11 biologicals, targeting an opportunity of US$40 billion.

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Pfizer sets to lead biosimilars and generics markets

References
1. GaBI Online - Generics and Biosimilars Initiative. Pfizer sets to lead biosimilars and generics markets [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 4]. Available from: www.gabionline.net/Pharma-News/Pfizer-sets-to-lead-biosimilars-and-generics-markets
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 4]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. Hospira submits application to FDA for epoetin alfa biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 4]. Available from: www.gabionline.net/Biosimilars/News/Hospira-submits-application-to-FDA-for-epoetin-alfa-biosimilar

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