Injectable generics specialist and biosimilars maker Hospira announced on 16 February 2015 that it was launching its infliximab biosimilar, Inflectra, in several major European markets. Inflectra, a treatment for inflammatory diseases such as rheumatoid arthritis and inflammatory bowel disease, will now be marketed in 24 European countries, nearly doubling its presence across Europe.
Inflectra is already sold in Central and Eastern Europe and a number of other Western European countries where patents on the reference product have expired. It will soon be available in Austria, Sweden, Denmark, France, Germany, Greece, Italy, Luxembourg, The Netherlands and Spain.
Inflectra was the first biosimilar monoclonal antibody to be approved in Europe [1] and should provide a more affordable treatment option for patients suffering from a range of severe, debilitating inflammatory diseases. Hospira’s announcement was welcomed by Australia’s Generic Medicines Industry Association (GMiA). ‘The savings expected to be generated from biosimilars can provide an opportunity to improve patient access to life-changing medications’ said GMiA CEO, Ms Belinda Wood, ‘And this is a great sign for Australian patients. As the Therapeutic Goods Administration looks to Europe for guidance on biosimilar regulation’.
In its announcement, Hospira quoted data published in GaBI Journal suggesting that savings generated by introducing competition in the marketplace could save the European healthcare system millions of Euros, with biosimilars expected to produce savings of over Euros 20 billion by 2020 [2]. The savings to be made, however, remain far from clear, since they will depend on a combination of regulatory issues, whether physicians will accept biosimilars and pricing and reimbursement policies [3].
The news of Inflectra’s increased availability across Europe came just as FDA’s Arthritis Advisory Committee is preparing to consider Celltrion’s biosimilar infliximab application [4].
Pharma giant Pfizer announced in February 2015 that it is to buy Hospira for US$17 billion. The products acquired in the deal will be integrated into Pfizer’s generics unit, Global Established Pharmaceutical (GEP), which is widely thought to being prepared for a potential spin-off. If this were to happen, GEP would become the largest developer of biosimilars and generics by 2018 [5].
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References
1. GaBI Online - Generics and Biosimilars Initiative. EC approves first monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 6]. Available from: www.gabionline.net/Biosimilars/News/EC-approves-first-monoclonal-antibody-biosimilar
2. Haustein R, et al. Saving money in the European healthcare systems with biosimilars. Generics and Biosimilars Initiative Journal (GaBI Journal). 2012;1(3-4):120-6. doi:10.5639/gabij.2012.0103-4.036
3. Perks B. Weighing up the cost of switching to biosimilars. Generics and Biosimilars Initiative Journal (GaBI Journal). 2014;3(42):100. doi:10.5639/gabij.2014.0302.025
4. GaBI Online - Generics and Biosimilars Initiative. FDA advisers to consider infliximab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 6]. Available from: www.gabionline.net/Biosimilars/News/FDA-advisers-to-consider-infliximab-biosimilar
5. 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 Mar 6]. Available from: www.gabionline.net/Pharma-News/Pfizer-sets-to-lead-biosimilars-and-generics-markets
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