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Amgen, Hospira and Sandoz set to dominate US biosimilars market Posted 31/05/2013

A new report released by Thomson Reuters on 14 May 2013 identifies Amgen, Hospira and Sandoz as having the greatest potential to dominate the early stages of the biosimilars market in the US.

Amgen
Biotech giant Amgen will be able to gain a competitive advantage due to having access to marketing budgets and experience gained through their novel biological drug programmes. At its investor meeting in February 2013, Amgen also outlined plans to launch a portfolio of six new biosimilars (four cancer drugs and two for inflammatory diseases) beginning in 2017 [1]. The portfolio will include biosimilar versions of Avastin (bevacizumab), Herceptin (trastuzumab), Rituxan (rituximab) and Erbitux (cetuximab).

Amgen’s partnership with Actavis to develop biosimilars is also expected to strengthen its position, bringing together the strong brand recognition and biological market establishment of Amgen with the generics market understanding and savvy of Actavis.

Actavis’ record in patent challenges may also help to advance the partnership in the US biosimilars market. Actavis comes in only second after Teva in the number of patent challenges in the US.

Hospira
Injectable generics specialist Hospira is currently conducting global clinical trials for biosimilar candidates. The company already sells a biosimilar erythropoietin (Retacrit) in Europe and has launched a biosimilar version of filgrastim (Nivestim) in Australia [2]. Hospira’s biosimilar market experience in the EU and Australia, as well as its global experience with generics, is expected to give the company a competitive advantage over companies that have only launched in less regulated markets.

The company has biosimilars agreements in place with Celltrion, Human Genome Sciences, NovaQuest Co-Investment Fund and Stada [3]. The combination of Hospira’s market experience and Celltrion’s capability makes the partnership one of the strongest for US competition.

Hospira has already carried out a successful phase I trial for biosimilar erythropoietin in the US comparing it to Amgen’s blockbuster anaemia drug, Epogen (epoetin alpha) [4]; and it is currently conducting a phase III US clinical trial programme [5]. Hospira’s biosimilars pipeline (including products it shares with Celltrion) includes 11 products.

Sandoz
Novartis generics unit Sandoz has been a pioneer in biosimilar competitions and is expected to be an early entrant in the US market.

Sandoz already has a product, Omnitrope (somatropin) approved in the US, which is considered a biosimilar in other regulated markets. The company is a leader in the EU biosimilars market, being the only company to have more than two approved biosimilars. Sandoz is currently conducting phase III trials for US approval of filgrastim and pegfilgrastim biosimilars.

Like Hospira, Sandoz’s biosimilar market experience in the EU, as well as its global experience with generics, is expected to give the company a competitive advantage over companies that have only launched in less regulated markets.

The experience of Sandoz’s parent company, Novartis, in patent challenges may also help to advance Sandoz in the US biosimilars market. Novartis comes in fourth in the league table of patent challenges in the US.

A phase III trial of Sandoz’s biosimilar rituximab (GP-2013) in the treatment of patients with previously untreated, advanced stage follicular lymphoma began at the start of 2012 and is estimated to be completed at the end of the first quarter 2014. In October 2012, Sandoz also started a phase III trial for its biosimilar epoetin alpha in the US [6] and is also carrying out trials with biosimilar filgrastim and pegfilgrastim [7].

Other companies expected to launch biosimilars in the US include Biocon, Celltrion, Merck, Roche and Teva Pharmaceutical Industries.

Related article

Biosimilars and US exclusivity

Reference

1.  GaBI Online - Generics and Biosimilars Initiative. Amgen’s biosimilar plans [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 May 31]. Available from: www.gabionline.net/Biosimilars/News/Amgen-s-biosimilar-plans

2.  GaBI Online - Generics and Biosimilars Initiative. Hospira looks to biosimilars and increased use of generics for growth [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 May 31]. Available from: www.gabionline.net/Biosimilars/News/Hospira-looks-to-biosimilars-and-increased-use-of-generics-for-growth

3.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars agreements for Hospira and mAbxience [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 May 31]. Available from: www.gabionline.net/Biosimilars/News/Biosimilars-agreements-for-Hospira-and-mAbxience

4.  GaBI Online - Generics and Biosimilars Initiative. Positive results for phase I trial of biosimilar erythropoietin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 May 31]. Available from: www.gabionline.net/Biosimilars/News/Positive-results-for-phase-I-trial-of-biosimilar-erythropoietin

5.  GaBI Online - Generics and Biosimilars Initiative. Hospira marks five years of biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 May 31]. Available from: www.gabionline.net/Biosimilars/News/Hospira-marks-five-years-of-biosimilars

6.  GaBI Online - Generics and Biosimilars Initiative. Sandoz starts phase III US trial for biosimilar epoetin alfa [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 May 31]. Available from: www.gabionline.net/Biosimilars/Research/Sandoz-starts-phase-III-US-trial-for-biosimilar-epoetin-alfa

7.  GaBI Online - Generics and Biosimilars Initiative. Sandoz starts phase III trials for biosimilar filgrastim and pegfilgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 May 31]. Available from: www.gabionline.net/Biosimilars/News/Sandoz-starts-phase-III-trials-for-biosimilar-filgrastim-and-pegfilgrastim

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Source: Reuters

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