With the first biosimilar approved in the US, pharmaceutical companies are scrambling to bring the next to market. Which company is in the lead?

1. Who’s Leading the
Biosimilars Race?
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With the first biosimilar approved in the US,
pharmaceutical companies are scrambling to
bring the next to market.
US biopharma giants, Pfizer and Amgen, along
with South Korea’s Celltrion and Swiss based
Novartis are emerging as frontrunners in the
biosimilars race.
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Celltrion has led the pack until now, with seven
molecules in the development stage, plus
biosimilars of Humira, Rituxan, Herceptin and
Avastin already in clinical trials through its pre-
existing agreement with biosimilar innovator
Hospira. It’s also pushing for FDA approval of
its copy of Johnson & Johnson/Merck’s
rheumatoid arthritis drug, Remicade, which it
currently sells in Europe as Remsima. Celltrion
hopes to launch it on the US market later this
year, under the name, Inflectra.
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However, Pfizer’s $17 billion acquisition of
Hospira in February may present another
hurdle for Celltrion, with Hospira’s five
biosimilars in development bumping up Pfizer’s
stable to ten.
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Amgen took the first hit to its market position
when Sandoz/Novartis copied its originator,
Neupogen with Zarxio. Sandoz is also seeking
FDA approval of another two Amgen drugs,
Neulasta, which like Zarxio boosts white blood
cell counts, and Enbrel, another rheumatoid
arthritis drug. Pfizer/Hospira has been circling,
with Retatcrit, its version of Amgen's anemia
biologic, Epogen. Available in Europe since
2008, it is currently awaiting FDA approval.
This adds up to almost $11 billion worth of US
sales for Amgen’s four originator biologics in
2014, according to the company’s financial
statements
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But Amgen is showing plenty of fight for
market share. Working on nine biosimilar
copies of competitors' drugs, it aims to get the
first to market by 2017 and another four by
2019. That’s estimated at a combined $52
billion worth of sales according to last year’s
figures.
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Amgen, Pfizer, Novartis, and Celltrion are
wisely playing both sides of field – capitalizing
on the new biosimilars market, while
continuing to develop original biologics. And
with such a tightly-run race, it will be
interesting to see who comes out on top by
year’s end.
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