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.Biolink.us

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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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