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BiologicsHQ Search

Information contained in the Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book. Product and Company page search results are reported for FDA-approved indications, aBLA activity, approved foreign biosimilars, IPRs and U.S. litigations.

Biologics Team

More than 70 of our attorneys have degrees in disciplines such as immunology, biochemistry, molecular biology, biotechnology, biomedical engineering, molecular pharmacology, genetics, biology, and chemistry.

The U.S. Biosimilars Market is Heating Up: Guidance from the Federal Circuit is Expected Late Spring

It has been five years to the month since the Biologics Price Competition and Innovation Act (“BPCIA”) was signed into law, and March 2015 was the busiest month to date for the emerging U.S. biosimilars market. Currently worth approximately $1 billion a year worldwide, reports predict that this market will be worth at least $20 billion a year by 2020. This provides a strong incentive for companies like Sandoz, Celltrion, Hospira, Eli Lilly, Teva, Apotex, Accord, Ratiopharm, and others who currently market the 19 biosimilar drugs that are on sale in Europe, to seek approval in the lucrative U.S. market. read more

The FDA Approves Zarxio Opening the Door to the U.S. Biosimilars Market

March 6, 2015 was a turning point for the emerging U.S. biosimilars market. The U.S. Food and Drug Administration (FDA) approved Sandoz’s application to market Zarxio®, the first biosimilar drug in the U.S. Zarxio® (approved as “filgrastim-sndz”) is a biosimilar of Amgen’s Neupogen®, a drug with 2013 sales of $1.4bn. Zarxio® is currently on the market in Europe (as Zarzio®), and is now approved in the U.S. as a 0.5 ml and a 0.8 ml injectable for all five of the indications on the Neupogen® label, including the treatment of patients with various cancers, and the treatment of patients with various forms of neutropenia (white blood cell disorders). read more

METHODOLOGY

Information contained in the Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book. Information relating to FDA licensed products, FDA-approved indications and aBLA applications is obtained from public sources including the U.S. FDA website (www.fda. gov). Information relating to foreign biosimilar / biologics followon products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics Graphics are compiled from information contained in the Fitzpatrick BiologicsHQ database.

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