Industry News

FDA approves first biosimilar product Zarxio / biosimilar to Amgen Inc.’s Neupogen (filgrastim)

The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States. Biological products are generally derived from a living organism. They can come from many sources, including humans, animals, microorganisms or yeast. A biosimilar product is a biological product that is approved based on a showing that … Continued

Industry News

Tufts: biosimilars will not be an instant hit

Eli Lilly’s Lantus biosimilar is waiting to edge into the US market, Hospira is developing a lookalike for Roche’s Lucentis, and an FDA panel endorsed a biosimilar of Amgen’s Neupogen, but a study by the Tufts Center for the Study of Drug Development indicates it is going to take some time before biosimilars unseat branded … Continued

Industry News

Biosimilar Filgrastim Recommended for Approval in US

A biosimilar version of filgrastim (EP2006, Sandoz/Novartis) has today been recommended for approval in the United States.   The new product is like a generic version of the brand-name filgrastim, marketed as Neupogen (Amgen), which had sales of more than $1 billion in 2014. However, “generic” is the term used when the drug is a … Continued

Industry News

FDA Accepts Sandoz Application for Biosimilar Filgrastim

Sandoz, a Novartis Group company, has announced that FDA has accepted its Biologics Licence Application for filgrastim, which was filed under the new biosimilar pathway created in the Biologics Price Competition and Innovation Act of 2009 (BPCIA). The reference product — Amgen’s Neupogen — is indicated to decrease the incidence of infection, as manifested by … Continued

Industry News

CDER SBIA Chronicles: GDUFA Where Are We Now?

The topic of this month’s issue of the FDA/CDER Small Business Chronicles: GDUFA Where Are We Now? (pdf) The Generic Drug User Fee Amendments of 2012 (GDUFA) had some challenging goals when it was first introduced in September 2012. By September 30, 2017, GDUFA requires FDA to review and act on 90 percent of complete electronic … Continued

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The U.S.P.T.O. issued guidelines to its Patent Examining Corps

On March 4, 2014, the U.S.P.T.O. issued guidelines to its Patent Examining Corps for determining whether inventions are eligible for patenting under 35 U.S.C. § 101 or ineligible under the judicially created exceptions from eligibility for laws of nature, natural phenomena, or natural products.  (Previously established guidelines will continue to be followed for analyzing whether the abstract ideas … Continued

Industry News

FDA FY2013 GDUFA Performance Report

FDA has met all GDUFA program commitments for FY2013 and laid the foundation for future success. We are committed to meeting all GDUFA performance goals while, as always, maintaining a focus on ensuring that safe, effective, and affordable human generic drugs are reviewed in an efficient and predictable time frame. FDA has presented the fiscal … Continued

Industry News

FDA – GDUFA Accomplishments

As the Generic Drug User Fee Amendments of 2012 (GDUFA) approaches the first anniversary of its enactment, the program has achieved a number of significant milestones. The program, designed to speed access to safe and effective generic drugs by supplementing federal funds with industry user fees, has: Made significant strides in reducing the backlog of … Continued

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Remicade knockoff delivers pioneering antibody biosimilar OK for Hospira, Celltrion

The antibody knockoffs are coming–gradually. Today the European Commission made healthcare history with its first approval of a biosimilar antibody–Inflectra (infliximab)–which was developed by Korea’s Celltrion and will be sold by generics powerhouse Hospira ($HSP). But the companies don’t expect to file for U.S. approval until 2015 as they wait for the FDA to finalize … Continued

Industry News

Biosimilar bill passed by California Assembly

The biosimilar market is a rapidly-growing segment of the pharmaceutical industry, but the US is still in the early stages of developing biosimilar regulation. In recent months, several US states have been contemplating passing bills on biosimilar drug use, and the California Assembly is thelatest to pass such a bill. The Californian legislation would require … Continued