FDA should expect more submissions as US biosimilar doors open, says consultant

By Dan Stanton contact

- Last updated on GMT

Recent regulatory recommendation was inevitable step in opening doors for biosimilars in the US
Recent regulatory recommendation was inevitable step in opening doors for biosimilars in the US

Related tags: Food and drug administration

Sandoz’s recommendation was an “inevitable step” in the introduction of biosimilars to the US, and the US FDA should expect more submissions according to a consultant.

Earlier this month​, the FDA’s Oncologic Drugs Advisory Committee (ODAC) concluded there was no clinically meaningful difference between Sandoz’ Zarxio and the reference biologic, Amgen’s Neupogen.

Within a week​, biosimilar developer Hospira announced its version of Amgen’s Epogen had been submitted for review.

“The unanimous recommendation by the FDA advisory committee for Sandoz’ biosimilar Neupogen is certainly a milestone in the development of biosimilars in the US,”​ Howard Levine, President of BioProcess Technology Consultants, told Biopharma-Reporter.com. “I am sure this will be followed by several other announcements similar to Hospira’s regarding filings for other biosimilars.”

So far just four drugmakers have said publically their biosimilars have been accepted for review by the FDA. On top of the Sandoz and Hospira announcement, Celltrion submitted its version of Janssen’s monoclonal antibody drug Remsima (infliximab) in August last year, and in December Apotex​ filed its copy of Amgen’s Neulasta (filgrastim).

Opening Doors

But companies have been lining up to develop these products in the US even before the Biologics Price Competition and Innovation Act (​BPCI) was passed in 2009, Levine said.

“FDA now reports the number of biosimilar INDs filed​ and we estimate that there are currently at least 15 open INDs for various biosimilars in the US,”​ he said. “So, I don’t necessarily consider the advisory panel recommendation an opening of the floodgates but rather an inevitable step in the ultimate introduction of biosimilars in the US.”

The dedicated 351(k) biosimilar approval pathway involves the FDA meeting with biosimilar makers before an IND is filed, during biosimilar product development (BPD) and before a Biologic License Application (BLA) is decided.

A presentation​ by Steven Kozlowski, Director at the FDA’s Office of Biotechnology Products, at the FDA/PQRI Conference on Evolving Quality in September last year revealed the agency had received, to date, 76 meeting requests for proposed biosimilars and had held 59 initial sponsor meetings.

These figures were up 52% and 59% respectively from figures announced by Commissioner Margaret Hamburg in February 2013, at the Annual Meeting Generic Pharmaceutical Manufacturers Association​.

Fine line for Amgen

Three of the four known submissions reference Amgen’s proprietary products and in a statement sent to this publication the firm said:

“Amgen, as a developer of both innovative biologics and biosimilars, supports a science-based, patient-centric, regulatory framework for all biosimilars.  High-quality, reliably supplied biosimilars have the potential to offer additional choices to patients and other key stakeholders.”

According to Levine, the Big Biopharma company is “clearly walking a fine line between protecting their original products and keeping the door open for their biosimilar products.”

“I expect that we will see reference product holders who also have biosimilar programs responding similarly to Amgen. Those that do not have internal biosimilar programs will probably be a bit more forceful in continuing to fight the introduction of biosimilars in the US,” ​he added.

 “I think the next couple of years will be very telling as more products come off patent and many of the biosimilars currently in clinical trials reach the point where the developers file for market approval.”

Related topics: Markets & Regulations, Biosimilars

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