The FY 2013 biosimilar user fee amounts imply that the president’s budget proposal was accounting for a maximum of 10 marketing applications that year.

It is more likely that there will be fewer than 10 filed however, given that some candidates will reach the product development stage, which also will be charged a fee under the new user fee program.

FDA’s FY 2013 user fees for biosimilars are slated to be published Aug. 1 in the Federal Register.

Biosimilar fees, as per the agency agreement with industry passed by Congress, mirror those for NDAs and BLAs under the Prescription Drug User Fee Act.

The agency also is expected to publish the FY 2013 PDUFA fees Aug. 1.

A biosimilar marketing application requiring clinical data will cost $1.9588 million, according to the Federal Register notice. That means the biosimilar product development fee, which is 10% of the application fee, will be $195,880.

Sponsors will pay the product development fee upon filing a biosimilar IND and each year the product is in development. Those fees were created to provide more revenue early in the program cycle to help pay for FDA review activities. They are subtracted from the price of a marketing application, if it is filed.

FDA did not say in the notice how many applications or INDs it expected to receive in FY 2013. But the administration projected receiving about $20.2 million in biosimilar user fees in its FY 2013 budget request, which was released in February. That would suggest that at most, 10 marketing applications would be expected in the year, assuming no other biosimilar-related filings were received, or as many as 103 IND filings under the same conditions – though the reality should be a blend.

In 2011, the agency appeared to be preparing to deal with as many as 21 applications per year by 2015. It said it wanted to train employees to conduct eight domestic and 13 foreign pre-approval inspections per year Also see "FDA's Budget Path To Biosimilars: 21 Applications By 2015?" - Pink Sheet, 21 February, 2011..

Since the biosimilar program is in its infancy, it is more likely that there will be more product development filings than marketing applications in the first year.

Obama’s budget request, which ended up as a list of priorities for the federal government rather than a spending plan that could be passed, would allocate $40.4 million for the biosimilar program.

Along with the user fee revenue, another $20.2 million would come from the U.S. Treasury. The user fee agreement requires Congress to give at least $20 million in budget authority for biosimilars in order to collect fee revenue from sponsors Also see "Biosimilars, Generic Programs Leave Little Room For Other New FDA Drug Initiatives In FY ‘13" - Pink Sheet, 20 February, 2012..

December Fee Deadline For Sponsors With INDs Already Filed

Sponsors already in discussions with FDA about a biosimilar product will have some time before they must begin paying the biosimilar product development (BPD) fee.

The new fees are effective Oct. 1, when FY 2013 begins, but sponsors that submitted their biosimilar IND before program enactment have until Dec. 1 or within five days of FDA granting the first product development meeting, whichever is sooner, to make their initial BPD fee payment.

In all other cases, the fee is due upon IND submission or within five days of FDA granting the initial BPD meeting, whichever is sooner.

BsUFA became law when Obama signed the FDA Safety and Innovation Act on July 9. The bill created biosimilar and generic drug user fees and reauthorized the prescription drug and medical device fee programs, as well as made some policy changes ([A#00120716007]).

Given the early interest in biosimilars that FDA has revealed, there could be a significant amount of BPD revenue collected early in the fiscal year.

FDA has said for several months that even though there is no available user fee revenue or much guidance on biosimilars, it will talk to potential sponsors about applications.

In December, the agency said it had received 31 pre-IND meeting requests related to 11 products. At that time, it had also opened seven biosimilar IND development programs and held 21 pre-IND sponsor meetings Also see "Biosimilar User Fee Agreement Allows For Reliance On Foreign Clinical Data, FDAer Says" - Pink Sheet, 14 December, 2011..

FDA Continues Working On Interchangeability And Other Issues

Biosimilar applications not requiring clinical data and supplements with clinical data will cost $979,400. The establishment fee will be $526,500 and product fee will be $98,380, according to the notice.

The fee to reactivate a withdrawn biosimilar application will be $391,760, which is equivalent to 20% of the marketing application cost.

Reactivation fees would be charged if a sponsor voluntarily suspends product development to avoid paying the annual product development fee, but later wants to resume development.

Sponsors that do not pay annual BPD fees face a “financial hold” of their application, where FDA prohibits the sponsor from further product development Also see "Biosimilar User Fee Agreement Includes “Financial Hold” On Development Programs For Failure To Pay" - Pink Sheet, 6 December, 2011..

In addition to starting the user fee program, FDA is considering biosimilar naming conventions and additional guidances on issues such as interchangeability Also see "Biosimilars’ Next Big Hurdle For FDA Could Be Clinician Education" - Pink Sheet, 4 June, 2012..

The agency issued three biosimilar draft guidances earlier this year, though industry is still searching for more details Also see "Biosimilar Interchangeability: Stakeholders Want More FDA Guidance, Fewer Hurdles" - Pink Sheet, 30 April, 2012..

FDA Sets Biosimilar Application Fees, But Is Silent On Volume Projections

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