Judge rejects Amgen’s attempt to block first US biosimilar launch

20-Mar-2015 - Last updated on 20-Mar-2015 at 15:09 GMT

A district court judge from California has denied an injunction by Amgen meant to stop the launch of the first biosimilar approved by the US FDA – Sandoz’s Zarxio (filgrastim-sndz).

“As the twelve-year exclusivity period for Neupogen long ago expired, there exists no substantive bar to market entry for Sandoz’s biosimilar filgrastim—and, consequently, no basis on which Amgen is entitled to injunctive relief or other remedies for disadvantages it may suffer due to market competition from Sandoz,” US Northern District of California Judge Richard Seeborg said in his order from Thursday.

Amgen originally filed suit when Sandoz failed to provide it with certain information from its biosimilar application, including on the manufacturing processes.

However, the judge ruled that in some instances, this information does not have to be provided.

“The BPCIA [Biologics Price Competition and Innovation Act] renders permissible a subsection (k) applicant’s decision not to provide its BLA [Biologics Licensing Application] and/or manufacturing information to the reference product sponsor,” Seeborg said. “Such a decision alone does not offer a basis for the sponsor to obtain injunctive relief, restitution, or damages against the applicant.”

The judge also dismissed claims of harm by Amgen that would come if Zarxio were to be launched.

“Not only are such harms at best highly speculative; they are based on the as-yet unproven premise that Sandoz has infringed a valid patent belonging to Amgen,” he added. In addition, Amgen’s claims that it should receive more market exclusivity were denied.

“Because the FDA cannot license a biosimilar until twelve years after approval of a reference product, Amgen’s reading would tack an unconditional extra six months of market exclusivity onto the twelve years reference product sponsors already enjoy,” the judge said.

Pricing Questions Remain

But questions remain around the pricing of the first biosimilar, details of which were not included in this latest order. Many experts anticipate the biosimilar will undercut the price of Neupogen. Amgen, however, raised a number of questions around the expected pricing in a February 5 motion filed in the US District Court of the Northern District of California.

“If Sandoz intends, as it has suggested, to price its product at the level of Neupogen’s Wholesale Acquisition Cost, or WAC price, and then offer doctors discounts or rebates from that price, Sandoz will harm the public interest and irreparably harm Amgen in the process,” Amgen claimed, noting that Medicare could inevitably end up paying more for the newly introduced product.

“Sandoz should not be heard to argue anything about the public interest. It has suggested publicly that it will price its biosimilar filgrastim product at or above Amgen’s Wholesale Acquisition Cost for Neupogen. Offering a biosimilar copy of an existing product at a higher cost to Medicare is not benefitting the public.”

As an illustrative hypothetical, Amgen assumed that Amgen’s WAC (wholesale acquisition cost) for a vial of Neupogen is $100 and its ASP (Average Selling Price) is $85. A doctor pays Amgen $85 for a vial, and the doctor is paid $90 by Medicare to reimburse the doctor (because $90 = 106% of $85), and thus profits $5. Because Sandoz’s product is new to the market, however, it will have no ASP for six to nine months. In the meantime, Medicare (and most private payers) will reimburse doctors at Sandoz’s listed WAC price plus 6% of Amgen’s ASP. If Sandoz prices at Amgen’s WAC price, the doctor will pay Sandoz $100 for a vial, and receive $105 dollars from Medicare (because $100 + (6% of $85) = $105). The doctor will thus make the same $5, but Medicare will have to pay $15 more for Sandoz’s product ($105) than for Neupogen ($90).