Federal appeals court reaffirms biosimilar launch rules
- A federal appeals court reaffirmed on Tuesday that biosimilar drugmakers are required to notify brand-name companies of their intent to sell a copy biologic six months before marketing the drug.
- Canadian drugmaker Apotex, which has applied for U.S. approval for a biosimilar version of Amgen's Neulasta, tried to argue it did not need to provide Amgen with notice of commercial marketing as it had already provided Amgen with manufacturing and patent information.
- The same court previously ruled in a related case pitting Amgen against Novartis' Sandoz unit, saying biosimilar drugmakers must wait until after receiving approval from the Food and Drug Administration before submitting their marketing notice.
Under the Biologics Price Competition and Innovation Act (BPCIA), a biosimilar manufacturer must provide brand-name drugmakers with 180-day notice before selling a copy biologic. Biosimilar makers such as Apotex and Sandoz want to be able to submit this notice 180 days before the FDA decides on approval, thereby enabling them to begin selling immediately after receiving a license.
While the issue at stake may appear a minor technicality, the rulings could set a broader precedent for the growing biosimilar market in the U.S.
In the earlier Amgen v. Sandoz case, the U.S. Court of Appeals for the Federal Circuit sided with Amgen and ruled Sandoz (and other biosimilar companies) must wait until after FDA approval, essentially granting brand-name drugmakers a de-facto six-month extension of market exclusivity.
Biologic drugmakers already have 12 years of market exclusivity and an extra six months would give them more time to prepare legal challenges to a new entrant, not to mention adding another half-years' worth of protected sales.
Sandoz appealed the decision and the Supreme Court is now considering whether to hear that case
With Tuesday's ruling in Amgen v. Apotex, the appeals court affirmed its previous ruling and further stipulated that providing notice commercial marketing is mandatory regardless of whether a biosimilar company has submitted manufacturing and patent information in the so-called "patent dance" under the BPCIA.
Apotex unsuccessfully argued it did not need to submit the 180-day notice because it had already informed Amgen by exchanging patent information.
Tentative biosimilar approvals?
Stacie Ropka, an intellectual property attorney from the law firm Axinn Veltrop & Harkrider, thinks these two rulings could have important implications for how the FDA approves biosimilar drugs.
"In the original Amgen v Sandoz, it sounded like [the appeals court was] suggesting the FDA could grant a license that was not effective. That would amount to something akin to a temporary or a tentative approval like they do under Hatch Waxman. [The court] stated this again in this ruling," Ropka said.
Essentially, as the market grows, more and more biosimilar makers will be applying to make copies of biologics still well within their 12 years of market exclusivity. Right now, most of the drugs targeted by biosimilar companies are older biologics nearing the end of their patent exclusivity.
According to Ropka, the two rulings imply biosimilar drugmakers could apply and win FDA approval for a copy of a biologic still under patent protection, submit their 180-day notice of marketing and be ready to sell their drug once the 12-year exclusivity period expires. The FDA grants such "tentative" approvals for generic copies of pharmaceuticals but there is no such language explicitly granting the agency that power for biosimilars under the BPCIA.
As the legal framework for biosimilars is still developing, these cases assume greater importance because of the precedent they set for future biosimilar drugs. Although the FDA has only approved two biosimilars to date, there are a number of companies with applications pending and dozens of others in clinical development.
Tuesday's ruling may also impact Amgen v. Sandoz. Ropka said the Supreme Court may elect not to hear the case after the appeals court's decision, although she noted it is difficult to know for certain.
The Supreme Court has invited the U.S. Solicitor General to file a brief on the Obama Administration's stance on the issue, although it is likely that the high court won't decide until later this year.
- Stat Court ruling on biosimilar launches could increase health care costs
- Regulatory Focus Biosimilar ‘Patent Dance’: Federal Circuit Rules 180-Day Notice is Mandatory
- U.S. Court of Appeals for the Federal Circuit Amgen Inc. vs. Apotex Inc.
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