- Biosimilar makers could be able to move copycat versions of pricey biologic drugs to market more quickly following a closely watched ruling from the Supreme Court Monday, which overturned an earlier decision by a federal appeals court.
- In a unanimous opinion written by Justice Clarence Thomas, the Supreme Court ruled that a biosimilar drug developer would not have to wait until receiving approval from the Food and Drug Administration to provide branded drugmakers a mandated 180-day notice of commercial marketing.
- Novartis' Sandoz division and Amgen, the two parties involved in the case, have been battling over conflicting interpretations of the Biologics Price Competition and Innovation Act (BPCIA), which established an expedited path for regulatory approval of biosimilars. Amgen had sued Sandoz in 2014, claiming the generics unit failed to follow the BPCIA when submitting its since-approved biozimilar Zarxio (filgrastim-sndz) to the FDA.
While biosimilars have an established presence in Europe, the cheaper versions are only just starting to edge into U.S. markets. The FDA has approved five biosimilars to date, but only two — Sandoz' Zarxio and Pfizer's Inflectra (infliximab-dyyb) — have actually been launched for commercial sale.
Patent litigation and a evolving legal framework have slowed the debut of others; one reason why the case between Sandoz and Amgen attracted so much attention.
While six months may appear to be a short amount of time, it can translate to hundreds of millions in sales for branded biologic drugs and help the original developer better prepare for cheaper competition. Sandoz, in defending the suit from Amgen and later appealing the federal appeals court's decision, argued Amgen's interpretation of the BPCIA would effectively extend its 12-year regulatory exclusivity.
Now, biosimilar makers will be able to submit a 180-day notice of commercial marketing before FDA approval, enabling a launch immediately following licensure — much like the current system for generic drugs under the Hatch-Waxman act. (Pending patent litigation could still trip up or delay market entry of biosimilars, though.)
"The Supreme Court seems to have largely sided with Sandoz — and other biosimilar applicants — in its first interpretation of the patent dispute resolution procedures of the Biologics Price Competition and Innovation Act," said Courtenay Brinckerhoff, an intellectual property partner in the biosimilars practice at Foley & Lardner LLP.
Brinckerhoff believes the ruling could encourage biosimilar applicants to engage with branded drugmakers in the so-called "patent dance" in order to ensure legal disputes are resolved before any FDA approval. The patent dance refers to a process where an applicant seeking FDA approval of a biosimilar has to provide its application and manufacturing information to the original drugmaker. The two parties then work to resolve potential issues of patent infringement based on those details.
As part of Monday's decision, the Supreme Court held that an injunction mandating biosimilar developers exchange information with branded drugmakers would not be available under federal law. The justices remanded the case to the U.S. Appeals Court for the Federal Circuit in order to reconsider whether branded drugmakers could obtain such an injunction under state law.
The decision, unsurprisingly, pleased Sandoz.
"The Justices’ unanimous ruling on the notice of commercial marketing will help expedite patient access to life-enhancing treatments," said Carol Lynch, global head of biopharmaceuticals at Novartis' Sandoz unit in a statement. "We also appreciate the clarity provided on the patent dance, which will help the biosimilars industry move forward."
While Amgen had its arguments rebuffed by the Supreme Court, it could also stand to gain under the new interpretation of the BPCIA.
Amgen fought Sandoz in court to defend its drug Neupogen (filgrastim) from biosimilar competition. At the same time, the biotech has also been developing its own portfolio of biosimilars, drugs which will likely benefit from Monday's ruling.
Indeed, Amgen had previously received FDA approval of its biosimilar Amjevita (adalimumab-atto), a version of AbbVie's top-selling Humira (adalimumab). The biotech has an array of other biosimilars in development, including copies of Roche's Herceptin (trastuzumab) and Avastin (bevacizumab) as well as J&J's Remicade (infliximab).