Notification of intent to market a biosimilar can be made prior to FDA approval.

An approval pathway for biosimilars in the US has only recently been employed, with less than a handful of drugs having received the go-ahead from FDA to date. Not surprisingly, there are still many issues to be worked out.

The US Supreme Court has had its say on the question of when the 180-day exclusivity period the Biologics Price Competition and Innovation Act of 2009 (BPCIA) can begin.

The case heard by the court was between Sandoz, the generic drug business of Novartis, and Amgen. Sandoz received FDA approval in March 2015 for its product Zarxio (filgrastim-sndz), which is a biosimilar of Amgen’s Neupogen (filgrastim). Both are for the treatment of patients with low white blood cell counts (neutropenia).

The BPCIA states that a biosimilar developer must notify the manufacturer of the branded biologic for which they will be marketing a biosimilar product. In this instance, Sandoz notified Amgen in July 2014, prior to receiving FDA approval for Zarxio. Amgen took Sandoz to court, stating that the notification should not have been made until after Sandoz received FDA approval. The timing of this notification is important because it affects both the 180-day exclusivity period for the originator product and the timing of commercial launch of the biosimilar

Earlier, a federal appeals court had ruled in Amgen’s favor, determining that the 180-day notification required under the BPCIA must come after FDA approval of the biosimilar. It had issued a federal injunction prohibiting Sandoz from marketing Zarxio until 180 days after it received FDA approval.

The US Supreme Court reversed this decision, indicating that Sandoz was in compliance with the requirement of the BPCIA and that the injunction should not have been issued. This decision is an important one. In essence, it means that biosimilar manufacturers will be able to launch their products as soon as the data exclusivity on the branded products they are competing with expires.

Another aspect of the case dealt with patent infringement issues. The biosimilar company is required to provide its marketing application and manufacturing information to the branded manufacturer, and if it does not, the latter has a “remedy” according to the BPCIA. In addition, the statute gives the biosimilar control over the first phases of patent litigation. Sandoz did not provide the application of information to Amgen; Amgen sued for an injunction requiring Sandoz to provide the information. Amgen also requested a determination by the court as to whether the BPCIA actually requires a biosimilar company to provide a copy of its application and manufacturing information.

The court treated Amgen’s requests as one question, assuming that biosimilar companies are indeed required to provide the information. It also said that because Sandoz did not provide the required information to Amgen, Amgen gained control over the patent litigation that would have belonged to Sandoz. This control was determined to be Amgen’s remedy.

There is disagreement within the industry over the impact of these decisions. Some believe that they will enable biosimilar manufacturers to hide information from innovator firms. Others believe they will lead to more rapid market entry for cheaper, advanced medications. Still, others fear it may lead to reduced innovation in the biologic drug sector. Only time will tell how biosimilar developers will choose to respond.

The US Supreme Court will also be hearing at least one other case related to the BPCIA on “the constitutionality of the primary alternative method available for biosimilar companies to challenge the validity of innovator patents prior to market entry.” As a result, uncertainty remains.