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Stakeholder Views on SCOTUS Purge of 6-Month Marketing Pause for Biosimilars


Pharmaceutical manufacturers, pharmacy benefit managers, and various trade groups respond to the recent Supreme Court decision on the 6-month marketing rule post FDA approval for biosimilars.

In a much-anticipated decision, the US Supreme Court ruled unanimously in the Sandoz v Amgen case that biosimilar makers do not have to wait an additional 180 days after FDA approval of their biosimilar product before they launch it. The ruling gives biosimilar makers the flexibility to provide notice of commercial marketing to the reference drug developer either before or after the FDA’s approval of their biosimilar product.

Sandoz developed a biosimilar for Amgen’s filgrastim (Neupogen), marketed as filgrastrim-sndz (Zarxio), which was the first biosimilar approved in the United States in 2015.

The court stated that there is no existing rule in the 2010 Biologics Price Competition and Innovation Act (BPCIA) that would force biosimilar makers to comply with the so-called “patent dance”—an information-exchange process in which a biosimilar maker provides manufacturing/patent information along with the Biologics License Application (BLA) to the reference drug maker—but said the issue should be decided by states.

The court’s ruling, written by Justice Clarence Thomas, was a response to one of the major questions the Justices considered at the April 2017 hearing on the case, during which Amgen sought to convince the court that Sandoz and other biosimilar makers would have to wait 6 additional months after FDA approval to market biosimilars. Sandoz argued that such a decision would effectively create an additional 6 months of market exclusivity.

Some analysts view the court’s decision as very narrow and they do not trust it to resolve all the issues in the case. In their opinion, this might set the stage for the FDA to be more involved in the patent dance and in further interpretation of the BPCIA. In a concurring opinion, Justice Steven Breyer wrote that Congress delegated to the FDA authority to interpret the terms of the BPCIA, and if the agency decides a different interpretation would better serve the objectives of the BPCIA, it may well have the authority to modify the court’s interpretation.

Carol Lynch, global head of biopharmaceuticals at Sandoz, said the Justices’ unanimous ruling on the notice of commercial marketing will help expedite patient access to life-enhancing treatments, and that the clarity provided on the patent dance will help the biosimilars industry move forward. Amgen’s spokesperson said the company was disappointed in the decision, and would continue to seek to enforce the company’s intellectual property against those parties that infringe upon their rights.

The SCOTUS decision was hailed by other biosimilar makers, which expect the decision to speed marketing of their biosimilars. Biocon’s corporate medical director Kiran Mazumdar-Shaw said, “We are pleased with the US Supreme Court decision as it clarifies that the BPCIA was intended to facilitate the entry of biosimilar drugs into the market and not grant an additional 6 months of exclusivity to innovators.” Biocon has 2 potential biosimilars currently under FDA review (pegfilgrastim and trastuzumab) and is in the process of filing a BLA for insulin glargine. “By reducing the uncertainty around the introduction of biosimilars in the US, this development augurs well for the continued expansion of the US biosimilars market,” she said.

The Biotechnology Innovation Organization (BIO), a biotechnology trade association that represents innovator biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and more than 30 other nations issued a statement expressing disappointment with the SCOTUS decision. BIO said the decision effectively gutted the BPCIA, a statute that had been carefully designed to facilitate timely resolution of patent disputes. “It will do nothing to expedite the delivery of biosimilars to market,” the group said. “To the contrary, it is likely to delay patient access to biosimilars.”

Pharmacy benefit managers (PBMs), including Express Scripts Holding Co, supported the SCOTUS decision. PBM industry group, the Pharmaceutical Care Management Association, stated that the ruling will help create more competition among costly biologic medications, “which is the key to reducing overall prescription drug costs for consumers, employers, government programs, and others.”

Several patient and consumer groups also applauded the decision. The Association for Accessible Medicines said the ruling was a huge victory for American patients and consumers, and that it would help speed patient access to biosimilars of expensive name-brand medications that treat cancer, rheumatoid arthritis, psoriasis, multiple sclerosis, and other life-threatening conditions. The AARP said the decision would speed up the time it took biosimilars to enter the market, to the benefit of consumers.

Payers, as represented by America’s Health Insurance Plans (AHIP), supported Sandoz’s position in the SCOTUS case, and said the SCOTUS ruling removed a key impediment to consumer access to lower-cost biosimilars and will allow for access to these drugs as soon as they have been approved by the FDA. Pharmacy groups, such as the National Association of Chain Drug Stores and the Healthcare Supply Chain Association also supported the SCOTUS decision, saying that delaying new biosimilars by imposing an addition 6-month delay in marketing was contrary to congressional intent to promote access to biosimilars when it enacted the BPCIA.

Even though the SCOTUS decision was a victory for Sandoz and other biosimilar makers, in the end Amgen could also eventually benefit from the decision because the company is developing biosimilars that will likely benefit by not having the additional 180-day waiting period for marketing.

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