The U.S. Supreme Court ruled that biosimilars don't have to wait another six months to go on the market

Source: on June 12, 2017, the U.S Supreme Court unanimously passed a highly anticipated ruling by 9-0 vote, and biological similar drug companies do not have to wait another six months before the commercial listing of biological similar drugs after the approval of FDA The move is expected to save a lot of money for the U.S health care system The key question is whether companies of similar biological drugs must provide 180 days' marketing notice to brand drug rivals after the products are approved by FDA "2009 The bpcia's notification clause for the commercial listing of biologicals is that "the applicant shall provide the reference product holder with not less than 180 days' notice prior to the first commercial listing of the licensed biologicals in accordance with 351 (k)", the purpose of which is to give the brand drug company time to decide what kind of patent challenge (if any) These six months are important Brand pharmaceutical companies have been franchising their biological products for 12 years, and an additional 180 day notice will give these companies more time to prepare for patent challenges, thus delaying the launch of biological similar drugs For a brief introduction to the background of the lawsuit, please refer to [the dispute between the Supreme Court's acceptance of the notice of listing of biological similar drugs and the dance of patents - January 22, 2017], for more information about the notice of listing of biological similar drugs and the dance of patents, please click the "read the original" link at the end of the article to log in to read The Supreme Court overturned the lower court's ruling, agreeing with Sandoz's appeal that biosimilars do not have to wait until FDA approval to provide 180 days of commercial listing notice to brand drug counterparties Justice Clarence Thomas wrote in the court opinion: "the applicant can provide the commercial listing notice before obtaining the permission Amgen's arguments against it are unconvincing, and its various policy arguments cannot overwhelm the concise language of the law The use of the term "licensed" in the law merely reflects the fact that the product must be "licensed" "on the date of the initial commercial launch." As a result, applicants can provide notifications before or after FDA approval The original text of PHS act § 351 (L) (8) (a)) is as follows: the subsection (k) applies shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensee subsection (k) Is the dance of patent compulsory? Another key issue in the dispute between the two companies is whether Sandoz needs to provide Amgen with a full copy of its application for a bioequivalent drug The Supreme Court justice directed the federal court of appeal to review whether biosimilars must provide branded drug companies with copies of listing applications and related manufacturing information within 20 days of FDA acceptance of their applications This will trigger a so-called "patent dance" in which companies exchange information In 2014, Sandoz filed an application for a bioequivalent drug with the FDA, but Amgen accused Sandoz of failing to provide it with the information required by law Amgen maintains its view that Sandoz should provide Amgen with information about the listing application and manufacturing plan within 20 days after the FDA accepts the application for biological similar drugs This gives branded drug companies the opportunity to review applications and determine which patents may be infringed and file lawsuits In response, sandzoz insisted that his interpretation of the law did not require him to provide Amgen with such information In 2014, a judge of the federal court ruled in agreement with Sandoz's view, and the federal court of appeal upheld the ruling that this part of the law is optional [the Federal Circuit Judge's opinion on the "patent dance" clause is inconsistent, and the lawsuit may continue on July 26, 2015] if Amgen wins this point, all bio similar drug companies will have to wait 20% after their application is accepted by FDA Disclose its application within days, and if the court determines that this provision is mandatory, all bio similar drug companies will be forced to participate in a time-consuming work William Jay, a partner at Goodwin Procter, explained that the Supreme Court now wants the federal court of appeal to decide whether an injunction can be issued under federal or state law Sanya sukduang, partner of Finnegan law firm, said: "people want the Supreme Court to be able to determine whether disclosure at the beginning of the process is necessary, but the court did not."