Sandoz’ biosimilar to Enbrel was approved in 2016 by the FDA but has remained off the market due to the patent protection surrounding Amgen’s blockbuster rheumatoid arthritis treatment.
Sandoz, Novartis’ biosimilar-developing division, is planning to appeal a U.S. District Court ruling against Erelzi (etanercept-szzs), the company’s biosimilar to Amgen’s blockbuster rheumatoid arthritis drug, Enbrel (etanercept). The ruling prevents the company from launching its biosimilar at this time.
On Friday, the U.S. District Court of New Jersey ruled in favor of two Amgen patents that describe the making of Enbrel. Sandoz argued that the patents that cover Enbrel’s active ingredient should not be valid. Amgen sought to protect Enbrel’s revenue stream. Last year, Enbrel generated $4.8 billion for the Thousand Oaks, Calif.-based company. Enbrel’s patents do not expire until 2029 – a full 10 years from now. Sandoz announced late Friday that it plans to appeal the District Court’s ruling to the U.S. Court of Appeals. Both parties have agreed to an expedited appeal, Sandoz said in its announcement.
Friday’s ruling sent a wave of relief through Amgen investors. Shares of Amgen spiked 6% in late-afternoon trading to close at $196.25. Shares of Novartis, Sandoz’ parent company, fell less than 1% to close at $90.82. However, Novartis shares are up slightly in premarket trading this morning.
Carol Lynch, head of Sandoz North America, said the company “respectfully disagrees” with the District Court judge’s ruling, which prevents the launch of Erelzi in the United States.
“Valid intellectual property should be respected, however, we continue to consider the patents, in this case, to be invalid. Amgen asserted two patents that it obtained from Roche, in what we believe is an attempt to extend its US compound patent protection for etanercept to 2029. We will appeal this decision, and look forward to presenting our case to the Federal Circuit and bringing Erelzi to US patients as soon as possible,” Lynch said in a statement.
Erelzi was approved by the U.S. Food and Drug Administration in 2016 as a biosimilar for Enbrel, which was first approved in 1998. Despite the fact that Erelzi was approved three years ago, Sandoz has been unable to launch the drug due to the patents protecting the Amgen product. Enbrel was developed by Immunex, which was acquired by Amgen four years after the drug’s approval.
In arguing its case in the court of public opinion, Sandoz pointed to the financial benefits of biosimilar drugs. In particular, Sandoz pointed to the approval of its own Zarxio (filgrastim-sndz), a biosimilar to Amgen’s Neupogen. Since it was approved in 2015, Sandoz said Zarxio saved the U.S. healthcare system approximately $500 million.
Amgen Chief Executive Officer Robert A. Bradway said Friday that he was pleased with the decision “recognizing the validity of these patents.” He said protecting the intellectual property supporting Enbrel is “critical to incentivize innovation and the large investments in research and development that are required to bring new medicines to patients and fully develop their therapeutic potential for patients.”
Amgen isn’t the only company to use patent law to protect the revenue generated by drugs in its portfolio. Illinois-based AbbVie has successfully staved off biosimilar challenges to its blockbuster rheumatoid arthritis drug Humira until 2023. Biosimilar drugs for Humira only recently became available in Europe and are still unable to compete with Humira in the United States until 2023. In Europe, Humira is now being challenged by biosimilars developed by Amgen, Novartis, Samsung Bioepis and Mylan.
