Regulators on both sides of the Atlantic have agreed to review Novartis’ approval bid for a biosimilar to Biogen’s Tysabri. The potential green light could spell trouble for the multiple sclerosis blockbuster, which has become Biogen’s best-selling drug in the wake of generic competition to its MS pill Tecfidera.
Novartis’ generics unit Sandoz said Monday that the U.S. FDA had accepted the application for its Polpharma Biologics-partnered natalizumab copycat. Meanwhile, the European Medicines Agency accepted the biosim filing on July 15, the Novartis unit added.
Stateside, Novartis’ biosimilar application includes “all indications covered by the reference medicine Tysabri” for relapsing forms of MS, which include clinically isolated syndrome, relapsing-remitting MS (RRMS) and active secondary progressive disease in adults. Novartis also expects the med to snag a U.S. nod in Crohn’s disease.
Across the pond, the med is up to snare Tysabri’s European indication for treatment as a single disease-modifying therapy for adults with highly active RRMS, Sandoz explained.
As the first and only Tysabri biosim submitted for approval in Europe and the U.S., Novartis’ natalizumab copycat has the potential to “increase access while also delivering savings for healthcare systems,” Florian Bieber, global head of biopharmaceuticals development at Sandoz, said in a release.
He noted that while disease-modifying therapies have become a “cornerstone” in MS treatment, “access to affordable, high-quality treatment options is still a challenge.”
Novartis forged its natalizumab pact with Polpharma back in 2019. Polpharma oversees development, manufacturing and supply of the drug, while Sandoz is on deck to commercialize and distribute the biosim-to-be in “all markets.”
Sandoz boasts a stable of eight marketed biosims, with another 15 in various stages of its pipeline, the Novartis unit pointed out.
For the first half of 2022, meanwhile, Biogen’s Tysabri reaped a little more than $1 billion, according to the company’s earnings reports for the year’s first and second quarters. Over that same stretch, Tecfidera nabbed revenues of around $808 million, while MS successor Vumerity pulled down $265 million.
The last of Biogen’s Tysabri patents—which cover methods of treatment—are set to lapse in 2027, Biopharma Dive reports. Biogen’s chief financial officer Michael McDonnell recently told investors that the Big Biotech would try to delay biosimilar launches in court, though he acknowledged that “a biosimilar could launch upon approval in the U.S.,” as quoted by the news service.
Meanwhile, another patent in the U.S., plus a similar one in Europe, are set to expire on Feb. 25, 2023.
Compared to Novartis’ intravenous biosim application, Biogen in Europe has won approval for subcutaneous Tysabri, which could help the company mount a defense against the Novartis copycat-in-waiting, thanks to a potential convenience edge, Biopharma Dive added.
The potential Sandoz-Biogen showdown comes at a time when both company’s futures are in flux. Biogen, for its part, is still trying to recover from the ill-fated launch of its controversial Alzheimer’s disease drug Aduhelm. The company recently charted an Aduhelm inventory write-off, while reports surfaced earlier this month that the company’s $1 billion cost-cutting scheme had started to take a toll on employees in Massachusetts.
Meanwhile, Novartis has been mulling the fate of Sandoz ever since the advent of a strategic review last fall. Both a sale and a spinoff are on the table, though the recent market has made a spinoff somewhat more likely, Bloomberg reported earlier this month, citing people close to the matter. Novartis has said it plans to offer an update on its Sandoz review by year-end.