Amgen on Soliris: Low patient population but high biosimilar potential

The high cost of Alexion’s ultra-orphan disease MAb Soliris (eculizumab) drove Amgen’s decision to develop a biosimilar version, says SVP of Global Development Elliott Levy.

Soliris (eculizumab) is an approved treatment for orphan diseases paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (a-HUS) treatment.

The monoclonal antibody (MAb) was – until the arrivals of CAR-T and gene therapies Kymriah, Yescarta and Luxturna last year – the most expensive drug in the world, and netted Alexion $3.1 billion (€2.8 billion) in global sales last year.

Alexion’s Soliris (eculizumab) is the highest priced monoclonal antibody available in the US

As an orphan drug, the patient population is very small, but this high revenue potential is driving the development of Amgen’s eculizumab biosimilar ABP 959, Elliott Levy, Amgen’s senior vice president of Global Development said.

“The interest in a biosimilar in this area is intense,” he said. “Of all the [biosimilar] areas that we’re developing, the enthusiasm has been greatest in this area where the originator product is quite costly and we think it’s an area that’s well-suited to our strategic model.”

Amgen’s ABP 959 is in Phase III clinical trials. There are other biosimilar developers looking to bring their eculizumab products to market, including Samsung Bioepis.

“We have, I think, demonstrated over the past few years that we are as good as any company in the world at discovering biologic molecules that faithfully reproduce the structural and performance attributes of the originator compound, and then getting those drugs through the regulatory process in a hiccup-free fashion, and then launching them around the world,” Levy added.

Manufacturing infrastructure

Arvind Sood, Amgen’s head of Investor Relations, also spoke on the issue at the conference, telling stakeholders one of the capabilities needed to succeed in the biosimilar business is having a robust manufacturing set-up.

“We certainly have the manufacturing capabilities,” he said, adding “these products have to be commercialized by their own distinct nonproprietary name, so you need a commercial infrastructure.”

“In aggregate, we are pursuing biosimilars against 10 products and – in a branded form – these products are generating over $65 billion in revenue. So our biosimilar strategy is already beginning to come to fruition.”