At J.P. Morgan, Amgen and Sanofi Balance Novel Drugs and Biosimilars, Alexion Hopes to "Convert" Patients

The second day of the 37th Annual J.P. Morgan Healthcare Conference saw presentations from drug makers Amgen and Sanofi—both of whom produce both innovator products facing biosimilar competition as well as biosimilars of competitors’ products—as well as from Alexion, which is defending its flagship product from advancing biosimilar challengers.

Amgen Says Biosimilars Will “Contribute Significantly” in 2019

Robert Bradway, chief executive officer of Amgen, called biosimilars an area poised to deliver long-term growth for the company, saying that “we expect our biosimilars business to begin to contribute significantly” to the company financially for the first time in 2019.

He highlighted the launch of the first 2 of Amgen’s biosimilars, Amgevita, an adalimumab biosimilar referencing Humira, and Kanjinti, a trastuzumab biosimilar referencing Herceptin. Amgevita launched in Europe in October 2018, while Kanjinti launched in multiple ex-US markets this year (though the product received a Complete Response Letter from the FDA in June 2018).

He also noted that the company expects to receive European regulatory clearance for its infliximab biosimilar, ABP 710, during this quarter, and that the company is moving forward with phase 3 trials of its rituximab and eculizumab biosimilars, as well as with process development of a cetuximab biosimilar and a further 3 undisclosed molecules.

In total, said Bradway, the market that Amgen is targeting with its biosimilar program is worth approximately $65 billion.

However, the company finds itself preparing for biosimilars to target some of its reference products. The brand-name etanercept, Enbrel, already faces ex-US biosimilar competition, and will face competition from Sandoz’s Erelzi in the United States after the conclusion of patent litigation. Bradway said that Amgen is focused on making strategic investments in studies of the branded drug, and in “attractive delivery devices that we think enhance the patient experience” with the product.

Similarly, with new competition from pegfilgrastim biosimilars, Amgen is investing in its on-body delivery device for the brand-name Neulasta—Onpro—which Bradway said has captured 60% of the pegfilgrastim market.

Finally, to guard against new biosimilar competition for its branded epoetin alfa, Epogen, Amgen is seeking to shift patients at small and midsized dialysis centers to Aranesp, darbepoetin alfa, which retains patent exclusivity in the United States until 2024.

Admelog Helps Sanofi Overcome Loss of Exclusivity on Other Products

Jean-Baptiste Chasseloup de Chatillon, executive vice president and CFO of Sanofi, said in his presentation that, while the company faced the impact of loss of patent exclusivity for some of its products in 2018, its new therapies more than compensated for the financial impact.

Loss of exclusivity for Sanofi’s insulin glargine, Lantus, meant competition from the Eli Lilly follow-on, Basaglar, in the United States elsewhere, as well as Mylan and Biocon’s Semglee in ex-US territories.

However, among the new products launched last year by Sanofi was Admelog, a follow-on insulin lispro referencing Humalog. This product, together with its numerous other 2018 launches, said de Chatillon, delivered a return to growth for Sanofi. “Our new product launches began to deliver revenues greater than the loss of exclusivity impact in the third quarter,” he said, noting that Sanofi’s third-quarter sales reached €319 million (approximately $362 million) versus an impact from loss of exclusivity of €231 million (approximately $265 million).

In 2019, however, Sanofi could face “a headwind in diabetes” due to increased contributions to the Medicare Part D coverage gap, as well as some loss of coverage in Medicare Part D for its products.

Alexion to “Convert” Soliris Base to Ultomiris as Biosimilars Draw Closer

Ludwig Hanston, chief executive officer of the rare disease drug maker Alexion Pharmaceuticals, kicked off his presentation by celebrating the early FDA approval of ravulizumab, Ultomiris, a C5 complement inhibitor that is a follow-up to the company’s flagship drug, eculizumab, sold as Soliris.

The newly approved drug is indicated to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), and has an advantage of less frequent dosing than eculizumab. The drug also has the benefit of new patent exclusivities that could help Alexion stave off competition from oncoming eculizumab biosimilars.

However, Alexion’s base of patients receiving eculizumab continues to grow. Hanston said that the company had its strongest launch for the drug to date in generalized myasthenia gravis (MG), with 788 patients receiving the drug in December of 2018 after a fourth-quarter 2017 launch.

"To put things into perspective," he said, "[in the] second quarter of 2017, which was 10 years after the launch of Soliris, we had about 2500 patients” receiving the drug for PNH. “One year into the launch, we have close to 800 [MG] patients—the way that we’re going, we believe that this is going to be a major focus for us...this has the potential to become our biggest franchise in the short term.” The focus on MG also signals a shift for Alexion from ultra-rare diseases to rare diseases that have larger addressable patient populations, he said.

Looking ahead, however, Hanston says the company is looking at “converting Soliris to Ultomiris” among patients with MG, and is about to undertake a phase 3 study of the drug in this indication with a view toward an expanded label.