As Biosimilars Emerge in Oncology and Rare Disease, Innovator Companies Look to New Drugs to Maintain Sales

As innovator biologics that have achieved blockbuster sales status reach or near the end of their exclusivities, biosimilar competition is close behind. This week, stakeholders got a closer look at how innovator drug companies are positioning themselves to maintain their sales in the face of such competition.

For Roche, New Products Help Compensate for Biosimilar Erosion

In its third quarter results, Roche reported that its pharmaceuticals division saw its sales increase by 12%, mainly driven by demand for recently launched drugs, including its multiple sclerosis drug ocrelizumab (Ocrevus), its hemophilia A drug emicizumab (Hemlibra), and oncology drugs atezolizumab (Tecentriq) and pertuzumab (Perjeta).

In Europe, Roche faced competition from biosimilar trastuzumab and biosimilar rituximab, and saw its sales drop for the products by 44% and 33%, respectively. However, that decline was “almost offset,” said the company, by growth from its other products. Roche also faced biosimilar competition for rituximab in Japan, which reduced its sales of the brand-name product by 46%, but overall, its overall Japanese sales were up by 11% on the strength of newly launched products.

Sales of the brand-name trastuzumab were also down by 4% in the United States, a fact that Roche attributed to greater use of trastuzumab emtansine (Kadcyla) in the adjuvant setting rather than to the launch of the first US biosimilar. Increased sales in China made up part of the difference in sales, Roche said.

Notably, brand-name bevacizumab, Avastin, did not appear to take a hit from newly a newly launched biosimilar, even seeing its sales increase 8% overall and 7% in the United States.

Alexion Diversifies Its Pipeline With a New Acquisition

Separately, rare disease drug maker Alexion, the company behind the C5 complement inhibitor eculizumab (Soliris) and its less frequently dosed successor, ravulizumab (Ultomiris), announced this week that it has entered into an agreement to acquire the clinical-stage biopharmaceutical company Achillion.

Achillion is focused on developing small-molecule inhibitors of Factor D to treat paroxysmal nocturnal hemoglobinuria (also an approved indication for eculizumab and ravulizumab) as well as the ultra-rare kidney disease C3 glomerulopathy, through a different part of the complement system. The drug maker has 2 clinical-stage products in development.

Ludwig Hantson, PhD, chief executive officer of Alexion, said in a statement that “Alexion has demonstrated the transformative impact that inhibiting C5 can have on multiple rare and devastating diseases. However, we believe this is just the beginning of what’s possible with complement inhibition.” He added that “Targeting a different part of the complement…addresses uncontrolled complement activation further upstream in the complement cascade, and importantly, leaves the rest of the complement system intact, which is critical in maintaining the body’s ability to fight infection. We believe this approach has the opportunity to help patients with diseases not currently addressed through C5 inhibition.”

In addition to the potential benefit to patients who are not currently served by eculizumab, another possible boon of the $930 million transaction is the fact that the acquisition helps to diversify Alexion’s pipeline of drugs and reduce its dependence on eculizumab for its sales in the face of oncoming biosimilar competition. Currently, both Amgen and Samsung Bioepis are in phase 3 development with biosimilar candidates, and the US Patent Trial and Appeal Board has instituted inter partes review proceedings on key patents covering the brand-name Soliris.