Biosimilar earnings were due in large part to the European launches of biosimilar trastuzumab (Kanjinti) and biosimilar adalimumab (Amgevita), which Amgen said are progressing in line with expectations and annualizing at more than $300 million.
Amgen said last week that its biosimilars business generated $82 million in sales in the second quarter of the year. That number represents total growth of 49% over the previous quarter.
Those earnings were due in large part to the European launches of biosimilar trastuzumab (Kanjinti) and biosimilar adalimumab (Amgevita), which Amgen said are progressing in line with expectations and annualizing at more than $300 million. Kanjinti recently also launched in the United States, along with biosimilar bevacizumab, Mvasi.
However, in addition to making strides with its own biosimilars, Amgen faces competition for market share from other drug makers’ biosimilars of its innovator products. Brand-name Neulasta, Amgen’s innovator pegfilgrastim product, exited the second quarter with 80% of the market share for long-acting pegfilgrastim, a scenario that it said reflects a competitive biosimilars market.
In the company's earnings call, Muro Gordon, Amgen’s head of commercial operations, said, “We are seeing an uptick of biosimilars in the 340B channel. We're also seeing a stronger performance of biosimilars in business that we have not contracted.” He later added that, since the market entry of the second biosimilar pegfilgrastim (Coherus BioScience’s Udenyca, following Mylan and Biocon’s earlier Fulphila), Amgen has seen more volume erosion and price erosion for its brand-name product.
Internationally, sales of Neulasta declined by 31% due to competition. However, Amgen’s sales of the Onpro presentation of the product, which delivers pegfilgrastim via an on-body injector, were stable quarter over quarter. In the future, said Gordon, “we may see some price pressure on Onpro.”
Looking to the next steps for its own biosimilars business, Amgen indicated that it expects phase 3 data from a study in patients with non-Hodgkin lymphoma for its biosimilar rituximab candidate, ABP 798, during the current quarter. The company, together with partner Allergan, previously announced positive topline results for the product in a combined phase 1 and phase 3 study of the proposed biosimilar in patients with rheumatoid arthritis.
It also expects the FDA to make its regulatory decision on ABP 710, a proposed biosimilar infliximab, in December of this year. The company recently informed the European Medicines Agency that it will not pursue approval in Europe, however, following a change in its strategy for the European market.
Finally, as he closed the earnings call, Amgen’s chairman and chief executive officer, Bob Bradway, hinted that the company had “the prospect of branded biosimilars” in the future. Branded biosimilars, a product strategy that is also apparently being explored by Eli Lilly and Company, could see brand-name drug makers selling their biologics under as structure similar to that used for authorized generics.