Biosimilars Gain Market Share and Advocates Get Aboard

At the end of the second quarter of 2020, various companies saw their biosimilars improve in market share, despite the economic challenges imposed by the coronavirus disease (COVID-19) pandemic. Recent public statements and reports have increasingly recognized biosimilars as a lower-cost solution to health system difficulties.

Much of the biosimilar advancement occurred in the oncology space, where biosimilars for infliximab and rituximab have overshadowed their reference products by capturing a superior amount of market share. These trends can be expected to continue.

In a recent report, Vizient, which specializes in finding low-cost health care alternatives for its membership, told health care systems to lean more heavily on biosimilars to achieve greater savings. “Members must continue to work with their colleagues that manage payer relationships to promote biosimilars,” the company said.

Vizient noted a recent JAMA analysis that found relatively few commercial US health plans designated biosimilars as preferred drugs on formulary. Further, Vizient noted a huge tab among its membership for drugs for which biosimilars are approved in the United States but not yet marketed. Those include adalimumab and etanercept, which account for 19.15% and 16.50% of the top 10 disease-modifying agents used by its membership, respectively.

In a virtual conference this past week sponsored by the Pacific Business Group on Health (PBGH) and the Integrated Benefits Institute (IBI), employers were urged to use their influence on payers to get biosimilars into play. “Cost savings is being left on the table,” said Juliana Reed, MS, a vice president and Global Corporate Affairs lead for Pfizer and current president of the Biosimilars Forum, a trade group representing pharmaceutical manufacturers.

She put a figure of $20.4 billion on that “lost savings,” which she said was forfeited to originator drugs from 2018 to 2020.

Celltrion’s Hold on Oncology Markets

Remsima, an infliximab biosimilar developed by Celltrion Healthcare and Pfizer, has amassed 57% of the European market share compared with reference Remicade (28%), according to Celltrion’s second quarter earnings release. It took Remsima 4 years on the market to grasp a 50% market share.

In the United States, where the same drug is marketed as Inflectra, its market share has been on a more gradual rise for 40 months and now stands at 10.5%.

A product to watch is Celltrion’s subcutaneous version of Remsima (Remsima SC), which in June received a Committee for Medicinal Products for Human Use recommendation in Europe for 5 new indications to supplement its existing indication for rheumatoid arthritis. The drug is undergoing a phase 3 clinical trial in the United States.

Additionally, Celltrion said that in Europe its rituximab biosimilar Truxima has surpassed the market share of reference Rituxan (40% vs 34%) in the almost 3 years since launching.

Overall, trastuzumab biosimilars, including Celltrion’s Herzuma, have amassed 45% of the European market compared with reference Herceptin (55%), according to Celltrion.

Amgen Gears Up for Competition

According to Amgen’s second-quarter earnings report, the company’s trastuzumab biosimilar (Kanjinti), which launched in the United States in 2019, ended the quarter with a 32% market share in the United States even as the trastuzumab market has seen increased competition; in December 2019 the first of 4 other trastuzumab products launched, starting with the entry of Mylan and Biocon’s Ogivri.

Amgen said its bevacizumab biosimilar, Mvasi, had an market share of 39% in the United States at the end of the quarter. Amgen expects increased competition in the United States given the December 2019 launch of Pfizer’s bevacizumab biosimilar (Zirabev).

Neulasta vs Udenyca

Biosimilars have charged into the pegfilgrastim market, too. Amgen saw a 28% decrease in sales for reference product Neulasta this past quarter, as a result of biosimilar competition.

However, Amgen still reigns champion in the pegfilgrastim market after developing the wearable injection product Neulasta Onpro, which among all pegfilgrastim products, increased in market share to 58% this past quarter, according to the company.

The company saw a 35% drop in sales for its filgrastim reference product, Neupogen, during the same period, and a 28% revenue decline for its epoetin alfa reference product, Epogen. These products also face biosimilar competition.

Alexion, faced with competition from Amgen’s eculizumab biosimilar in 2025, has rapidly been converting patients from eculizumab reference (Soliris) to a follow-on product (ravulizumab, Ultomiris). These products are for the treatment of paroxysmal nocturnal hemoglobinuria. Alexion said 70% of its patients for Soliris have been converted to Ultomiris, which means Ultomiris could become another Onpro-like success story.

During a quarterly earnings call, Dennis Lanfear, president and CEO of Coherus Biosciences’, said that its pegfilgrastim biosimilar, Udenyca, saw a dip in market share, due to the COVID-19 pandemic, after being on the rise during the first quarter. Udenyca ended the second quarter with a market share of about 19% compared with 22% from the first quarter.

“We feel that we can continue to come out of [the 2020 second quarter] and perform as we have. I think we're doing very well in the face of COVID and existing competition and continue some share growth. But how that translates to revenues for 2020 is another issue. I would like to be able to give you more color and a bigger commitment with respect to share growth across 2020. But given COVID, that's a little tough to do,” said Lanfear.

Interchangeability

Meanwhile, much has been said about the lack, so far, of interchangeable biosimilars. Mainly an issue of nomenclature, interchangeability is an FDA designation that allows biosimilars to be substituted for reference drugs at the pharmacy counter, without the physician’s consent.

In their zeal for biosimilars, some are finding ways around this regulatory hurdle that prevents them from implementing a lower-cost biosimilar solution.

“Where the biosimilar exists with the specific value-based contracts that we're trying to achieve, we give our pharmacists the green light to perform that interchange behind the scenes,” Lucy Langer, MD, chair of the National Policy Executive Committee for The US Oncology Network, told employer groups this past week at the PBGH and IBI symposium. Langer is practice president of Compass Oncology West in northern Oregon.