Following the FDA’s March 6, 2015, approval of the first biosimilar in the United States — Zarxio (filgrastim-sndz) from Novartis Pharmaceuticals Corp.’s Sandoz unit — these agents have continued to gain market share, even though not all that have been approved have launched. And while the European Union approved its first biosimilar, Sandoz’s Omnitrope (somatropin), almost a decade earlier on April 12, 2006, the U.S. outpaced the EU in biosimilar approvals in the eight-year post-launch period 40 to 15. Last year continued the trend, with the FDA approving seven new biosimilars. AIS Health, a division of MMIT, asked some industry experts about the agents’ impact over the past year.
AIS Health: Could you please comment on biosimilars’ impact in 2022, particularly within the oncology space?
Chanttel Melquist, Pharm.D., clinical program pharmacist at Prime Therapeutics LLC: Seven biosimilars have been approved in 2022. Five of the biosimilars launched in the United States are in one drug class, called granulocyte-colony stimulating factor, or G-CSF. This drug class treats neutropenia, a condition that’s often a side effect from cancer. About 11,000 patients every year take a G-CSF drug, generally for about six months. But because it’s for patients with cancer, there’s a continuous entry of new people who need a G-CSF drug, every month, every year.
G-CSF biosimilars are priced 10% to 30% lower than their reference biologics. The FDA review affirms there’s no clinically significant difference between a biosimilar and its reference biologic. A biosimilar offers savings while delivering the same health outcomes. One would then expect that health plans and payers would convert quickly to the biosimilars, but unfortunately, the conversion to a biosimilar is still a tough sell.
Arash Sadeghi, Pharm.D., clinical pharmacist at Optum Rx, Inc.: Today, approximately one in four new drugs are biologic. In fact, of the 50 new drugs approved by the FDA in 2021, 14 were biologic.
In 2022, the second interchangeable biosimilar [of Sanofi’s] Lantus was approved, insulin glargine-aglr (Rezvoglar [from Eli Lilly and Co.]). Semglee [(insulin glargine-yfgn) from Viatris Inc.] was the first interchangeable biosimilar Lantus launched in 2021. An interchangeable biosimilar product may be substituted for the reference product by the pharmacist without the intervention of the prescriber (like generic drugs being substituted for brand name drugs), subject to state pharmacy laws.
The biosimilars available today primarily focus within the oncology space. There are five biosimilars for trastuzumab (Herceptin [from Genentech USA, Inc., a member of the Roche Group]), four for bevacizumab (Avastin [also from Genentech]) and some for oncology supportive care, such as filgrastim (Neupogen) and pegfilgrastim (Neulasta), [both from Amgen Inc.].
Biosimilars provide one of the biggest opportunities to lower costs, with potential savings exceeding $100 billion over the next five years, and increase accessibility for consumers.
Biosimilars have been in the works for several years, but due to the approvals process taking five to 10 years, we are now starting to see their impact. One example is Humira biosimilars and potentially Stelara [(ustekinumab) from Johnson & Johnson subsidiary Janssen Biotech, Inc.] biosimilars coming to market in 2023, which is positioned to be a monumental year.
Andy Szczotka, Pharm.D., chief pharmacy officer at AscellaHealth: To date, the FDA has approved 40 biosimilars, with seven of those coming in 2022 (Alymsys [(bevacizumab-maly) from Amneal Pharmaceuticals LLC], Cimerli [(ranibizumab-eqrn) from Coherus BioSciences, Inc.], Fylnetra [(pegfilgrastim-pbbk) from Amneal], Releuko [(filgrastim-ayow) from Amneal], Stimufend [(pegfilgrastim-fpgk) from Fresenius Kabi USA, LLC,] Vegzelma [(bevacizumab-adcd) from Celltrion USA and Fresenius Kabi’s Idacio [(adalimumab-aacf)]. The newly approved biosimilars in 2022 did not have a significant market impact on spend or utilization; the biosimilar impact is being seen with the continued growth and acceptance of the approvals from prior years. The biosimilars being used extensively include infliximab (Remicade [from Janssen]), filgrastim (Neupogen), insulin glargine (Lantus), pegfilgrastim (Neulasta) and the oncology biosimilars.
The biggest impact oncology biosimilar products are bevacizumab (Avastin), trastuzumab (Herceptin) and rituximab (Rituxan [from Genentech and Biogen]). According to Cardinal Health, each of these biosimilars has exceeded 60% market share in 2021 and will likely have increased in 2022. Oncologists have embraced using biosimilars for their patients. The American Society of Clinical Oncology (ASCO) in 2020 published an update to its guideline on treating early-stage breast cancer in which it endorsed the use of biosimilar trastuzumab. An ASCO expert panel also supported the inclusion of FDA-approved biosimilars in clinical practice guidelines. The utilization of the biosimilars in each of these products has continued to increase with both preferential payer positioning and adoption by physicians and patients, which provides cost-effective options for both patients and payers.
Payers are actively planning for biosimilars in 2023 with the anticipated launch of the adalimumab (Humira) biosimilars. Additional high impact biosimilars that may be launched in 2023 include tocilizumab (Actemra [from Genentech]) and ustekinumab (Stelara). Each of these will provide potential cost savings opportunities for payers and patients.
Mesfin Tegenu, CEO and chairman of RxParadigm, Inc.: Biosimilars saw an upward trend in 2022 and will continue to do so because of additional drugs losing patent protection. Most of the approved biosimilars available on the market are oncology biosimilars, and there are several oncology biosimilars in the pipeline. The rising cost and prevalence of chronic diseases will fuel the biosimilar market and enhance accessibility and affordability of biologics for patients.
Drew Walk, CEO of Soleo Health: While Soleo Health has limited exposure to oncology biosimilars, we have seen accelerated adoption of biosimilars in nononcology therapeutic areas, specifically with Remicade (infliximab), for the treatment of chronic inflammatory diseases.
We are seeing more payer-mandated biosimilar formularies surfacing in the marketplace, requiring prescribers to utilize a biosimilar for potential payer cost savings.
Winston Wong, Pharm.D., president of W-Squared Group: Biosimilar utilization is now being included in clinical pathway decision trees. In the 2022 JCP [i.e., Journal of Clinical Pathways] Benchmark Survey on Clinical Pathways, 60% of the respondents indicated that biosimilars were actively promoted as part of their pathway treatment options. In addition, in the September issue of JCP, Hamilton et al. submitted a piece describing a program where three biosimilar products were preferenced, requiring the use of a biosimilar product prior to the use of the reference product within their clinical pathway. The result was an increase in biosimilar utilization, leading to significant reduction in medical claims costs on a PMPM [i.e., per-member per-month] basis compared to a population with no active management.
Contact Melquist through Jenine Anderson at firstname.lastname@example.org, Sadeghi via Jennifer Statham at email@example.com, Szczotka through Caroline Chambers at firstname.lastname@example.org, Tegenu at Mesfin.Tegenu@rxparadigm.com, Walk via Susan Turkell at email@example.com and Wong at firstname.lastname@example.org.
By Angela Maas