Biosimilars

The HHS Office of Inspector General will evaluate the extent and quality of Medicare Part D plan coverage for biosimilars to AbbVie Inc.’s Humira (adalimumab) and expects to issue a report on the study in 2025, according to a recent update to the OIG’s work plan.

The study could provide fodder for reforms to pharmacy benefit manager rebating practices and for changes in Part D coverage policy that could help boost the uptake of biosimilars. Stakeholders and policy makers have viewed adalimumab biosimilars as a test case for the viability of the biosimilar model.

The ulcerative colitis (UC) space has seen multiple new approvals recently that could focus payer management even more on the condition. Payers already take an aggressive approach toward managing branded agents within the class, according to a Zitter Insights survey.

While no cure exists for the inflammatory bowel disease, the FDA has approved numerous agents to treat signs and symptoms of the condition. In addition to the nine biosimilars of AbbVie Inc.’s Humira (adalimumab) that have launched in the U.S. in 2023, a handful of other therapies have been approved by the agency since late September. All of the agents offer maintenance dosing either through an oral or subcutaneous route of administration.

Since the FDA approved the first biosimilar — Zarxio (filgrastim-sndz) from Sandoz, then a division of Novartis Pharmaceuticals Corp. — on March 6, 2015, the agency has approved more than 40 additional agents via the 351(k) pathway established under the Biologics Price Competition and Innovation Act (BPCIA), itself part of the Affordable Care Act (ACA). This past year has been especially busy in the space, with highlights including the launch of nine biosimilars of AbbVie Inc.’s Humira (adalimumab) and approvals of the first biosimilars of three different biologics: Biogen’s Tysabri (natalizumab), Actemra (tocilizumab) from Genentech USA, Inc., a member of the Roche Group and Stelara (ustekinumab) from the Janssen Pharmaceutical Companies of Johnson & Johnson. As the FDA approves more biosimilars, uptake of these agents will continue to increase, say industry experts.

“2023 was a banner year for the biosimilar market,” contends Andy Szczotka, Pharm.D., chief pharmacy officer at AscellaHealth. “The availability of biosimilars across multiple therapeutic areas provides opportunities for physicians, patients and payers to have additional clinical and cost-saving treatment choices.”

On March 23, 2010, then-President Barack Obama signed the Affordable Care Act (ACA) into law, establishing the 351(k) biosimilar pathway via the Biologics Price Competition and Innovation Act (BPCIA), which amended the Public Health Service (PHS) Act. Since then, the FDA has approved more than 40 biosimilars, with only a handful of those gaining interchangeable status. That designation, however, may not carry quite the distinction it historically has had if proposed guidance from the agency — which would replace previous guidance — on labeling for interchangeable biosimilars is finalized. At the same time, the change may help promote uptake of biosimilars, bringing cost savings to the U.S. health care system, say industry sources.

In contrast to the EU, whose European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) clarified in September 2022 that all biosimilars approved in the EU are interchangeable, the FDA has created two levels of biosimilars: biosimilars and interchangeable biosimilars.

Celltrion USA, Inc. signed a contract with Ventegra to include its Yuflyma (adalimumab-aaty) as a preferred drug on its formulary in both public and private insurance markets, the manufacturer said Oct. 5. Ventegra is a “major U.S. Medical Benefits Manager (MBM) who administers pharmacy benefits through its Pharmacy Services Administration (PSA) model that has been effectively displacing traditional” PBMs. The move gives Celltrion access to approximately 3.6% of the U.S. The company says it will increase its marketing so that the drug has “coverage and/or access for 40% of the U.S. population by the end of the year.” Yuflyma, a high-concentration biosimilar of AbbVie Inc.’s Humira (adalimumab), launched in July with a wholesale acquisition cost of $6,576. Celltrion also said that Yuflyma has been added to CarePartners Pharmacy’s cost savings programs. With its partners, the specialty pharmacy has access to more than 10 million plan members. It is fully accredited and licensed to service patients in all 50 states and Washington, D.C. According to The Korea Economic Daily, “CarePartners will sidestep the original Humira from its roster and refrain from enlisting other competing adalimumab biosimilars, effectively making Yuflyma the sole adalimumab product in its offerings.”

Since the FDA approved the first biosimilar — Zarxio (filgrastim-sndz) from Sandoz, then a division of Novartis Pharmaceuticals Corp. — on March 6, 2015, the agency has approved more than 40 additional agents via the 351(k) pathway established under the Biologics Price Competition and Innovation Act (BPCIA), itself part of the Affordable Care Act (ACA). This past year has been especially busy in the space, with highlights including the launch of nine biosimilars of AbbVie Inc.’s Humira (adalimumab) and approvals of the first biosimilars of three different biologics: Biogen’s Tysabri (natalizumab), Actemra (tocilizumab) from Genentech USA, Inc., a member of the Roche Group and Stelara (ustekinumab) from the Janssen Pharmaceutical Companies of Johnson & Johnson. As the FDA approves more biosimilars, uptake of these agents will continue to increase, say industry experts.

The FDA recently approved the first biosimilar of Actemra (tocilizumab) from Genentech USA, Inc., a member of the Roche Group, for multiple indications. Both payers and rheumatologists responding to a Zitter Insights survey said they expected the new drug to have some impact on their management of and prescribing for rheumatoid arthritis (RA). However, the drug’s lack of an additional formulation may hurt its uptake, say industry sources.

On Sept. 29, the FDA approved Bio-Thera and Biogen Inc.’s Tofidence (tocilizumab-bavi) intravenous formulation for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to at least one disease-modifying antirheumatic drug (DMARD), people at least 2 years old with active polyarticular juvenile idiopathic arthritis and people at least 2 years old with active systemic juvenile idiopathic arthritis. Dosing of the intravenous infusion is based on the indication.

The specialty drug landscape continues to be a dynamic space, as new agents enter the market and existing ones gain FDA approval for additional indications. Global health care and specialty pharmacy solutions organization AscellaHealth recently released its quarterly breakdown of insights into treatments within the segment.

The Q3 2023 Specialty & Rare Pipeline Digest examines new approvals and launches of specialty drugs, including biosimilars, generics, and cell and gene therapies, as well as ones in the pipeline.

Oct. 3: The FDA granted interchangeability to Biogen Inc. and Samsung Bioepis Co., Ltd.’s Byooviz (ranibizumab-nuna) for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization (mCNV). The agency first approved the biosimilar of Lucentis (ranibizumab) from Roche Group member Genentech USA, Inc. on Sept. 17, 2021. The vascular endothelial growth factor (VEGF) is administered by intravitreal injection once a month. Dosing for mCNV is up to three months. Drugs.com lists the price of a single-dose 10 mg/mL for 0.05mL vial as more than $1,199.

Oct. 11: The FDA expanded the approval of Fresenius Kabi’s Idacio (adalimumab-aacf) for the treatment of adults with moderate-to-severe hidradenitis suppurativa. The agency first approved the biosimilar of AbbVie Inc.’s tumor necrosis factor (TNF) blocker Humira (adalimumab) on Dec. 13, 2022. Dosing starts with 160 mg via subcutaneous injection on day one or split over two consecutive days, then 80 mg on day 15, and then on day 29 and subsequent doses, 40 mg every week or 80 mg every other week. The price of two single-dose prefilled pens or two single-dose prefilled glass syringes is $6,576.

When the Affordable Care Act (ACA) became law on March 23, 2010, it established the 351(k) biosimilar pathway via the Biologics Price Competition and Innovation Act (BPCIA), which amended the Public Health Service (PHS) Act. Since then, the FDA has approved more than 40 biosimilars, with only a handful of those gaining interchangeable status. That designation, however, may not carry quite the distinction it historically has had if proposed guidance from the agency — which would replace previous guidance — on labeling for interchangeable biosimilars is finalized. Various stakeholders, including manufacturers, pharmacies, patients and providers, stand to be affected, stakeholders say.

In contrast to the EU, whose European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) clarified in September 2022 that all biosimilars approved in the EU are interchangeable, the FDA has created two levels of biosimilars: biosimilars and interchangeable biosimilars.