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Aam Exec: Biosimilar Growth Is Impressive, but New Policies Are Required

Biosimilar Growth
However, pricing of the new biosimilar is unclear. The exact cost savings will be an important factor in whether the biosimilar gains acceptance and becomes commonly prescribed, Williams said.

Three pieces of legislation that would provide incentives to prescribers and put generics and biosimilars in favorable formulary tiers would speed further prescribing and use of biosimilars, Christine Simmon told Managed Healthcare Executive.®

The prescribing of generic drugs and biosimilars that are less expensive than their brand-name counterparts saved U.S. healthcare system almost $340 billion in spending in 2020 according to the Association for Accessible Medicines (AAM), a trade association for generic and biosimilar makers.

The AAM said that biosimilar drugs saved $7.9 billion in 2020, more than tripling the $2.5 billion saved in 2019. “This growth demonstrates prescriber and payer confidence in the safety and efficacy of FDA-approved biosimilars and their ability to provide greater access to treatments at a savings for patients,” Christine Simmon, executive vice president of policy and strategic alliances at AAM and executive director of the organization’s Biosimilars Council, told Managed Healthcare Executive®.

However, biosimilars were still less than 30% volume share in markets where they competed, Simmon noted. “As more biosimilars are approved and brought to market, patients and taxpayers will save billions while treating serious illnesses like cancer and Crohn’s disease,” she predicted.

The full promise of savings through biosimilar competition will only be realized if policymakers take steps to foster greater biosimilar adoption, Simmon added.

For example, the BIOSIM Act (H.R. 2815) would make changes to reimbursement to incentivize the use of biosimilars, Simmon told MHE. “Currently, providers in Medicare Part B are reimbursed for administering biosimilars at the biosimilar’s average sales price (ASP), plus 6% of the brand-name biologic. The BIOSIM Act…would increase reimbursement for biosimilars by 2% to ASP+8% and would apply only when the biosimilar’s ASP is lower than the brand-name biologic’s ASP.”

The Increasing Access to Biosimilars Act (S. 1427/H.R. 2869), which directs the CMS to establish a voluntary, national demonstration project under Medicare Part B to evaluate the benefit of providing a shared savings payment for biosimilars, could also incentivize the use of biosimilars.

“Under this model, participating providers would receive a portion of the savings for prescribing a biosimilar with a lower ASP than the reference biologic,” Simmon said.

Meanwhile, the Ensuring Access to Lower-Cost Medicines for Seniors Act (H.R. 2846) would ensure that seniors are able to access and fully benefit from low-cost generics and biosimilars through the Medicare Part D program. “This bill…ensures that new generics and biosimilars are covered upon launch, provides that generics are placed only on generic tiers with lower cost-sharing and not higher brand cost-sharing tiers, and establishes a new specialty tier for biosimilars and specialty generics,” Simmon added.

Generic drug produced significant out-of-pocket savings for individual patients at the pharmacy counter, according to AAM. Almost all (93%) of generic drugs have copays under $20 (as compared to 51% of brand-name drugs) and the average generic copay is $6.61 compared to an average out-of-pocket cost of $55.82 for brand-name drugs, the trade group says.

Medicare recorded $109.6 billion in generic and biosimilar savings in 2020, while Medicaid saved $53.8 billion.

AAO Spokesperson: FDA Approval of Byooviz, First Biosimilar to Lucentis, Is “Significant”

Exactly how Byooviz will be priced is unclear, noted George W. Williams, M.D., a retina specialist and past president of the American Academy of Ophthalmology. The exact cost savings will help determine whether the biosimilar gains acceptance.

The FDAapproval of the first biosimilar to Roche’s blockbuster drug Lucentis for neovascular (wet) age-related macular degeneration (AMD) and other eye diseases is definitely significant, according to George A. Williams, M.D., a clinical spokesperson for the American Academy of Ophthalmology.

The biosimilar, Byooviz (ranibizumab-nuna), was approved by the FDA last month as a treatment of AMD, macular edema following retinal vein occlusion, and myopic choroidal neovascularization.

Byooviz’s approval is “significant” because it is the first FDA-approved biosimilar for an ophthalmic indication, and “it’s a biosimilar for one of the most popular and effective therapies we have in the ophthalmic space,” noted Williams in a recent interview Managed Healthcare Executive.® Williams, a retina specialist and former president of the American Academy of Ophthalmology, is chair of the department of ophthalmology and director of the Beaumont Eye Institute at Beaumont Health in Royal Oak, Michigan.

Byooviz is the first ophthalmology biosimilar approved in the U.S, but it won’t be available in the U.S. till June 2022 because of a global licensing agreement with Genentech, which is part of Roche. The Lucentis biosimilar was developed by Samsung Bioepis, a Korean company but will be marketed by Biogen in the U.S. as Byooviz.

The approval and marketing Byooviz is expected to cut into the U.S. sales of Lucentis, which came to $363 million in the U.S. in the second quarter of 2021.

Before Lucentis was approved in 2006, 90% of people who developed wet AMD would be legally blind within one year, Williams noted. “This therapy completely reversed that. Now, less than 10% of people with wet AMD will end up legally blind if starting appropriate treatments.”

“The approval of the first ranibizumab biosimilar in the US is a monumental milestone for people living with retinal vascular disorders in the US,” said Kyung-Ah Kim, senior vice president and development division leader at Samsung Bioepis, in a press release issued jointly by the Korean company and Biogen

About 11 million Americans live with AMD and the prevalence of advanced AMD is increasing because of the aging U.S. population, noted the Samsung Bioepis and Biogen.

“Biosimilars could help broaden patient access to more affordable treatments and generate health care savings to offset rising costs of these complex diseases while ensuring sustainability of healthcare systems,” Ian Henshaw, senior vice president and global head of Biosimilars at Biogen, said in a press release when the approval was announced.

However, pricing of the new biosimilar is unclear. The exact cost savings will be an important factor in whether the biosimilar gains acceptance and becomes commonly prescribed, Williams said.

“As physicians, the American Academy of Ophthalmology has always believed that more treatments options that benefit patients out there is a good thing. We’re fortunate to have three FDA-approved and one off-label anti-VEGF available and it will take some time to sort out how this biosimilar will benefit patients,” Williams added.

European and British drug regulators approved Byooviz in August.

The FDA has approved four other biosimilars developed by Samsung Bioepis: Renflexis (infliximab-abda), Ontruzant (trastuzumab-dttb), Eticovo (etanercept-ykro) and Hadlima (adalimumab-bwwd).