One of the biggest events in the specialty pharmacy market is happening this year: the availability of biosimilars to AbbVie Inc.’s top-selling Humira (adalimumab). With its Jan. 31 launch, Amgen Inc.’s Amjevita (adalimumab-atto) was the first entrant, and others are expected this summer. But biosimilars of other top biologics also are coming down the pike. AIS Health, a division of MMIT, spoke with a variety of industry experts about what they’re watching in this space in 2023.
AIS Health: What kind of impact will be seen from the Humira biosimilars?
Nicole Kjesbo, Pharm.D., director of clinical program development for Prime Therapeutics LLC: Ideally, we’ll see price competition due to multiple biosimilars of Humira launching in 2023.
Elan Rubinstein, Pharm.D., principal at EB Rubinstein Associates: I expect Humira biosimilars’ market share to increase rapidly in 2023.…Not clear to me is whether, in 2023, major PBMs’ most common drug formularies will cover reference brand Humira and its biosimilars at parity or if some will disadvantage reference brand Humira relative to Humira biosimilars via “fail first” coverage policies or via preferential biosimilar drug tier (associated with a lower patient cost share).
Andy Szczotka, Pharm.D., chief pharmacy officer at AscellaHealth: The initial adalimumab biosimilar, Amjevita, is anticipated to be market available in late January 2023 and will be the exclusive adalimumab biosimilar for the first six months. The next adalimumab biosimilars are not anticipated to be market available until late June 2023, and then more are anticipated to be released in third- and fourth-quarter 2023. The initial impact with only a single biosimilar for the first half of 2023 is expected to be minimal since the product will only be available in the lower strength (50mg/ml), will not be interchangeable and is not latex-free. Since the majority of Humira use (i.e., more than 85%) is in the higher concentration strength (100mg/ml), Amjevita will only have a limited opportunity to capture market share and will likely be priced similarly or slightly below the branded Humira.
The impact of the adalimumab biosimilars will likely be more significant in the third and fourth quarters of 2023 with the introduction of multiple other manufacturers (potentially up to 11 different products, depending upon FDA approval), product interchangeability, product concentration, availability as citrate- and latex-free formulations and expected lower pricing. Payers will likely be narrowing their potential choices of adalimumab formulations to assist with lowering the cost of the product for the patient and their clients. Their choices will be based on these various factors, net cost and product availability.
An additional benefit likely seen with the introduction and adoption of the adalimumab biosimilars will be having the physicians and providers gain a broader understanding and familiarity with biosimilars as an additional clinically and cost-effective tool to help stretch the limited health care dollar for patients and payers. As other key biosimilars are launched in 2023 and 2024, this should help with their market adoption.
Mesfin Tegenu, CEO and chairman of RxParadigm, Inc.: The launch of Humira biosimilars may lead to an increased adoption of biosimilars. To date, most biosimilar launches have been for provider-administered drugs and did not requiring significant formulary management changes, as they were medical benefit products. However, Humira biosimilar management may impact the cost and management of other high-cost disease-modifying antirheumatic drugs (DMARDs), potentially leading to changes in formulary tiering and utilization management to promote their use. More payer adoption of biosimilars is expected to emerge; consequently, there will be an upward trend of biosimilar utilization and uptake.
Winston Wong, Pharm.D., president of W-Squared Group: Simply said, it all comes down to net cost while maximizing margins. Biosimilars will increase competition and create pressure to lower cost, and everyone will have to come to the table. Amgen has already that they will be releasing the same pen device at a 5% and 55% discount. Obviously the 5% discount product will be offered to the PBMs at a deeper discount, thus meeting the needs of low net cost and maximized margin. Thus, how will this impact and benefit patent affordability? My guess is that it will not. Everyone except the patient will win here.
AIS Health: Besides the adalimumabs’ launches, what do you expect we’ll see within the biosimilars landscape this year?
Kjesbo: Additional biosimilars are expected to enter the market in 2023 for Avastin [(bevacizumab) from Genentech USA, Inc., a member of the Roche Group], Herceptin [(trastuzumab) from Genentech], Neulasta [(pegfilgrastim) from Amgen Inc.] and Lucentis [(ranibizumab) from Genentech].
Rubinstein: Biosimilar to Stelara [(ustekinumab) from Johnson & Johnson unit Janssen Biotech, Inc.] has a planned launch in September 2023.
Szczotka: The biosimilar landscape will have a large shift in 2023 due to the adalimumab launches. This will impact the overall acceptance of biosimilars moving forward. To date, the overall acceptance of biosimilars in the U.S. has been slow as compared to some European countries. However, over time, we are seeing a gradual increase in the year-to-year acceptance and use of the currently available U.S. biosimilar agents. This will be aided indirectly by the adalimumab biosimilar launches.
The biosimilar landscape will also continue to expand into existing and new therapeutic classes such as ophthalmology, oncology and immunology. In ophthalmology, there are two biosimilars to Lucentis: Byooviz [(ranibizumab-nuna) from Samsung Bioepis Co., Ltd. and Biogen Inc.], which was launched in July 2022, and Cimerli [(ranibizumab-eqrn) from Coherus BioSciences, Inc.], which is an interchangeable biosimilar launched in October 2022. Two additional biosimilars to Lucentis are in Phase III trials and expected to seek approval within the next two years. Additionally, there are at least nine biosimilars to Eylea [(aflibercept) from Regeneron Pharmaceuticals, Inc.] which are in various stages of development, and the first biosimilar approval is expected in 2023.
Immunology biosimilars are anticipated to expand and will include the TNF [i.e., tumor necrosis factor] inhibitors such as Stelara, Simponi [(golimumab) from Janssen] and Cimzia [(certolizumab pegol) from UCB, Inc.]. Stelara will lose exclusivity this year, but there are currently no biosimilars that have yet been FDA approved. Nine biosimilars are in the pipeline for Stelara, with two pending FDA approval in 2023. In addition to Stelara, Simponi and Cimzia will lose exclusivity in 2024, and currently the development for biosimilars for each is underway, with a potential launch in 2024. Actemra [(tocilizumab) from Genentech] is another biologic that has two potential biosimilar launches in 2023.
The oncology area will see additional biosimilars this year as well. Three biosimilars to cancer supportive care biologics were approved by the FDA in 2022, and [two of] their U.S. launches are expected in 2023. They include…[Amneal Pharmaceuticals, Inc.’s] Fylnetra (pegfilgrastim-pbbk) and [Fresenius Kabi’s] Stimufend (pegfilgrastim-fpgk), [which launched on Feb. 6, just before AIS Health’s press time,] both Neulasta biosimilars. There will be much more competition for products such as Avastin, Herceptin and Rituxan [(rituximab) from Genentech and Biogen] in the coming year, with potentially [an additional] six biosimilars for Avastin, five for Herceptin and four for Rituxan.
The trend upward is expected to continue and, as a result, will provide additional product options to enhance choices to life-saving biologics while enhancing cost-saving opportunities.
Tegenu: The biosimilar landscape will continue to see a rising number of launches this year. Biosimilars projected to launch this year include Stelara, Actemra, Novolog [(insulin aspart) from Novo Nordisk] and Tysabri [(natalizumab) from Biogen]. In addition, more biosimilars to Neulasta, Herceptin and Lantus [(insulin glargine) from Sanofi] are projected to launch in 2023. The growing pipeline of approvals and launches will further drive biosimilar utilization and cost savings.
Wong: This is from the IQVIA report on biosimilars that was just released: “The 21 molecules with biosimilars in development that are still protected generated $89Bn in sales in 2021 and averaged $4.2Bn. This includes the immunology blockbusters adalimumab (Humira) and ustekinumab (Stelara), which accounted for 40% of this spending and will lose exclusivity in 2023.”
“By the end of 2023, at least 10 of the currently approved biosimilars are expected to launch, with eight of these being biosimilars for adalimumab (Humira), which will lose exclusivity in January 2023. The remaining 2 launches are anticipated for ustekinumab (Stelara).”
Thus,...the immunologic market is slated to become very crowded with 10 biosimilar launches anticipated, along with novel agents coming to market. The question is whether the release of the biosimilars results in any cost savings to the patient. We know there are savings by health plans, but if we start to see more strategies where list prices are only slightly discounted and pull in bigger rebates, who is that really benefiting? Patients are still experiencing financial toxicity.
Contact Kjesbo through Jenine Anderson at jenine.anderson@primetherapeutics.com, Rubinstein at elan.b.rubinstein@gmail.com, Szczotka through Caroline Chambers at cchambers@cpronline.com, Tegenu at Mesfin.Tegenu@rxparadigm.com and Wong at w2sqgroup@gmail.com.
By Angela Maas