Slew of Adalimumab Biosimilars Are Expected in July

The FDA has so far approved nine biosimilars of AbbVie Inc.’s Humira (adalimumab), and all of their manufacturers — as well as those for some others in the pipeline — have settled patent litigation with AbbVie that allows them to launch onto the U.S. markets by a certain date.

But it’s not just the launch dates that are different. Some are low-concentration versions of Humira, while some are high-concentration versions, the latter of which has about 85% of current Humira prescribing. The FDA approved a high-concentration, citrate-free version of Humira in November 2015, but AbbVie waited until July 2018 to launch it. This formulation requires half the volume of drug injected compared with the original formulation, and it has fewer excipients that often cause discomfort when injected, as well as a thinner needle.

But when manufacturers of potential Humira competitors began developing their biosimilars, they were developing lower concentration versions based on the original formulation. “Defense strategy” against biosimilars was one of the reasons for the gap between approval and launch of the new version, asserted a staff report from the U.S. House of Representatives’ Committee on Oversight and Reform released in May 2021.

In addition to concentration, other distinctions include citrate-free, latex-free, type of device, needle gauge and interchangeability status. A recent report from Cardinal Health revealed that gastroenterologists, rheumatologists and dermatologists differed a bit in which of those characteristics were most important to them. Many of the agents that already have been approved are seeking additional approvals for attributes like high concentration and interchangeability.

One of the biosimilars is already on the market: On Jan. 31, Amgen Inc.’s Amjevita (adalimumab-atto) launched at two different wholesale acquisition costs — one 55% below Humira’s WAC and one 5% below it. The drug is a low-concentration, citrate-free version of Humira that is approved for most of the same indications as Humira: (1) adults with moderately to severely active rheumatoid arthritis, (2) people at least 2 years old with moderately to severely active juvenile idiopathic arthritis, (3) adults with active psoriatic arthritis, (4) adults with active ankylosing spondylitis, (5) people at least 6 years old with moderately to severely active Crohn’s disease, (6) adults with moderately to severely active ulcerative colitis, (7) adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy and when other systemic therapies are medically less appropriate, and (8) adults with moderate to severe hidradenitis suppurativa.

Multiple biosimilars are expected to come onto the market next month, and the pricing strategy for one of them was recently unveiled. Coherus BioSciences, Inc. said June 1 that its Yusimry (adalimumab-aqvh) recently will launch in July with a list price of $995 per carton — an 85% discount off reference drug Humira’s (adalimumab) $6,922 price tag. The agent is low-concentration and citrate-free and has approval for the same indications as Amjevita. Coherus also revealed that that it will offer Yusimry through Mark Cuban Cost Plus Drug Company, which will sell the drug for $569.27 plus dispensing and shipping fees, making it the first biologic that the company has sold.

AIS Health, a division of MMIT, reached out to the other manufacturers with potential July launches for details on pricing and launch time frames.

A Boehringer Ingelheim spokesperson said the company would launch Cyltezo (adalimumab-adbm) on July 1. The drug is the only interchangeable Humira so far, and it is low-concentration and citrate-free, with the same indications as Yusimry.

“While we cannot comment directly on the WAC cost until Cyltezo is commercially available on July 1, we can confirm that Cyltezo will be priced competitively to other biosimilars approved by the FDA,” says the spokesperson. “Additionally, we are actively working with payers to gain broad formulary access for when Cyltezo launches later this summer.”

A Celltrion USA spokesperson says that the launch of Yuflyma (adalimumab-aaty) is scheduled for “early July,” and that the drug’s price will be revealed at that time. The drug is a high-concentration, citrate-free biosimilar with Yusimry’s eight indications. The company is seeking an interchangeability designation, which could come in fourth-quarter 2024.

Organon & Co. said that it will launch Hadlima (adalimumab-bwwd) — which is citrate-free and available in both high and low concentrations — on July 1, and its price will be disclosed at that time. It has seven of Yusimry’s indications, lacking one for hidradenitis suppurativa.

A Pfizer Inc. spokesperson says that the company plans to launch Abrilada (adalimumab-afzb) “as a citrate-free and latex-free biosimilar…late third-quarter/early fourth-quarter 2023. Upon launch, Pfizer expects to offer Abrilada at a competitive price. We will provide additional details on pricing in the coming months.” The agent has the same indications as Hadlima.

In February 2022, Pfizer disclosed that the FDA had accepted its application for interchangeability, with a decision expected in fourth-quarter 2022. When asked about the status of that application, the spokesperson said that “the FDA completed its review of Pfizer’s application in the fourth quarter of 2022 and provisionally determined that Abrilada met the standards as an interchangeable biosimilar to Humira (adalimumab). The FDA has not provided a time frame for the anticipated approval, but Pfizer is continuing to work with the agency to understand its perspective in the context of its guidance on interchangeability and determine a path forward.”

Not responding to AIS Health’s request for comment were three companies:

• Novartis Pharmaceuticals Corp., whose now-division Sandoz (which will be spun off into a new publicly traded standalone company in the second half of this year) is set to launch Hyrimoz (adalimumab-adaz) in both high- and low-concentration, citrate-free versions. The agent has the same indications as Hadlima. Novartis previously said that the drug will launch July 1.
• Fresenius Kabi, which will launch the low-concentration, citrate-free Idacio (adalimumab-aacf) that has Hadlima’s indications.
• Biocon Biologics Limited, which will launch the low-concentration, citrate-free Hulio (adalimumab-fkjp) that has Yusimry’s indications.

So what will be the most important attributes for uptake?

“With so many biosimilars launching at once, name recognition and comfort with the product will be a key factor,” says Dan Danielson, R.Ph., senior director of the access experience team at PRECISIONvalue. “Since most of the products are launching as noninterchangeable, physicians will need to write for the specific brand of adalimumab they want; if the physician doesn’t know the product, they cannot write for it.”

Cyltezo, he says, “may have a leg up, but here, too, name recognition and some product knowledge will be required by physicians. Patients will also have a part to play: They will need to be aware and engaged enough to ask their physician. Assuming adalimumab remains largely dispensed by specialty pharmacies, processes for dispensing their favored product in lieu of others will need to be established, which hopefully have been planned out by now.”

Renee Rayburg, R.Ph., vice president of specialty clinical consulting at Pharmaceutical Strategies Group (PSG), an EPIC company, cites formulary coverage as the most important factor for uptake. “For those PBMs that will continue to cover brand Humira in a preferred position, I am not sure how much impact covering the biosimilars will have. However, transparency in pricing and low list prices seem desirable by some payers. Will that be enough to force some strategies to prefer a biosimilar? Time will tell, but as I have long said, the presence of biosimilars alone can create competition that leads to lower prices for all products, which is a step in the right direction to start to take advantage of savings for this long-time No. 1 spend for payers. There are a finite number of health care dollars, so many payers are interested in any/all strategies that can lead to savings.”

According to Andy Szczotka, Pharm.D., chief pharmacy officer at AscellaHealth, “to gain a portion of the current adalimumab market share, ideally adalimumab biosimilars need to have availability of both the low- and high-concentration products, have an interchangeable designation, be citrate- and latex-free, have a convenient injection device and the ability to supply the market to avoid any patient disruptions. In addition, the available pricing, both in terms of list prices and net pricing, including available discounts, will all contribute to the decision process for payers.”

Multiple competitors within the space will “increase pressure on launch price, on negotiated net price and on the erosion of both list and net over time,” states Elan Rubinstein, Pharm.D., principal at EB Rubinstein Associates. “But while rebate maximization may prevail today, PBMs’ traditional rebate-driven business model is under increasing pressure due to ‘transparent’ (aka pass-through) PBMs and due to current Congressional investigations into PBM business practices. Regardless of uptake of one or another adalimumab brand, adalimumab price erosion will prevail. In turn, because adalimumab is dominant in this therapeutic category, its price erosion will increasingly pressure pricing of therapeutically competitive reference brands and biosimilars.”

Szczotka says he expects the biosimilars will have different strategies to gain market share, with some following Coherus’ lead and having “a low-cost strategy to boost sales outside of the traditional channels. This will especially be true if they are unable to offer any market differentiators such as interchangeability, the availability of a high-concentration formulation or offer patient support programs. Other manufacturers will follow a more traditional marketing approach. They will offer a discount to the reference product Humira, but it is unlikely to be as steep as the 85% discount offered by Coherus. Regardless, a clearer picture of the adalimumab market will play out early in the third quarter of 2023.”

Contact Danielson via Asha Strazzero-Wild at Asha.Strazzero-Wild@precisionvh.com, Rayburg via Betsy Van Alstyne at Betsy.VanAlstyne@psgconsults.com, Rubinstein at elan.b.rubinstein@gmail.com and Szczotka via Caroline Chambers at cchambers@cpronline.com.

By Angela Maas