Specialty Drugs

The FDA recently expanded the indication of AbbVie Inc.’s Rinvoq (upadacitinib), making it the first oral treatment for Crohn’s disease. And while respondents to a Zitter Insights survey said the drug will somewhat lessen the unmet need in the treatment of the condition, they said that a moderate level of need still exists with the agent’s approval.

On May 18, the FDA expanded the label of Rinvoq to include the treatment of adults with moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to at least one tumor necrosis factor (TNF) inhibitor. The agency initially approved the Janus kinase (JAK) inhibitor on Aug. 16, 2019. This is the seventh indication the drug has gotten across rheumatology, dermatology and gastroenterology.

With an eye on improving medication adherence for people with rare diseases or chronic conditions, AllianceRx Walgreens Pharmacy recently launched RightGuide. The program helps digitally connect pharma manufacturers to patients and their caregivers in order to provide education on a variety of topics, from training people how to self-administer injectable agents to helping with financial issues and addressing the side effects of medications.

The specialty pharmacy is working with manufacturers to create customized, brand-specific resources “to help facilitate patient conversion, adherence and retention — while minimizing treatment barriers for patients and caregivers,” explains Tracey James, R.Ph., chief operating officer at AllianceRx Walgreens Pharmacy.

Amneal Pharmaceuticals, Inc. launched Fylnetra (pegfilgrastim-pbbk), the company said May 16. The granulocyte colony-stimulating factor is the sixth biosimilar of Amgen Inc.’s Neulasta (pegfilgrastim) to launch in the U.S. The FDA approved the drug on May 26, 2022, to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Its J-code is Q5130. It is the third biosimilar that Amneal has launched in the U.S.

Amgen settled a patent infringement lawsuit (No. 22-cv-1549) with Janssen Biotech Inc., a division of Johnson & Johnson, over a proposed biosimilar of Stelara (ustekinumab), Amgen revealed May 23. Stelara, a human interleukin-12 and -23 antagonist, is indicated for adults with moderate-to-severe plaque psoriasis, moderately to severely active Crohn’s disease and moderately to severely active ulcerative colitis, as well as people at least 6 years old with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy and people at least 6 with active psoriatic arthritis. The FDA first approved it on Sept. 25, 2009. Amgen said the settlement will allow its biosimilar to launch “no later than” Jan. 1, 2025.

Various randomized controlled trials have found that hypofractionated whole breast irradiation (HF-WBI) for certain patients with early-stage breast cancer is not only equivalent to standard radiation therapy for local control of the disease but also is less toxic, has better patient adherence and provides improved patient well-being. Those results led the National Comprehensive Cancer Network (NCCN) to add the approach to its guidelines. But while hypofractionation can benefit patients, providers and health plans, there has been slow uptake of it. A recent study found that putting clinical pathways in place that include mandating HF-WBI’s use improved compliance with the guidelines.

One retrospective study found that health plans spent $6,375 less for HF-WBI than they spent on conventional whole breast irradiation, and patients saved about $140 aside from travel-related costs.

One manufacturer recently revealed that it would launch its biosimilar of AbbVie Inc.’s Humira (adalimumab) at a huge discount not seen before in the U.S. While it almost certainly will be able to get some uptake in a market that’s about to become highly competitive, commercial payers who favor high list price/high rebate therapies are likely to not cover the agent, say industry experts.

On June 1, Coherus BioSciences, Inc. revealed that it would launch Yusimry (adalimumab-aqvh) in July with a list price of $995 per carton — an 85% discount off reference drug Humira’s (adalimumab) $6,922 price tag. The tumor necrosis factor (TNF) inhibitor, first approved Dec. 17, 2021, is a low concentration, citrate-free version of Humira, and it has approval for most of the reference drug’s indications: (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.

May 9: The FDA approved Chiesi Group unit Chiesi Global Rare Diseases and Protalix BioTherapeutics, Inc.’s Elfabrio (pegunigalsidase alfa-iwxj) for the treatment of adults with Fabry disease. A PEGylated enzyme replacement therapy, the agent is a recombinant human α–Galactosidase–A enzyme expressed in plant-cell culture that is designed to provide a long half-life. Recommended dosing is 1 mg/kg via intravenous infusion every two weeks.

May 17: The FDA approved a 40 mg/0.8 mL single-dose autoinjector for Boehringer Ingelheim’s Cyltezo (adalimumab-adbm). The agency initially approved the biosimilar of AbbVie Inc.’s Humira (adalimumab) on Aug. 25, 2017, as a single-use prefilled syringe. The drug is approved for multiple chronic inflammatory diseases. The new pen will be available in two-, four- and six-pack options when the tumor necrosis factor (TNF) inhibitor launches on July 1.

The FDA recently approved an expanded patient population for Novo Nordisk’s Sogroya (somapacitan-beco), a long-acting growth hormone requiring weekly administration, as opposed to daily administration of short-acting agents. Payers and endocrinologists have expressed a willingness to manage and prescribe the new agents, according to Zitter Insights. Nevertheless, this is a class where agents have not shown clinical differentiation, so payer coverage of the agents likely will come down to cost, industry experts say.

On April 28, the FDA expanded the patient population for Sogroya to include the treatment of people at least 2 1/2 years old who have growth failure due to inadequate secretion of endogenous growth hormone. The agency initially approved the drug on Aug. 28, 2020, for the replacement of growth hormone in adults with growth hormone deficiency. With the newest approval, the injectable becomes the first and only once-weekly growth hormone treatment for both children and adults.

The FDA has so far approved nine biosimilars of AbbVie Inc.’s Humira (adalimumab), and all of them — as well as 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.

The traditional pharmacy benefit market is seeing a challenge to its model from patient-paid prescriptions, contended longtime industry expert Adam J. Fein, Ph.D., CEO of Drug Channels Institute, during a recent webinar. While some generics of specialty drugs are being sold via these routes, the potential exists for disruption in crowded biologic-treated classes facing a lot of competition, particularly via biosimilars.

And with some industry developments such as the Inflation Reduction Act likely to impact the uptake of high-price/high-rebate drugs, patient-paid prescriptions could become an even bigger disruption within the market than they already are.

With an eye on improving medication adherence for people with rare diseases or chronic conditions, AllianceRx Walgreens Pharmacy recently launched RightGuide. The program helps digitally connect pharma manufacturers to patients and their caregivers in order to provide education on a variety of topics, from training people how to self-administer injectable agents to helping with financial issues and addressing the side effects of medications.

The specialty pharmacy is working with manufacturers to create customized, brand-specific resources “to help facilitate patient conversion, adherence and retention — while minimizing treatment barriers for patients and caregivers,” explains Tracey James, R.Ph., chief operating officer at AllianceRx Walgreens Pharmacy.