Drug Approvals

Over the last few years, the FDA has taken multiple steps to level the playing field between biosimilars and interchangeable biosimilars. More recently, it proposed draft guidance that would do away with switching studies for interchangeability status. Commenters on that guidance were mostly supportive — with some even backing interchangeability for all biosimilars — and others asked for clarification on a range of issues, including what information the FDA needed to make a determination of interchangeability. Meanwhile, one group derided the guidance as an “ill-advised and inappropriate move.”

Aug. 7: The FDA approved Citius Pharmaceuticals, Inc.’s Lymphir (denileukin diftitox-cxdl) for the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one systemic therapy. The immunotherapy is the only CTCL treatment that targets the interleukin-2 (IL-2) receptor found in T-cell lymphomas and regulatory T cells (Tregs). The rare disease is a chronic non-Hodkin lymphoma that primarily affects the skin. The drug is a reformulation of Ontak (denileukin diftitox), which was on the U.S. market from 2008 to 2014, when it was voluntarily withdrawn “to enable manufacturing improvements.” The FDA gave the therapy orphan drug designation. The recommended dose is 9 mcg/kg per day based on actual body weight via a 60-minute intravenous infusion on days one through five of a 21-day cycle. The company says it expects to launch the agent within the next five months.

In recent years, commercial health plans have increasingly opted to place both biosimilars and their reference biologics on preferred tiers in their formularies, according to a recent Health Affairs study.

The researchers analyzed coverage and market share for seven biologics — also known as “originator products” — and 20 corresponding biosimilars from the Tufts Medical Center Specialty Drug Evidence and Coverage Database and the IQVIA Longitudinal Access and Adjudicated Data Set from August 2017 to August 2022.

As President Joe Biden’s administration nears its end, two promised rules on copayment accumulators and maximizers have yet to be released. They stand to have a huge impact on whether pharma manufacturer-provided patient assistance — much of which is provided for specialty drugs — must be counted toward patients’ out-of-pocket responsibility.

The first concerns a lawsuit over the 2021 Notice of Benefit and Payment Parameters (NBPP) and its stance toward copay accumulators.

Health plans and PBMs several years ago began implementing accumulators to counter manufacturer copay assistance programs. Traditionally, that assistance would count toward beneficiaries’ annual out-of-pocket expenses. When those out-of-pocket maximums were reached, health plans would cover the remainder of members’ costs for the year. With accumulators, patients can still use that assistance, but it does not help reduce their out-of-pocket costs.

With policymakers and industry stakeholders increasingly focused on the cost savings opportunities tied to biosimilars, a new Health Affairs study sheds light on some of the factors that influence uptake of these near-copies of pricey biologic medications.

Among almost 200,000 commercial and Medicare Advantage enrollees who newly initiated one of seven biologic drugs with available biosimilar versions — filgrastim, bevacizumab, epoetin alfa, trastuzumab, pegfilgrastim, infliximab and rituximab — the share of people initiating a biosimilar increased from 1% in 2013 to 34% in 2022. Patients who were younger than 18 years were less likely to initiate a biosimilar than other age groups. Meanwhile, enrollees in commercial high-deductible health plans were more likely to use a biosimilar, compared with those in MA plans.

A newly approved immune globulin for primary immunodeficiency will bring another option to a class of products that often is plagued by shortages. It is also a crowded space, and payers have several considerations when deciding on the coverage of these agents, say industry experts.

On June 13, the FDA approved Grifols Group company Biotest AG’s Yimmugo (immune globulin intravenous, human-dira) for the treatment of primary humoral immunodeficiency in people at least 2 years old. Dosing via intravenous infusion is every three to four weeks, with the first infusion started at 0.5 mg/kg per minute and increasing up to 3.0 mg/kg per minute; afterwards, the maintenance infusion rate is 13 mg/kg per minute. The dosage can be adjusted over time to achieve the desired trough levels and clinical response.

With policymakers and industry stakeholders increasingly focused on the cost savings opportunities tied to biosimilars, a new Health Affairs study sheds light on some of the factors that influence uptake of these near-copies of pricey biologic medications.

Among almost 200,000 commercial and Medicare Advantage enrollees who newly initiated one of seven biologic drugs with available biosimilar versions — filgrastim, bevacizumab, epoetin alfa, trastuzumab, pegfilgrastim, infliximab and rituximab — the share of people initiating a biosimilar increased from 1% in 2013 to 34% in 2022. Patients who were younger than 18 years were less likely to initiate a biosimilar than other age groups. Meanwhile, enrollees in commercial high-deductible health plans were more likely to use a biosimilar, compared with those in MA plans.

July 8: The FDA approved ANI Pharmaceuticals, Inc.’s L-glutamine oral powder to reduce the acute complications of sickle cell disease in people at least 5 years old. The company says it is the first AA-rated approved generic for Emmaus Medical, Inc.’s Endari. Dosing for people weighing less than 30 kilograms is one packet twice daily; for those between 30 and 65 kilograms, dosing is two packets twice daily, and for those more than 65 kilograms, dosing is three packets twice daily. Drugs.com lists the price of 60 packets of Endari as more than $1,505.

Although the approval of Kisunla (donanemab) earlier this month was celebrated by the Alzheimer’s Association as “real progress,” the challenge of getting commercial insurers to cover the drug will likely end up tempering that excitement.

Eli Lilly’s Kisunla, which received full FDA approval on July 2, is a once-monthly, IV-infused treatment for people with early symptoms of Alzheimer’s disease, including mild cognitive impairment and mild dementia. Like the drug Leqembi (lecanemab), which received full approval last July, Kisunla aims to slow the progression of Alzheimer’s by removing amyloid plaques from the brain. (The naturally occurring protein amyloid can create plaques when clumped together, and if those plaques build up excessively in the brain, it may lead to memory and cognitive issues associated with Alzheimer's disease.)

Beginning on July 18, Boehringer Ingelheim will offer its citrate-free Cyltezo (adalimumab-adbm), an interchangeable biosimilar to Humira (adalimumab), at a low cash price available exclusively on the GoodRx website, according to a press release. Both high- and low- concentration versions of the biosimilar, administered in either auto-injectors or pre-filled syringes, will be available at a price of $550 per two pack, a 92% discount from the Humira list price.

Following the launch of Amgen Inc.’s Amjevita (adalimumab-atto), another nine FDA-approved Humira biosimilars entered the U.S. market. Most recently, Teva Pharmaceuticals, a unit of Teva Pharmaceuticals Industries Ltd., and Alvotech launched Simlandi (adalimumab-ryvk) in May. The FDA approved the interchangeable, high-concentration, citrate-free drug in February for nine of its reference drug’s indications.