FDA

Oct. 3: The FDA granted interchangeability to Biogen Inc. and Samsung Bioepis Co., Ltd.’s Byooviz (ranibizumab-nuna) for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization (mCNV). The agency first approved the biosimilar of Lucentis (ranibizumab) from Roche Group member Genentech USA, Inc. on Sept. 17, 2021. The vascular endothelial growth factor (VEGF) is administered by intravitreal injection once a month. Dosing for mCNV is up to three months. Drugs.com lists the price of a single-dose 10 mg/mL for 0.05mL vial as more than $1,199.

Oct. 11: The FDA expanded the approval of Fresenius Kabi’s Idacio (adalimumab-aacf) for the treatment of adults with moderate-to-severe hidradenitis suppurativa. The agency first approved the biosimilar of AbbVie Inc.’s tumor necrosis factor (TNF) blocker Humira (adalimumab) on Dec. 13, 2022. Dosing starts with 160 mg via subcutaneous injection on day one or split over two consecutive days, then 80 mg on day 15, and then on day 29 and subsequent doses, 40 mg every week or 80 mg every other week. The price of two single-dose prefilled pens or two single-dose prefilled glass syringes is $6,576.

When the Affordable Care Act (ACA) became law on March 23, 2010, it established the 351(k) biosimilar pathway via the Biologics Price Competition and Innovation Act (BPCIA), which amended the Public Health Service (PHS) Act. Since then, the FDA has approved more than 40 biosimilars, with only a handful of those gaining interchangeable status. That designation, however, may not carry quite the distinction it historically has had if proposed guidance from the agency — which would replace previous guidance — on labeling for interchangeable biosimilars is finalized. Various stakeholders, including manufacturers, pharmacies, patients and providers, stand to be affected, stakeholders say.

In contrast to the EU, whose European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) clarified in September 2022 that all biosimilars approved in the EU are interchangeable, the FDA has created two levels of biosimilars: biosimilars and interchangeable biosimilars.

The FDA recently approved the first biosimilar of Actemra (tocilizumab) from Genentech USA, Inc., a member of the Roche Group, for multiple indications. Both payers and rheumatologists responding to a Zitter Insights survey said they expected the new drug to have some impact on their management of and prescribing for rheumatoid arthritis (RA).

On Sept. 29, the FDA approved Bio-Thera and Biogen Inc.’s Tofidence (tocilizumab-bavi) intravenous formulation for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to at least one disease-modifying antirheumatic drug, people at least 2 years old with active polyarticular juvenile idiopathic arthritis and people at least 2 years old with active systemic juvenile idiopathic arthritis. Dosing of the intravenous infusion is based on the indication.

Boehringer Ingelheim’s adalimumab-adbm interchangeable biosimilar is now available at an 81% discount to the price of its reference drug, AbbVie Inc.’s Humira (adalimumab), the manufacturer said Oct. 2. In early July, the company launched a branded version of the agent, Cyltezo, at a 5% discount. Both are citrate-free formulations available in various strengths for multiple inflammatory conditions.

Takeda Pharmaceuticals U.S.A., Inc. will voluntarily withdraw Exkivity (mobocertinib) after the Phase III EXCLAIM-2 confirmatory trial did not meet its primary endpoint, the company disclosed Oct. 2. The FDA gave the kinase inhibitor accelerated approval on Sept. 15, 2021, for the treatment of adults with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. The company says it made the decision in consultation with the FDA and is working with the agency on withdrawal timing. It also is working with other regulatory agencies to withdraw the drug globally. In the meantime, Takeda says it is working to make sure that people receiving Exkivity can maintain access to the medication.

Sept. 8: The FDA approved BioLineRx Ltd.’s Aphexda (motixafortide) in combination with filgrastim to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in people with multiple myeloma. The agency gave the agent orphan drug designation. Dosing for Aphexda is 1.25 mg/kg based on actual body weight via subcutaneous injection after filgrastim has been administered daily for four days and 10 to 14 hours prior to the start of apheresis. The drug’s price is $5,900 per vial, and the company has said that it expects most patients will need two vials.

Sept. 8: The FDA expanded the label of Sandoz Inc.’s Hyrimoz (adalimumab-adaz) to include the treatment of adults with non-infectious intermediate and posterior uveitis and panuveitis. The agency first approved the biosimilar of AbbVie Inc.’s TNF inhibitor Humira (adalimumab) on Oct. 30, 2018. Dosing starts with 80 mg via subcutaneous injection, followed by 40 mg every other week starting one week after the initial dose. The agent is available in a low-concentration, citrate-free version of its reference drug. The product launched in July with two wholesale acquisition costs: a branded version with a WAC of $6,576 and an unbranded one for $1,315 for a carton of two syringes or autoinjectors.

The FDA recently approved the first biosimilar for the treatment of multiple sclerosis (MS): Tyruko (natalizumab-sztn) from Novartis Pharmaceutical Corp. subsidiary Sandoz Inc. The drug is entering a fairly crowded class, and payers have said they expect it to have a moderate impact on their management of the other agents available to treat the condition.

On Aug. 24, the FDA approved Tyruko for the treatment of two indications: (1) adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease, and (2) adults with moderately to severely active Crohn’s disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional Crohn’s therapies and tumor necrosis factor (TNF) inhibitors.

The Center for Medicare Advocacy and the Community Legal Services clinic at the University of the Pacific, McGeorge School of Law filed a class action lawsuit (Case 2:23-cv-01932-DB) against HHS on Sept. 8 on behalf of Medicare beneficiaries who have lost coverage of certain Medicare Part B drugs. Plaintiffs were receiving the Janssen Pharmaceutical Companies of Johnson & Johnson’s Stelara (ustekinumab) in an outpatient clinic, where the agent was administered by health care professionals and covered under Part B as an agent provided “incident to” a physician’s service due to disabilities that prevent them from self-administration. In October 2021, HHS denied coverage of Stelara under Part B because it had determined that the drug is “usually self-administered by the patient.” HHS did not notify patients about the change, and it did not require providers to issue a notice. One plaintiff had four injections of more than $40,000 each, while another had two injections of about $58,000 each, before they realized that they were responsible for the full cost of the drug. Plaintiffs are seeking “timely, adequate notice” be required when a Part B drug that has been furnished incident to a practitioner’s service is added to the self-administered drug (SAD) list, as well as a modification to Medicare allowing beneficiaries who cannot self-administer a medically necessary drug due to a disability to be able to receive Medicare-covered medications administered by a health care professional, among other requests.

Aug. 9: The FDA gave accelerated approval to the Janssen Pharmaceutical Companies of Johnson & Johnson’s Talvey (talquetamab-tgvs) for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. The review was conducted under Project Orbis in collaboration with the Australian Therapeutic Goods Administration and Switzerland’s Swissmedic; it used the Assessment Aid. The agent, a G protein-coupled receptor class C group 5 member D (GPRC5D)-directed CD3 T-cell engager, is a first-in-class bispecific antibody. Dosing of the subcutaneous injection, which is administered by a qualified health care professional, can be done weekly or biweekly. For weekly dosing, a step-up schedule consists of 0.01 mg/kg on day one, then 0.06 mg/kg on day four, then 0.4 mg/kg on day seven and then 0.4 mg/kg one week later and weekly thereafter. For biweekly dosing, administration starts at 0.01 mg/kg on day one, 0.06 mg/kg on day four, 0.4 mg/kg on day seven, then 0.8 mg/kg on day 10 and then 0.8 mg/kg two weeks later and every two weeks thereafter. The drug’s list price is $45,000 per month, and the company estimates a pricing range of $270,000 to $360,000 for an average treatment duration of six to eight months.

The FDA recently granted another approval to Taiho Pharmaceutical Co., Ltd. division Taiho Oncology, Inc.’s Lonsurf (trifluridine/tipiracil) for a type of colorectal cancer. The decision provides another treatment option for a condition that respondents to a Zitter Insights survey regard as in need of more effective therapies.

On Aug. 2, the FDA approved Lonsurf as a single agent or in combination with bevacizumab for the treatment of adults with metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) drug and, if Rat sarcoma (RAS) wild-type, an anti-epidermal growth factor receptor (EGFR) therapy. The agency first approved the oral nucleoside antitumor agent on Sept. 22, 2015. The newest use had priority review. Dosing for the tablet is 35 mg/m2 twice daily on days one through five and days eight through 12 of each 28-day cycle. Drugs.com lists the price of 20 6.14 mg/15 mg tablets as more than $4,204.

Sen. Mike Lee (R-Utah) reintroduced the Biosimilar Red Tape Elimination Act (S. 2305), his office said on July 13. The legislation is focused on increasing competition among biologics and lowering consumer costs for them. He first introduced the bill, which would do away with the FDA requirement for switching studies for biosimilars seeking the interchangeability designation, on Nov. 17, 2022. The legislation has been referred to the Senate Committee on Health, Education, Labor, and Pensions.

Clearway Health is working with The Brooklyn Hospital Center to help improve access to specialty pharmacy drugs for underserved patients, Clearway Health said on Aug. 2. The company, which partners with hospitals and health systems to build or improve their own specialty pharmacy programs, said it will help the hospital by broadening its services, decreasing patients’ financial responsibilities, improving patient adherence and boosting clinical outcomes.