Biosimilars

Would Proposed Changes on Interchangeability Diminish Designation?

By Angela Maas

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.

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Newly Approved Tofidence, First Actemra Biosimilar, Expected to Have Some Impact for Payers, Rheumatologists

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.

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News Briefs: Hawaii Sues Big PBMs

The state of Hawaii on Oct. 4 in federal court sued the Big Three PBMs — CVS Health Corp.’s Caremark, UnitedHealth Group’s Optum Rx, and The Cigna Group’s Express Scripts. The suit accuses the firms of “siphon[ing] increasing amounts of money from the pharmaceutical supply chain while significantly increasing prices for consumers, employers, and other health care payers” through unfair trade practices. According to a press release from Hawaii Gov. Josh Green, M.D., and Attorney General Anne Lopez, both Democrats, the complaint accuses PBMs of “unfair methods of competition and unfair and deceptive acts and practices in violation of Hawaiʻi law,” such as inappropriate fees charged to manufacturers for formulary placement. The state will seek civil penalties of $10,000 per violation, with additional penalties sought for “each deceptive or unfair act that was directed towards an elder.”

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Sandoz’s Tyruko, First Multiple Sclerosis Biosimilar, Gains FDA Approval

The first biosimilar for the treatment of multiple sclerosis recently received FDA approval, and when it launches, Tyruko (natalizumab-sztn) from Polypharma Biologics and Sandoz Inc. will enter a competitive therapeutic class that is a high priority for management. Payers have said they expect the new treatment 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.

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News Briefs: Boehringer Ingelheim Launched Unbranded Interchangeable Humira Biosimilar

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.

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AscellaHealth Assesses New, Anticipated Specialty Treatments

The specialty drug landscape continues to be a dynamic space, as new agents enter the market and existing ones gain FDA approval for additional indications. Global health care and specialty pharmacy solutions organization AscellaHealth recently released its quarterly breakdown of insights into treatments within the segment.

The Q3 2023 Specialty & Rare Pipeline Digest examines new approvals and launches of specialty drugs, including biosimilars, generics, and cell and gene therapies, as well as ones in the pipeline.

Among the highlighted agents in the recently released report were Alzheimer’s disease drug Leqembi (lecanemab-irmb) from Eisai Inc. and Biogen, myasthenia gravis therapy Rystiggo (rozanolixizumab-noli) from UCB, Inc. and Pfizer Inc.’s alopecia areata medication Litfulo (ritlecitinib).

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New FDA Approvals: FDA Approves BioLineRx’s Aphexda

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.

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CVS Steps Into Biosimilar Space With New Subsidiary Cordavis

CVS Health is getting into the biosimilars business, the company said in late August, and will officially enter the market on Jan. 1 in partnership with a Humira biosimilar. CVS stressed the importance of driving use of biosimilars and ensuring their supply, which sources say is a positive development. But one industry source questions whether the new company raises potential conflict-of-interest issues.

On Aug. 23, CVS revealed that it had launched the wholly owned subsidiary Cordavis to commercialize and/or co-produce biosimilars in collaboration with drug manufacturers. “Through Cordavis, CVS Health intends to develop a portfolio of products that it expects will facilitate broader access to biosimilars in the U.S. — creating more competition that drives down prices — while encouraging investment in future products,” said the company in a press release.

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FDA Approves First Multiple Sclerosis Biosimilar, Sandoz’s Tyruko

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.

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Now That Humira Biosimilars Have Launched, What Are Lessons Learned for Stelara Biosimilars?

Following the launch of almost 10 biosimilars of AbbVie Inc.’s Humira (adalimumab) this year, 2025 will be another big year for the U.S. biosimilar market, when no less than three versions of Stelara (ustekinumab) from the Janssen Pharmaceutical Companies of Johnson & Johnson are set to become available. Having the experience of assessing multiple competitors with varying attributes could help payers as they prepare for the launches, say industry experts.

Stelara is a human interleukin-12 (IL-12) and -23 (IL-23) antagonist indicated for the treatment of adults with moderately to severely active Crohn’s disease, adults with moderately to severely active ulcerative colitis, 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 years old with active psoriatic arthritis.

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