INCHEON, Korea, March 09, 2024 (GLOBE NEWSWIRE) — Samsung Bioepis Co., Ltd. presented two new study results for its immunology portfolio – SB5, a biosimilar to Humira1 (adalimumab), and SB17, a proposed biosimilar to Stelara2 (ustekinumab) – at the 2024 American Academy of Dermatology (AAD) Annual Meeting being held from March 8 to 12 in San Diego, California, United States.
“We are excited to present new clinical data for our immunology portfolio at AAD Annual Meeting. We will continue to work towards generating robust scientific evidence that demonstrate comparable efficacy and safety of biosimilars to reference products, including data for switching from reference products to biosimilars,” said Ilsun Hong, Vice President, Production Evaluation Team Leader of Samsung Bioepis.
SB5, approved by the U.S. Food and Drug Administration (FDA) under the brand name HADLIMA™ (adalimumab-bwwd) as a biosimilar to Humira, is being reviewed by the FDA as an interchangeable biosimilar to Humira based on the Phase 4 study results. The Phase 4 randomized, double-blind, parallel-group, multiple-dose, active comparator, multicenter study (NCT05510063) assessed pharmacokinetics (PK), efficacy, safety, and immunogenicity in two treatment groups of adult patients with moderate to severe plaque psoriasis: patients who switched between reference product Humira and the high-concentration formulation SB5 (40 mg/0.4 mL) versus those receiving reference product continuously. The interchangeability study met primary endpoints of AUCtau (week 23-25) and Cmax (week 23-25), demonstrating comparability between the switching group and continuous reference product treatment group. Other endpoints including efficacy, safety, and immunogenicity were also comparable.
SB5 was first approved by the FDA in July 2019 under the brand name HADLIMA (adalimumab-bwwd) as a low-concentration (40 mg/0.8 mL) formulation of prefilled syringe and prefilled autoinjector. The high-concentration (40 mg/0.4 mL) formulation of prefilled syringe and prefilled autoinjector of HADLIMA was approved in August 2022. HADLIMA was introduced into the U.S. commercial market on July 1, 2023 and is marketed by Organon.
In addition, Samsung Bioepis presented the final 52-week results from the Phase 3 study for SB17, comparing the long-term efficacy, safety, and immunogenicity between three treatment groups: SB17-treated group, reference ustekinumab-treated group, and switched group from reference ustekinumab to SB17 at Week 28. The study showed that efficacy, safety, and immunogenicity between the three arms were comparable up to Week 52.
SB17 was recommended for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in February 2024 under the brand name PYZCHIVA™. In the United States, the Biologics License Application (BLA) for SB17 is under review by the FDA. If approved, SB17 will be commercialized by Sandoz in Europe and the U.S.
Details of the Samsung Bioepis’ abstracts are as follows:
Presentation Title | Presentation Details |
Interchangeability of SB5 and Adalimumab Reference Product in Patients with Moderate to Severe Chronic Plaque Psoriasis | Session: Poster Exhibit Date/Time: March 8-9th, 2024, 8:30 AM – 5:00 PM Abstract Number: 50522 Authors: Steven R. Feldman, Skaidra Valiukevičienė, Grazyna Pulka, Elzbieta Krolikowska, Pawel Brzewski, Malgorzata Janczylo-Jankowska, Bartlomiej Kwiek, Lidia Rajzer, Soyeon Kim, Yumin Baek, Hyuna Lee |
Clinical Similarity of SB17 (Proposed Ustekinumab Biosimilar) to Reference Ustekinumab in Patients with Moderate to Severe Plaque Psoriasis: Randomized, Double-blind, Phase III, 52-Week Results | Session: Poster Exhibit Date/Time: March 8-9th, 2024, 8:30 AM – 5:00 PM Abstract Number: 49140 Authors: Steven R. Feldman, Joanna Narbutt, Giampiero Girolomoni, Jan Brzezicki, Nataliya Reznichenko, Maria Agnieszka Zegadlo-Mylik, Grazyna Pulka, Magdalena Dmowska-Stecewicz, Jiyoon Lee, Minkyung Lee, Young Hee Rho |
About HADLIMA (adalimumab-bwwd) Injection 40 mg/0.4 mL and 40 mg/0.8mL
HADLIMA is a tumor necrosis factor (TNF) blocker indicated for:
Limitations of Use:
The effectiveness of HADLIMA has not been established in patients who have lost response to or were intolerant to tumor necrosis factor (TNF) blockers.
SELECTED SAFETY INFORMATION
SERIOUS INFECTIONS
Patients treated with adalimumab products, including HADLIMA, are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Discontinue HADLIMA if a patient develops a serious infection or sepsis.
Reported infections include:
Carefully consider the risks and benefits of treatment with HADLIMA prior to initiating therapy in patients:
Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HADLIMA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
MALIGNANCY
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab products. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.
HYPERSENSITIVITY
Anaphylaxis and angioneurotic edema have been reported following adalimumab administration. If a serious allergic reaction occurs, stop HADLIMA and institute appropriate therapy.
HEPATITIS B VIRUS REACTIVATION
Use of TNF blockers, including HADLIMA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal.
Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.
Exercise caution in patients who are carriers of HBV and monitor them during and after HADLIMA treatment.
Discontinue HADLIMA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming HADLIMA after HBV treatment.
NEUROLOGIC REACTIONS
TNF blockers, including adalimumab products, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome.
Exercise caution when considering HADLIMA for patients with these disorders; discontinuation of HADLIMA should be considered if any of these disorders develop.
HEMATOLOGIC REACTIONS
Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with adalimumab products.
Consider stopping HADLIMA if significant hematologic abnormalities occur.
CONGESTIVE HEART FAILURE
Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have been observed with adalimumab products; exercise caution and monitor carefully.
AUTOIMMUNITY
Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.
IMMUNIZATIONS
Patients on HADLIMA should not receive live vaccines.
Pediatric patients, if possible, should be brought up to date with all immunizations before initiating HADLIMA therapy.
Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero-exposed infant. The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab products in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.
ADVERSE REACTIONS
The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (eg, upper respiratory, sinusitis), injection site reactions, headache, and rash.
Before prescribing HADLIMA, please read the accompanying Full Prescribing Information, including the Boxed Warning about serious infections and malignancies, Medication Guide and Instructions for Use.
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – X, LinkedIn.
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1 Humira is a trademark registered in the US by AbbVie Biotechnology Ltd.
2 Stelara is a trademark of Johnson & Johnson.
CONTACT: MEDIA CONTACT Anna Nayun Kim, nayun86.kim@samsung.com Jane Chung, ejane.chung@samsung.com
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