Samsung Bioepis Co., Ltd. announced today that the U.S. Food and
Drug Administration (FDA) has approved the Biologics License
Application (BLA) for PYZCHIVA® (ustekinumab-ttwe) subcutaneous
injection and intravenous infusion as a biosimilar to Stelara1
(ustekinumab). PYZCHIVA has been approved for the treatment of
moderate to severe plaque psoriasis who are candidates for
phototherapy or systemic therapy, active psoriatic arthritis,
moderately to severely active Crohn’s disease, and moderately to
severely active ulcerative colitis. Additionally, a provisional
determination was granted for PYZCHIVA’s interchangeability.
“The FDA approval of PYZCHIVA as a biosimilar to
Stelara is an important milestone for patients living with
inflammatory conditions, as biosimilars can offer more choice and
access to biologic treatments,” said Byoung In Jung, Vice President
and Regulatory Affairs Team Leader at Samsung Bioepis. “In
addition, biosimilars have a potential to reduce the financial
burden of healthcare systems, especially in the US where biologics
account for more than 46% of the annual drug spending. We will
continue to reinforce our commitment to widen access to medicines
by advancing our biosimilar pipeline for the benefits of patients,
healthcare providers, and healthcare systems around the world,” she
added.
The FDA’s approval of PYZCHIVA is based on a
totality of evidence including analytical, non-clinical and
clinical data demonstrating biosimilarity to Stelara, with no
clinically meaningful differences in terms of safety, purity and
potency: The randomized, double-blind, three-arm, parallel-group,
single-dose Phase 1 clinical study (NCT04772274) demonstrated
pharmacokinetics (PK) equivalence and comparable safety,
tolerability, immunogenicity profiles between PYZCHIVA (SB17) and
Stelara in healthy volunteers. The randomized, double-blind,
multicenter Phase 3 clinical study (NCT04967508), conducted in
patients with moderate to severe plaque psoriasis, demonstrated
biosimilarity of SB17 with Stelara through equivalent efficacy and
comparable safety and PK profiles up to Week 28 and these primary
results were published in the Journal of the American Academy of
Dermatology.2 In addition, the Phase 3 study demonstrated
biosimilarity of SB17 to Stelara up to week 28 in terms of
efficacy, safety, pharmacokinetics, and immunogenicity, and these
data were presented at the 2024 American Academy of Dermatology
(AAD) Annual Meeting in March 2024.3
PYZCHIVA, developed by Samsung Bioepis, will be
commercialized by Sandoz in the United States. Samsung Bioepis and
Sandoz entered into a commercialization agreement for SB17
(PYZCHIVA) in September 2023 for the US, Canada, European Economic
Area (EEA), Switzerland, and United Kingdom (UK). In the US, the
license period for PYZCHIVA will begin on February 22, 2025,
according to the settlement and license agreement between Samsung
Bioepis and Janssen Biotech Inc.
Samsung Bioepis has a total of 11 biosimilars in
its products and pipeline portfolio across immunology, oncology,
ophthalmology, hematology, nephrology, and endocrinology. Samsung
Bioepis has seven biosimilars approved in the US and four
commercially available as of June 2024.
About
PYZCHIVA® (ustekinumab-ttwe)
injection, for subcutaneous (45 mg/0.5 mL and 90 mg/mL) or
intravenous (130 mg/26 mL solution) use
PYZCHIVA (ustekinumab-ttwe) is indicated for:
- Plaque Psoriasis:
PYZCHIVA is indicated for the treatment of adults and pediatric
patients 6 years of age and older with moderate to severe plaque
psoriasis who are candidates for phototherapy or systemic
therapy.
- Psoriatic Arthritis:
PYZCHIVA is indicated for the treatment of adults and pediatric
patients 6 years of age and older with active psoriatic
arthritis.
- Crohn’s Disease:
PYZCHIVA is indicated for the treatment of adult patients with
moderately to severely active Crohn’s disease.
- Ulcerative Colitis:
PYZCHIVA is indicated for the treatment of adult patients with
moderately to severely active ulcerative colitis.
SELECTED IMPORTANT SAFETY
INFORMATION
CONTRAINDICATIONSPYZCHIVA is
contraindicated in patients with clinically significant
hypersensitivity to ustekinumab products or to any of the
excipients in PYZCHIVA.
WARNINGS AND PRECAUTIONS
InfectionsUstekinumab products may
increase the risk of infections and reactivation of latent
infections. Serious bacterial, mycobacterial, fungal, and viral
infections were observed in patients receiving ustekinumab
products.
Serious infections requiring hospitalization, or
otherwise clinically significant infections, reported in clinical
studies included the following:
- Plaque Psoriasis: diverticulitis,
cellulitis, pneumonia, appendicitis, cholecystitis, sepsis,
osteomyelitis, viral infections, gastroenteritis and urinary tract
infections.
- Psoriatic arthritis:
cholecystitis.
- Crohn’s disease: anal abscess,
gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeria
meningitis.
- Ulcerative colitis: gastroenteritis,
ophthalmic herpes zoster, pneumonia, and listeriosis.
Avoid initiating treatment with PYZCHIVA in
patients with any clinically important active infection until the
infection resolves or is adequately treated. Consider the risks and
benefits of treatment prior to initiating use of PYZCHIVA in
patients with a chronic infection or a history of recurrent
infection.
Instruct patients to seek medical advice if signs
or symptoms suggestive of an infection occur while on treatment
with PYZCHIVA and discontinue PYZCHIVA for serious or clinically
significant infections until the infection resolves or is
adequately treated.
Theoretical Risk for Vulnerability to
Particular InfectionsIndividuals genetically deficient in
IL-12/IL-23 are particularly vulnerable to disseminated infections
from mycobacteria (including nontuberculous, environmental
mycobacteria), salmonella (including nontyphi strains), and
Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and
fatal outcomes have been reported in such patients.
It is not known whether patients with pharmacologic
blockade of IL-12/IL-23 from treatment with ustekinumab products
may be susceptible to these types of infections. Consider
appropriate diagnostic testing (e.g., tissue culture, stool
culture, as dictated by clinical circumstances).
Pre-treatment Evaluation for
TuberculosisEvaluate patients for tuberculosis infection
prior to initiating treatment with PYZCHIVA.
Avoid administering PYZCHIVA to patients with
active tuberculosis infection. Initiate treatment of latent
tuberculosis prior to administering PYZCHIVA. Consider
anti-tuberculosis therapy prior to initiation of PYZCHIVA in
patients with a past history of latent or active tuberculosis in
whom an adequate course of treatment cannot be confirmed. Closely
monitor patients receiving PYZCHIVA for signs and symptoms of
active tuberculosis during and after treatment.
MalignanciesUstekinumab products
are immunosuppressants and may increase the risk of malignancy.
Malignancies were reported among subjects who received ustekinumab
in clinical studies. In rodent models, inhibition of IL-12/IL-23p40
increased the risk of malignancy.
The safety of ustekinumab products has not been
evaluated in patients who have a history of malignancy or who have
a known malignancy.
There have been post-marketing reports of the rapid
appearance of multiple cutaneous squamous cell carcinomas in
patients receiving ustekinumab products who had pre-existing risk
factors for developing non-melanoma skin cancer. Monitor all
patients receiving PYZCHIVA for the appearance of non-melanoma skin
cancer. Closely follow patients greater than 60 years of age, those
with a medical history of prolonged immunosuppressant therapy and
those with a history of PUVA treatment
Hypersensitivity
ReactionsHypersensitivity reactions, including anaphylaxis
and angioedema, have been reported with ustekinumab products. If an
anaphylactic or other clinically significant hypersensitivity
reaction occurs, institute appropriate therapy and discontinue
PYZCHIVA.
Posterior Reversible Encephalopathy
Syndrome (PRES)Two cases of posterior reversible
encephalopathy syndrome (PRES), also known as Reversible Posterior
Leukoencephalopathy Syndrome (RPLS), were reported in clinical
trials. Cases have also been reported in postmarketing experience
in patients with psoriasis, psoriatic arthritis and Crohn’s
disease. Clinical presentation included headaches, seizures,
confusion, visual disturbances, and imaging changes consistent with
PRES a few days to several months after ustekinumab product
initiation. A few cases reported latency of a year or longer.
Patients recovered with supportive care following withdrawal of
ustekinumab products.
Monitor all patients treated with PYZCHIVA for
signs and symptoms of PRES. If PRES is suspected, promptly
administer appropriate treatment and discontinue PYZCHIVA.
ImmunizationsPrior to initiating
therapy with PYZCHIVA, patients should receive all age-appropriate
immunizations as recommended by current immunization guidelines.
Patients being treated with PYZCHIVA should avoid receiving live
vaccines. Avoid administering BCG vaccines during treatment with
PYZCHIVA or for one year prior to initiating treatment or one year
following discontinuation of treatment. Caution is advised when
administering live vaccines to household contacts of patients
receiving PYZCHIVA because of the potential risk for shedding from
the household contact and transmission to patient.
Non-live vaccinations received during a course of
PYZCHIVA may not elicit an immune response sufficient to prevent
disease.
Noninfectious PneumoniaCases of
interstitial pneumonia, eosinophilic pneumonia and cryptogenic
organizing pneumonia have been reported during post-approval use of
ustekinumab products. Clinical presentations included cough,
dyspnea, and interstitial infiltrates following one to three doses.
Serious outcomes have included respiratory failure and prolonged
hospitalization. Patients improved with discontinuation of therapy
and in certain cases administration of corticosteroids. If
diagnosis is confirmed, discontinue PYZCHIVA and institute
appropriate treatment.
Most common adverse reactions
are:
- Psoriasis (≥3%): nasopharyngitis,
upper respiratory tract infection, headache, and fatigue.
- Crohn’s Disease, induction (≥3%):
vomiting.
- Crohn’s Disease, maintenance (≥3%):
nasopharyngitis, injection site erythema, vulvovaginal
candidiasis/mycotic infection, bronchitis, pruritus, urinary tract
infection, and sinusitis.
- Ulcerative colitis, induction (≥3%):
nasopharyngitis
- Ulcerative colitis, maintenance (≥3%):
nasopharyngitis, headache, abdominal pain, influenza, fever,
diarrhea, sinusitis, fatigue, and nausea
Please see Full Prescribing Information for
PYZCHIVA™ (ustekinumab-ttwe)
HERE, which includes the
Boxed Warning, 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, nephrology, and endocrinology.
For more information, please visit: www.samsungbioepis.com and
follow us on social media – X, LinkedIn.
Media ContactYoon Kim,
yoon1.kim@samsung.comAnna Nayun Kim, nayun86.kim@samsung.com
____________________________
1 Stelara is a trademark of Johnson &
Johnson.
2 Steven R. Feldman, et al. A randomized,
double-blind, phase III study assessing clinical similarity of SB17
(proposed ustekinumab biosimilar) to reference ustekinumab in
subjects with moderate-to-severe plaque psoriasis. Journal of the
American Academy of Dermatology. 2024. ISSN 0190-9622.
https://doi.org/10.1016/j.jaad.2024.04.045.
3 Samsung Bioepis News Release. Samsung Bioepis
Presents Two Abstracts for Its Immunology Portfolio at the 2024
American Academy of Dermatology (AAD) Annual Meeting. March 9,
2024.
https://www.globenewswire.com/news-release/2024/03/09/2843392/0/en/Samsung-Bioepis-Presents-Two-Abstracts-for-Its-Immunology-Portfolio-at-the-2024-American-Academy-of-Dermatology-AAD-Annual-Meeting.html.
Accessed June 2024