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Generic medicines play a pivotal role in offering cost-effective alternatives to high-priced pharmaceuticals. They often serve as a critical lifeline in developing and underdeveloped nations, helping to address both chronic and infectious diseases.
In 2024, the global generics market was valued at $445.62B, with projections to reach approximately $468.08B in 2025 and ~$728.64B by…
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Hikma Pharmaceuticals & Celltrion have entered into exclusive licensing agreements for various biosimilar candidates across the Middle East & North Africa (MENA) region, expanding their previous partnerships
The agreement will include the commercialization of 6 biosimilars to expand access across multiple therapeutic areas, incl. allergic diseases, ophthalmology, skeletal-related disorders, immune diseases & oncology
As…
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Celltrion has launched Avtozma IV, a biosimilar to Actemra (tocilizumab) for all the approved indications of the reference product in the US
In Jan 2025, the FDA approved Avtozma based on a global P-III trial showing comparable efficacy, PK, safety & immunogenicity vs reference tocilizumab, followed by an additional July 2025 FDA approval for…
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Health Canada has approved Stoboclo & Osenvelt (CT-P41), referencing biosimilar Prolia & Xgeva, for all approved indications of the reference drugs
Approval was supported by P-III trial data in postmenopausal women with osteoporosis (PMO), showing CT-P41 matched reference denosumab in efficacy & PD, with similar PK, safety, and immunogenicity
Stoboclo and Osenvelt are RANKL…
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The US FDA has approved Avtozma IV, a biosimilar to Actemra (tocilizumab), for treating cytokine release syndrome in pts (≥2yrs.), covering all Actemra IV-approved indications in the US; expected to be available in the US by Aug 31, 2025
In Jan 2025, the US FDA approved Avtozma IV to treat rheumatoid arthritis (RA), giant…
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Unlike hematologic malignancies, where the elimination of most or all tumor cells results in immunosuppression, making headways in solid tumors requires a new holistic approach when using T Cell Engagers
Abpro’s ABP-102/CT-P72, co-developed by Celltrion leverages a tetravalent format; bivalent for both HER2 and CD3
PharmaShots welcomes Shaun Murphy, Vice President, Nonclinical Research and…
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Celltrion has launched Osenvelt & Stoboclo, biosimilar versions of Amgen’s Xgeva & Prolia (denosumab) in the US
Stoboclo (60mg/mL) treats postmenopausal women & men with osteoporosis at high fracture risk, glucocorticoid-induced osteoporosis in both sexes, & increases bone mass in men on androgen deprivation therapy for nonmetastatic prostate cancer & women on adjuvant aromatase inhibitors…
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The US FDA has approved Steqeyma (45mg/0.5mL, SC, single-dose vial), a biosimilar version of Stelara (ustekinumab) for the treatment of pts (6-17yrs.; ≤60kg) with plaque PsO or PsA
Approval was supported by extensive clinical data, incl. P-III trial of Steqeyma vs Stelara for mod. to sev. plaque PsO, with 1EP as rate of change…
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FDA has granted interchangeability designation to Yuflyma, a biosimilar version of Humira (adalimumab) for prefilled syringe (40mg) & autoinjectors (40 & 80mg) expanding on the prior designation for the 20mg & 80mg prefilled syringes
Designation was based on P-III interchangeability trial showing comparable PK, efficacy, safety, & immunogenicity in pts with mod. to sev.…
Shots:
The US FDA has granted interchangeability designation to Yuflyma, a biosimilar version of Humira (adalimumab)
Designation was backed by P-III interchangeability trial showing comparable PK, efficacy, safety, & immunogenicity in pts with mod. to sev. PsO receiving reference adalimumab (ADA) continuously or those who alternated between ADA & Yuflyma during Wk. 25-27; data was…

