Celltrion Receives EC Approval for Remsima IV (Biosimilar, Remicade)

Shots: The EC has approved Remsima IV (100mg and 350mg vials), a liquid formulation, a biosimilar version of Remicade The approval is supported by data showing the liquid and powder infliximab formulations are comparable in CMC characteristics and stability after reconstitution and dilution The Remsima IV liquid formulation is EU-approved for all existing IV infliximab indications, including RA, adult and pediatric CD and UC,…

ByDipanshu DixitNovember 18, 2025

NEWS

The EC Approves Additional Presentation of Celltrion’s Omlyclo (Biosimilar, Xolair)

Shots: The EC has approved Omlyclo, a biosimilar version of Xolair (omalizumab), in PFS presentation (300 mg/2ml) for the treatment of pts with allergic asthma, chronic spontaneous urticaria (CSU) & chronic rhinosinusitis with nasal polyps (CRSwNP) Omlyclo previously received the EC approval in May 2024 for PFS injections at 75mg/0.5mL & 150mg/1mL Omalizumab is a…

ByRidhi RastogiNovember 18, 2025

NEWS

Kaigene Inks ~$744M Licensing Deal with Celltrion for KG006 and KG002 to Treat Autoimmune Diseases

Shots: Kaigene has granted Celltrion exclusive global rights to develop & commercialize KG006 (excl. Greater China & Japan) & KG002 As per the deal, Kaigene will receive $8M upfront, & ~$736M in milestone payments, incl. $11M in near-term milestones through the initiation of P-I trials, along with net sales-based tiered royalties KG006 is an FcRn…

ByRidhi RastogiNovember 4, 2025

NEWS

The FDA Grants Interchangeability Designation to Celltrion’s Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva)

Shots: The US FDA has granted interchangeable designation to Stoboclo & Osenvelt, biosimilar versions of Prolia & Xgeva (denosumab), respectively, for all approved indications of the reference product Designation was based on extensive data, incl. analytical data demonstrating similarity of Stoboclo & Osenvelt with reference product & P-III trial results in postmenopausal women with osteoporosis, which showed comparable…

ByRidhi RastogiOctober 30, 2025

NEWS

FDA Approves Celltrion’s Yuflyma (Biosimilar, Humira) and its Unbranded Version for Hidradenitis Suppurativa (HS) and Uveitis in Younger Patients

Shots: The US FDA has approved Yuflyma, a biosimilar version of Humira (adalimumab) & its unbranded version for the treatment of HS in adolescents (≥12yrs.), & uveitis in children (≥2yrs.) Yuflyma, an anti-TNFα mAb, was previously approved by the FDA for rheumatoid & psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, &…

ByRidhi RastogiOctober 17, 2025

NEWS

Celltrion’s Eydenzelt (Biosimilar, Eylea) Receives the US FDA’s Approval to Treat Multiple Retinal Diseases

Shots: The US FDA has approved Eydenzelt, a biosimilar version of Eylea (aflibercept), to treat neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema (DME), & diabetic retinopathy Approval was supported by extensive analytical, non-clinical, & clinical data, incl. a P-III trial in DME pts (n=348) comparing Eydenzelt vs Eylea over…

ByRidhi RastogiOctober 10, 2025

TOP 20

Top 20 Generic Pharma Companies of 2025

Shots: 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…

ByPrince GiriOctober 8, 2025

NEWS

Hikma and Celltrion Partner to Commercialize Biosimilars Across the MENA Region

Shots: 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…

ByRidhi RastogiOctober 8, 2025

NEWS

Celltrion Introduces Avtozma IV (Biosimilar, Actemra) in the US

Shots: 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…

ByRidhi RastogiOctober 6, 2025

NEWS

Celltrion Receives the Health Canada’s Approval for Stoboclo and Osenvelt (Biosimilar, Prolia & Xgeva)

Shots: 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…

ByDipanshu DixitSeptember 19, 2025

Celltrion Receives EC Approval for Remsima IV (Biosimilar, Remicade)

The EC Approves Additional Presentation of Celltrion’s Omlyclo (Biosimilar, Xolair)

Kaigene Inks ~$744M Licensing Deal with Celltrion for KG006 and KG002 to Treat Autoimmune Diseases

The FDA Grants Interchangeability Designation to Celltrion’s Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva)

FDA Approves Celltrion’s Yuflyma (Biosimilar, Humira) and its Unbranded Version for Hidradenitis Suppurativa (HS) and Uveitis in Younger Patients

Top 20 Generic Pharma Companies of 2025

Celltrion Introduces Avtozma IV (Biosimilar, Actemra) in the US

Celltrion Receives the Health Canada’s Approval for Stoboclo and Osenvelt (Biosimilar, Prolia & Xgeva)

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