Skip to content Skip to footer
Subscribe Now
INSIGHTS+

Key Biosimilars Events of December 2025  

Shots:        Regulatory and launch momentum accelerated globally in late 2025, with multiple FDA approvals, CHMP positive opinions, and EU/US launches for biosimilars referencing blockbuster biologics such as Prolia/Xgeva, Lucentis, Eylea, Xolair, Stelara, Simponi, Neulasta, Humira, Opdivo, and Keytruda—broadening patient access across oncology, immunology, ophthalmology, bone health, and allergy indications  Leading biosimilar developers including Samsung Bioepis, Celltrion, Alvotech, Formycon,…
5 days ago

Read more

Samsung Bioepis
NEWS

Samsung Bioepis Began Direct Commercialization of Byooviz (Biosimilar, Lucentis) Across Europe

Shots: Samsung Bioepis has reported the direct commercialization of Byooviz, a biosimilar version of Lucentis (ranibizumab) across Europe, with market availability expected in Q2’26 Byooviz (0.5 mg/0.05 ml) is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due…
January 2, 2026

Read more

Samsung Bioepis
NEWS

Samsung Bioepis’ Ustekinumab BS (Biosimilar, Stelara) Approved in Japan 

Shots:  Samsung Bioepis has received Japanese marketing approval for Ustekinumab BS 45mg syringes, a biosimilar of Stelara, under its partnership with NIPRO Corporation  Ustekinumab, a human IgG1κ antibody targeting IL-12/IL-23, is approved in Japan as ‘NIPRO’ for plaque psoriasis and psoriatic arthritis, with NHI listing expected in May 2026   It is also approved in Australia, Brazil, Canada,…
December 23, 2025

Read more

Samsung Bioepis
NEWS

Samsung Bioepis Receive the CHMP Positive Opinion for Byooviz (Biosimilar, Lucentis) 

Shots:  The CHMP has recommended Samsung Bioepis’ Byooviz  (0.5 mg/0.05 ml PFS), a biosimilar version of Lucentis (ranibizumab). The PFS presentation is expected to launch in Q2’26  Byooviz is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), and…
December 2, 2025

Read more

Samsung Bioepis
NEWS

Samsung Bioepis Reports EU Launch of Obodence & Xbryk (Biosimilar, Prolia & Xgeva)

Shots: Samsung Bioepis has launched Obodence (60mg PFS) & Xbryk (120mg vial), biosimilar versions of Prolia & Xgeva, for bone health treatments, with commercial availability expected by Dec 2025 & Jan 2026, respectively Obodence treats postmenopausal women & men with osteoporosis at high fracture risk, glucocorticoid-induced osteoporosis in both sexes, & bone loss in men on…
December 1, 2025

Read more

NEWS

Samsung Bioepis & Johnson & Johnson have Entered into an Agreement for the Commercialization of Pyzchiva (Biosimilar, Stelara) Across EU 

Shots:  Samsung Bioepis has signed a confidential settlement and license agreement with Johnson & Johnson for the commercialization of Pyzchiva, its Stelara (ustekinumab) biosimilar in Europe  Ustekinumab is an IgG1κ monoclonal antibody targeting IL-12 and IL-23. PYZCHIVA, developed by Samsung Bioepis, received European Commission approval as a Stelara biosimilar in April 2024  PYZCHIVA was introduced in the EU by Sandoz in July…
November 6, 2025

Read more

NEWS

Samsung Bioepis Enters Asset Purchase Deal with Biogen for Byooviz (Biosimilar, Lucentis) and Opuviz (Biosimilar, Eylea) in the EU

Shots: Samsung Bioepis has entered an asset purchase agreement with Biogen to acquire its ophthalmology assets, Byooviz & Opuviz, biosimilar versions of Lucentis (ranibizumab) & Eylea (aflibercept), in the EU Samsung Bioepis will assume full responsibility for the commercialization of Byooviz following the transfer of rights from Biogen, effective January 2026 Byooviz was approved by…
October 29, 2025

Read more

INSIGHTS+

Key Biosimilars Events of July 2025  

Shots:        Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency         Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients         Samsung Bioepis Collaborates with Harrow to Commercialize its Ophthalmology Biosimilars in the…
August 5, 2025

Read more

NEWS

Samsung Bioepis Collaborates with Harrow to Commercialize its Ophthalmology Biosimilars in the US

Shots: Samsung Bioepis has entered into a definitive agreement to grant Harrow exclusive commercial rights of its ophthalmology biosimilar portfolio incl. Byooviz, biosimilar to Lucentis (ranibizumab), & Opuviz, biosimilar to Eylea (aflibercept) in the US Byooviz has been available in the US through Biogen since its launch in Jun 2022. In Oct 2024, Biogen notified…
July 18, 2025

Read more

Samsung Bioepis ans NIPRO
NEWS

Samsung Bioepis Collaborates with NIPRO to Commercialize Biosimilar Candidates in Japan 

Shots: Samsung Bioepis & NIPRO have entered into a license, development & commercialization agreement for various biosimilar candidates, incl. SB17, a biosimilar version of Stelara (ustekinumab) in Japan As per the deal, NIPRO will be responsible for commercialization of the biosimilar candidates in Japan, with Samsung Bioepis handling development, manufacturing & supply activities Ustekinumab is…
June 9, 2025

Read more

Load more