Skip to content Skip to footer
Subscribe Now
NEWS

Polpharma Biologics and Libbs Farmacêutica Enter into a Licensing Agreement for an Autoimmune Biosimilar 

 Shots:  Polpharma Biologics has signed a licensing agreement with Brazil-based Libbs Farmacêutica for an autoimmune biosimilar  Under this strategic partnership, Polpharma Biologics is fully responsible for the development and manufacturing of the product  Libbs will exclusively handle the product’s commercialization, marketing, and distribution in the Brazilian market  Ref: Polpharma Biologics | Image: Polpharma Biologics | Press Release Related News:- Polpharma Biologics Launches…
December 10, 2025

Read more

NEWS

Formycon Partners with Zydus to Commercialize FYB206 (Biosimilar, Keytruda) in the US and Canada

Shots: Formycon has entered into an exclusive licensing & supply agreement with Zydus Lifesciences Global FZE, UAE (Zydus' subsidiary) to commercialize Formycon’s FYB206, a biosimilar version of Merck’s Keytruda (pembrolizumab), in the US & Canada As per the deal, Formycon will be responsible for development, registration, manufacturing & supply of the product, while Zydus Lifesciences…
December 10, 2025

Read more

NEWS

Formycon Partners with MS Pharma to Commercialize FYB206 (Biosimilar, Keytruda) in the MENA Region

Shots: Formycon has entered into an exclusive licensing & supply agreement with MS Pharma for the commercialization of Formycon’s FYB206, a biosimilar version of Merck’s Keytruda (pembrolizumab), in the MENA region As per the deal, Formycon will receive an upfront payment, potential development & regulatory milestones, & a significant share of regional gross profits, though…
December 4, 2025

Read more

Celltrion
NEWS

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

Shots: The US FDA has approved Omlyclo, an interchangeable biosimilar version of Xolair (omalizumab), in PFS presentation (300mg/2ml, SC) for the treatment of pts with allergic asthma, chronic spontaneous urticaria (CSU), chronic rhinosinusitis with nasal polyps (CRSwNP), & IgE-mediated food allergy Omlyclo previously received the US FDA approval in Mar 2025 for PFS injections at…
December 3, 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

The US FDA Approves Lupin’s Armlupeg (Biosimilar, Neulasta) 

Shots:  The US FDA has approved Armlupeg (pegfilgrastim-unne) as a biosimilar version of Neulasta (pegfilgrastim)   Armlupeg (6 mg/0.6 mL) is administered as a single-dose SC injection. It is indicated to reduce the incidence of febrile neutropenia in pts with non-myeloid cancers undergoing myelosuppressive CT and to improve survival following acute myelosuppressive radiation exposure   Armlupeg will be produced at Lupin’s Biotech facility…
December 1, 2025

Read more

Celltrion
NEWS

Celltrion’s Eydenzelt (Biosimilar, Eylea) Receives Health Canada Approval to Treat Multiple Retinal Diseases

Shots: Health Canada has approved Eydenzelt, a biosimilar version of Eylea (aflibercept 2mg), in both vial & PFS presentation for all the indications of the reference product Approval was based on extensive analytical, nonclinical, & clinical data, incl. a global 52wk. P-III trial of Eydenzelt vs Eylea in 348 pts with diabetic macular edema, which met…
November 28, 2025

Read more

NEWS

Prestige Biopharma Collaborates with Biosidus to Commercialize Tuznue (Biosimilar, Herceptin) Across LATAM

Shots: Prestige Biopharma has entered into an exclusive license & supply agreement with Biosidus to commercialize Tuznue, a biosimilar version of Herceptin (trastuzumab) across Latin American markets, incl. Argentina, Mexico, Bolivia, & Paraguay As per the deal, Biosidus gains exclusive rights to market & distribute Tuznue in Argentina, Mexico, Bolivia & Paraguay, while Prestige Biopharma…
November 26, 2025

Read more

Load more