Takeda Reports Topline P-III (LATITUDE) Trials Findings on Zasocitinib in Plaque Psoriasis (PsO)

Shots: Takeda has reported data from 2 global P-III trials (NCT06088043 & NCT06108544) assessing zasocitinib (TAK-279) vs apremilast & PBO in 693 & 1108 adult pts, respectively, with mod. to sev. PsO Trial showed superiority to PBO on co-1EPs (sPGA 0/1 & PASI 75) at Wk. 16, with early PASI 75 responses from Wk. 4, sustained…

ByRidhi RastogiDecember 18, 2025

NEWS

Celltrion’s Steqeyma (Biosimilar, Stelara) Receives the CHMP Positive Opinion for Multiple Immune-Mediated Diseases

Shots: The CHMP has recommended Celltrion's Steqeyma autoinjector (45mg/0.5mL & 90mg/1mL), a biosimilar version of Stelara (ustekinumab), for the treatment of pts with plaque psoriasis, psoriatic arthritis (PsA) & Crohn’s disease (CD) SteQeyma (CT-P43) is a human anti-IL-12 & IL-23 monoclonal antibody that is also available in SC formulation (45mg/0.5 mL or 90mg/1 mL in…

ByRidhi RastogiDecember 18, 2025

NEWS

Sandoz Launches Tyruko (Biosimilar, Tysabri) in the US

Shots: Sandoz has launched Tyruko, a biosimilar version of Biogen’s Tysabri (natalizumab), for all indications of the reference product, incl. relapsing forms of multiple sclerosis (MS) & mod. to sev. active Crohn’s disease in adults In 2019, Sandoz signed a global commercialization deal with Polpharma for Tyruko, with Polpharma responsible for development & manufacturing of…

ByRidhi RastogiNovember 17, 2025

NEWS

J&J Reports Long-Term Extension Results from GALAXI-2, GALAXI-3, and GRAVITI Trials of Tremfya (Guselkumab) for Crohn’s Disease

Shots: J&J has reported 96wk. P-III trial data in mod. to sev. Crohn’s Disease incl. GRAVITI (SC induction: 400mg Q4W; maintenance: 200mg at Wk. 12 then Q4W or 100mg at Wk. 16 then Q8W) vs PBO, & GALAXI 2 & 3 (IV induction: 200mg Q4W; SC maintenance) vs Stelara In GRAVITI, 92% (100mg) & 93.4%…

ByRidhi RastogiOctober 29, 2025

NEWS

Polpharma Biologics Enters into Licensing Deals with MS Pharma for Multiple Biosimilar Candidates

Shots: Polpharma has entered into licensing deals with MS Pharma to commercialize PB016 (vedolizumab), PB018 (ocrelizumab), & PB019 (guselkumab) biosimilars across the Middle East & North Africa (MENA) region As per the deal, MS Pharma will be responsible for registration, marketing, & distribution of the 3 biosimilars in MENA, while Polpharma will handle development, manufacturing,…

ByRidhi RastogiSeptember 2, 2025

NEWS

Bio-Thera Secures the EC’s Approval for Usymro (Biosimilar, Stelara)

Shots: The EC has approved Usymro (BAT2206), a biosimilar version of J&J’s Stelara (ustekinumab) for all indications of the reference product In Oct 2024, Bio-Thera & Gedeon Richter entered a licensing & commercialization deal under which Bio-Thera will develop & manufacture Usymro, while Gedeon will commercialize it post-approval & MA Holder transfer in the EU,…

ByRidhi RastogiAugust 27, 2025

NEWS

Polpharma Biologics Collaborates with Fresenius Kabi to Commercialize PB016 (Biosimilar, Entyvio)

Shots: Polpharma has entered into a global licensing agreement with Fresenius Kabi to commercialize PB016, a biosimilar version of Takeda’s Entyvio (vedolizumab) for the treatment of mod. to sev. ulcerative colitis & Crohn’s disease As per the deal, Fresenius will obtain global commercialization rights to PB016, excl. Middle East & North Africa, while Polpharma will…

ByRidhi RastogiAugust 5, 2025

NEWS

Biocon Biologics Reports the US FDA’s Approval of Yesintek (Biosimilar, Stelara)

Shots: The US FDA has granted approval to the company’s Yesintek, a biosimilar version of J&J’s Stelara (ustekinumab) Biocon Biologics will commercialize Yesintek across the US by Feb 22, 2025, following FDA approval, under a settlement and licensing agreement with Janssen Yesintek is a monoclonal antibody indicated for the treatment of Crohn’s disease, Ulcerative Colitis,…

ByDipanshu DixitDecember 1, 2024

NEWS

Bio-Thera Collaborates with Gedeon Richter for BAT2206 (Biosimilar, Stelara)

Shots: Bio-Thera has entered into an exclusive commercialization and licensing agreement with Gedeon Richter for BAT2206, a biosimilar version of Stelara (ustekinumab) Bio-Thera will handle development, manufacturing & supply of BAT2206 while Richter will have exclusive commercialization rights across the EU, UK, Switzerland & selected regions. Bio-Thera has already submitted regulatory filing with the EMA…

ByDipanshu DixitOctober 9, 2024

NEWS

Fresenius Kabi and Formycon Report the US FDA’s Approval of Otulfi (Biosimilar, Stelara)

Shots: The US FDA has approved Otulfi (SC & IV), biosimilar of Stelara (ustekinumab), to treat Crohn’s disease, ulcerative colitis, mod. to sev. plaque PsO & active psoriatic arthritis. Fresenius Kabi can market Otulfi by Feb 22, 2025 Approval was based on analytical, pre-clinical, clinical & manufacturing data, showing similar efficacy, safety, PK & immunogenicity…

ByDipanshu DixitSeptember 30, 2024

Takeda Reports Topline P-III (LATITUDE) Trials Findings on Zasocitinib in Plaque Psoriasis (PsO)

Celltrion’s Steqeyma (Biosimilar, Stelara) Receives the CHMP Positive Opinion for Multiple Immune-Mediated Diseases

Sandoz Launches Tyruko (Biosimilar, Tysabri) in the US

J&J Reports Long-Term Extension Results from GALAXI-2, GALAXI-3, and GRAVITI Trials of Tremfya (Guselkumab) for Crohn’s Disease

Polpharma Biologics Enters into Licensing Deals with MS Pharma for Multiple Biosimilar Candidates

Bio-Thera Secures the EC’s Approval for Usymro (Biosimilar, Stelara)

Polpharma Biologics Collaborates with Fresenius Kabi to Commercialize PB016 (Biosimilar, Entyvio)

Biocon Biologics Reports the US FDA’s Approval of Yesintek (Biosimilar, Stelara)

Bio-Thera Collaborates with Gedeon Richter for BAT2206 (Biosimilar, Stelara)

Fresenius Kabi and Formycon Report the US FDA’s Approval of Otulfi (Biosimilar, Stelara)

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