AbbVie Reports EMA Filing for Skyrizi SC Induction to Treat Active Crohn’s Disease

Shots: The EMA has received an application seeking approval for Skyrizi (risankizumab; SC induction) for the treatment of adults with moderately to severely active Crohn's disease (CD) Application was backed by the P-III (AFFIRM) trial assessing Skyrizi (SC) as an induction treatment in above-mentioned pts (n=289) in 3 periods: Period A compared Skyrizi against PBO for 12wks., blinded…

ByRidhi Rastogi4 days ago

NEWS

Biocon’s Yesintek (Biosimilar, Stelara) Receives Health Canada Approval for its Autoinjector Presentation

Shots: Health Canada has approved Yesintek Autoinjector (45 mg/0.05 mL & 90 mg/mL), a biosimilar version of Stelara (ustekinumab) Yesintek is indicated for the treatment of mod. to sev. plaque psoriasis in pts (≥6yrs.), active psoriatic arthritis in adults, mod. to sev. active Crohn’s disease & ulcerative colitis in adults Yesintek was previously approved as…

ByRidhi RastogiJuly 30, 2026

NEWS

Takeda Reports the P-III (LATITUDE) Studies Data on Zasocitinib in Plaque Psoriasis

Shots: Takeda has reported the 2 P-III (Latitude PsO 3001 & PsO 3002) trial results assessing zasocitinib (QD, PO) in 693 & 1108 adults, respectively, with mod. to sev. PsO, where both studies showed improved NAPSI scores vs PBO at 16wks. Trials also showed that 77% (3001) & 74% (3002) pts reached ssPGA 0/1 response…

ByRidhi RastogiJuly 17, 2026

NEWS

Alvotech Reports US FDA BLA Acceptance of AVT16 (Biosimilar, Entyvio)

Shots: The US FDA has accepted BLA for AVT16, a biosimilar to Entyvio (vedolizumab) as a lyophilized vial for IV administration, to treat adults with mod. to sev. active ulcerative colitis & Crohn’s disease BLA is supported by analytical, PK, & immunogenicity data demonstrating biosimilarity between AVT16 & the reference product, plus Alvotech has filed a…

ByRidhi RastogiJune 8, 2026

NEWS

Teva and Sanofi Report P-IIb (RELIEVE UCCD) LTE Study Data on Duvakitug in Inflammatory Bowel Disease

Shots: Teva & Sanofi have reported RELIEVE UCCD LTE study data evaluating duvakitug (450 or 900mg, SC, Q4W) in 130 pts with ulcerative colitis (UC) or Crohn’s disease (CD) following P-IIb (RELIEVE UCCD) induction study Trial showed that at Wk. 44 of maintenance, 58% (900mg) & 47% (450mg) of UC pts achieved clinical remission per mMS,…

ByRidhi RastogiFebruary 17, 2026

NEWS

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

AbbVie Reports EMA Filing for Skyrizi SC Induction to Treat Active Crohn’s Disease

Biocon’s Yesintek (Biosimilar, Stelara) Receives Health Canada Approval for its Autoinjector Presentation

Takeda Reports the P-III (LATITUDE) Studies Data on Zasocitinib in Plaque Psoriasis

Alvotech Reports US FDA BLA Acceptance of AVT16 (Biosimilar, Entyvio)

Teva and Sanofi Report P-IIb (RELIEVE UCCD) LTE Study Data on Duvakitug in Inflammatory Bowel Disease

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

Contact US

FOLLOW US