Shots:
Celltrion has launched SteQeyma (ustekinumab-stba) injection, a biosimilar to Stelara, for all indications of the reference products following the US FDA’s approval in Dec 2024
Approval was supported by various clinical evidence incl. P-III trial of SteQeyma vs Stelara for mod. to sev. plaque PsO, with 1EP as rate of change in the PASI for skin…
Shots:
The US FDA has approved & granted interchangeability designation to Omlyclo, a biosimilar to Xolair (omalizumab) for the treatment of mod. to sev. persistent asthma, CRSwNP, IgE-mediated food allergy, & chronic spontaneous urticaria (CSU)
Approval was based on multiple clinical evidence, incl. P-III trial assessing Omlyclo (150mg, Q4W) vs Xolair (300mg, Q4W) in…
Shots:
The EC has approved Opdivo + Yervoy as 1L therapy to treat inoperable or advanced HCC adult pts in 30 EEA states; sBLA under the US FDA’s priority review (PDUFA: Apr 21, 2025)
Approval was based on P-III (CheckMate-9DW) trial assessing Opdivo (1mg/kg, Q3W) + Yervoy (3mg/kg, Q3W), followed by Opdivo alone (480mg,…
Shots:
The US FDA has approved Encelto (revakinagene taroretcel-lwey) to treat macular telangiectasia type 2 (MacTel); commercially available in the US by Jun 2025
Approval was based on P-III trial data demonstrating reduced macular photoreceptor loss for ~24mos. post-implantation
Encelto (intravitreal implant) utilizes an encapsulated cell therapy tech to continuously deliver ciliary neurotrophic…
Shots:
Recently, the European Commission approved AbbVie’s Skyrizi for the treatment of adults with moderate to severe active Ulcerative Colitis
The approval was based on positive data from the P-III INSPIRE induction trial and COMMAND maintenance study
Today, at PharmaShots we have Sofie Berg, the therapeutic area head of international immunology, International Medical Affairs, at…
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
The major highlights were the US FDA’s approval of Sandoz’s Enzeevu for Treating Neovascular Age-Related…
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
The major highlights were the US FDA’s approval of Samsung Bioepis’ Epysqli for Treating Paroxysmal…
Shots:
East Asia and East Europe report significant incidences of Gastric Cancer. In 2022, Japan registered around 44,000 mortalities due to Gastric Cancer
VYLOY, an anti-claudin 18.2 (CLDN18.2) monoclonal antibody, received Japan’s approval in combination with chemotherapy for patients with HER2 -ve, CLDN18.2+ve, unresectable, advanced, or recurrent gastric cancer
Today, at PharmaShots we have Moitreyee…
Shots:
Recently AstraZeneca’s FASENRA (benralizumab) received approval from the US FDA as an add-on maintenance treatment for patients (≥ 6 yrs.) with severe asthma and with an eosinophilic phenotype
Today, at PharmaShots we have with us Donna Carstens, Senior Medical Director Respiratory, Fasenra at AstraZeneca
Donna shares insights from the TATE study an open-label, multinational,…
Shots:
The EC approved 10 New Chemical Entities in April 2024, leading to treatments for patients and advances in the healthcare industry
In April 2024, the major highlighted drugs were Takeda’s Fruzaqla to treat Adults with mCRC and Johnson & Johnson’s Rybrevant for the treatment NSCLC
PharmaShots has compiled a list of 5 drugs that have received positive…

