Prestige Biopharma Reports the CHMP’s Positive Opinion of Tuznue (Biosimilar, Herceptin)

Shots: The CHMP has granted positive opinion to Tuznue, a biosimilar version of Herceptin (trastuzumab) for the treatment of HER2+ve early & metastatic breast cancer as well as HER2+ve metastatic gastric cancer The recommendation was supported by the data showing similarity b/w Tuznue vs Herceptin under P-I & P-III trials to evaluate the PK profile,…

ByDipanshu DixitJuly 31, 2024

NEWS

Dr. Reddy’s Ituxredi (Biosimilar, MabThera) Receives the CHMP’s Positive Opinion

Shots: The CHMP has granted a positive opinion to DRL_RI (Ituxredi), a biosimilar of MabThera (rituximab) The approval, if granted, would be applicable across the whole EU plus Norway, Iceland & Liechtenstein. A separate MAA will be submitted to the MHRA as per reliance route under the IRP Ituxredi (CD20 directed cytolytic Ab) is for the…

ByDipanshu DixitJuly 29, 2024

NEWS

Fresenius Kabi and Formycon Report the CHMP’s Positive Opinion of FYB202 (Biosimilar, Stelara)

Shots: The CHMP has granted a positive opinion to Fresenius & Formycon’s FYB202, a biosimilar version of Stelara (ustekinumab), with the decision anticipated during Q4’24 The opinion was supported by non-clinical & clinical studies plus manufacturing data, depicting similar effectiveness, safety & PK profile of FYB202 vs Stelara among moderate to severe psoriasis vulgaris (plaque psoriasis)…

ByDipanshu DixitJuly 26, 2024

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in June 2024

Shots: The EMA granted Positive Opinion to 4 Biologics and 3 New Chemical Entities in June 2024, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were Merck’s Winrevair to treat Pulmonary Arterial Hypertension (PAH) and Roche’s PiaSky for Paroxysmal Nocturnal Haemoglobinuria (PNH) PharmaShots has compiled a list of 5 drugs that…

ByDipanshu DixitJuly 23, 2024

INSIGHTS+

Disease of the Month – Small Cell Lung Cancer

Shots: Small cell lung cancer (SCLC) aka Oat cell carcinoma is a rare & fast-growing lung cancer and ~15% of bronchogenic carcinomas are SCLC In this reprise of our Disease of the Month report, we bring an illuminating account of SCLC with a dive analysis of epidemiology, market size, disease management, available therapies, patient advocacy…

ByDipanshu DixitJuly 18, 2024

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in May 2024

Shots: The EMA approved or granted Positive Opinions to 5 Biologics and 7 New Chemical Entities in May 2024, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were BMS’ Opdivo + cisplatin & gemcitabine to treat Urothelial Carcinoma and Takeda’s ADAMTS13 for the treatment cTTP PharmaShots has compiled…

ByDipanshu DixitJune 20, 2024

NEWS

Bio-Thera Gains the CHMP’s Positive Opinion of Avzivi (Biosimilar, Avastin)

Shots: The CHMP has granted a positive opinion to the company’s Avzivi (bevacizumab), a biosimilar of Avastin to treat metastatic colorectal cancer The opinion was based on a P-I study assessing the PK, safety & immunogenicity of Avzivi vs EU & US reference product among healthy subjects & a P-III confirmatory trial of Avzivi…

ByDipanshu DixitJune 3, 2024

NEWS

The EC Grants Approval to Celltrion’s Omlyclo (Biosimilar, Xolair)

Shots: Following the CHMP’s recommendation for marketing authorization in Mar 2024, the company’s Omlyclo (biosimilar to Xolair) has obtained the EC’s approval for treating allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP) The approval was supported by the results from P-III clinical evaluation to determine the safety, efficacy & PK…

ByDipanshu DixitMay 23, 2024

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in April 2024

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…

ByDipanshu DixitMay 21, 2024

NEWS

Biogen Receives EMA’s CHMP Positive Opinion for Tofidence (Biosimilar, Roactemra)

Shots: The EMA’s CHMP has issued a positive opinion recommending approval of Tofidence (Biosimilar, Roactemra; IV) to treat moderate to severely active RA, PJIA, SJIA, and COVID-19 The opinion was based on evidence from extensive analytical characterization and PK, safety & immunogenicity of TOFIDENCE including the P-I study examined healthy volunteers compared to the EU…

ByDipanshu DixitApril 25, 2024

Prestige Biopharma Reports the CHMP’s Positive Opinion of Tuznue (Biosimilar, Herceptin)

Dr. Reddy’s Ituxredi (Biosimilar, MabThera) Receives the CHMP’s Positive Opinion

Fresenius Kabi and Formycon Report the CHMP’s Positive Opinion of FYB202 (Biosimilar, Stelara)

Insights+: EMA Marketing Authorization of New Drugs in June 2024

Disease of the Month – Small Cell Lung Cancer

Insights+: EMA Marketing Authorization of New Drugs in May 2024

Bio-Thera Gains the CHMP’s Positive Opinion of Avzivi (Biosimilar, Avastin)

The EC Grants Approval to Celltrion’s Omlyclo (Biosimilar, Xolair)

Insights+: EMA Marketing Authorization of New Drugs in April 2024

Biogen Receives EMA’s CHMP Positive Opinion for Tofidence (Biosimilar, Roactemra)

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