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Novo Nordisk
NEWS

Novo Nordisk’s Alhemo Gains the CHMP’s Positive Opinion as a Prophylatic Treatment of Hemophilia A or B

      Shots:    The CHMP has recommended Alhemo (QD, SC) as a prophylactic treatment of hemophilia A/B with inhibitors in patients (≥12yrs.), with the EC’s decision anticipated within ~2mos.    The opinion was based on the P-III (explorer7) study assessing the efficacy & safety of Alhemo to treat haemophilia A or B with inhibitors. Alhemo will be available…
October 18, 2024

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Disease of the Month – Psoriatic arthritis
INSIGHTS+

Disease of the Month – Psoriatic arthritis

Shots: Psoriatic arthritis is a chronic inflammatory condition characterized by joint pain, stiffness and swelling  In this reprise of our Disease of the Month report, we present an enlightening description of Psoriatic arthritis with a thorough study of epidemiology, market size, disease management, potential medicines, patient advocacy groups, and the key players involved     For a…
October 16, 2024

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Pfizer
NEWS

Pfizer Reports the US FDA’s Approval of Hympavzi to Treat Hemophilia A/B without Inhibitors in Adults and Adolescents 

Shots:    The US FDA has approved Hympavzi (QW, SC) as a prophylactic treatment to prevent bleeding episodes in patients (≥12yrs.) with hemophilia A & B without FVIII & FIX inhibitors, respectively. It has also received the CHMP’s positive opinion for the same  Results from pivotal P-III (BASIS) study, assessing Hympavzi in patients (12-75yrs.) with severe…
October 11, 2024

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NEWS

Dong-A ST Reports the US FDA’s Approval of Imuldosa (Biosimilar, Stelara) 

Shots:  Following the BLA submission by Accord BioPharma (Intas Pharmaceuticals’ subsidiary) in 2023, the US FDA has granted approval to Imuldosa, a biosimilar version of Stelara (ustekinumab). Its MAA has also been accepted by the EMA in 2023  Intas Pharmaceuticals with its subsidiaries (Accord BioPharma & Accord Healthcare) will commercialize the biosimilar across the US,…
October 11, 2024

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Roche
NEWS

Roche’s Reports the US FDA’s Approval of Itovebi as a Treatment for HR+ and HER2- breast cancer with a PIK3CA mutation 

Shots:    The US FDA approved Itovebi + Ibrance & fulvestrant as a 1L treatment in adults with endocrine-resistant, PIK3CA-mutated, HR+ & HER2- locally advanced or metastatic breast cancer, based on the P-III (INAVO120) trial  P-III (INAVO120) trial assessed the safety and efficacy of Itovebi + Ibrance & fulvestrant vs PBO + Ibrance & fulvestrant (n=…
October 11, 2024

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NEWS

Alvotech Reports the EMA’s Acceptance of MAA for AVT03 (Biosimilar, Prolia and Xgeva) 

Shots:  The EMA has accepted the marketing authorization application of AVT03, a biosimilar version of Prolia & Xgeva (denosumab)  Submission was based on the AVT03-GL-C01 trial among postmenopausal women (n=532) with osteoporosis as well as AVT03-GL-P01 (n=209) & AVT03-GL-P03 (n=208) studies among healthy adults, depicting similarity in efficacy, safety, immunogenicity & PK b/w the drugs …
October 10, 2024

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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…
October 9, 2024

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Teva
NEWS

Teva Reports the Acceptance of Regulatory Submissions for TVB-009P (Biosimilar, Prolia) by the US FDA and EMA 

Shots:  The US FDA and the EMA has accepted Teva’s applications for TVB-009P, biosimilar version of Prolia (denosumab), for all the approved indications, with their decisions anticipated during H2’25  Submissions were built upon the data from P-III (TVB009-IMB-30085) study assessing safety & efficacy of TVB-009P vs Prolia among women with postmenopausal osteoporosis as well as…
October 8, 2024

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Key Biosimilars Events of September 2024
INSIGHTS+

Key Biosimilars Events of September 2024

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 and…
October 3, 2024

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