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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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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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New Drug Designations - August 2024
INSIGHTS+

New Drug Designations – August 2024 

Shots:   PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. August month’s report includes designations allotted to 10 small molecules, 9 biologics, 7 cell & gene therapies, 1 vaccine, 2 radiopharmaceutical, 1 peptide, 1 antineoplastic and 2 devices   In August 2024, Invenra’s INV724 received the…
September 25, 2024

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Henlius and Intas
NEWS

Henlius and Intas’ Hetronifly (Serplulimab) Receives the CHMP’s Positive Opinion to Treat Extensive-Stage SCLC 

     Shots:    The positive opinion of Hetronifly (anti-PD-1 mAb) was supported by ASTRUM-005 study assessing it with CT vs PBO as a 1L treatment of ES-SCLC patients (n=585) in various regions. It is approved in China under the brand name Hansizhuang for the same  Henlius partnered with Intas in 2023 to develop & commercialize…
September 21, 2024

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Pfizer
NEWS

Pfizer Reports the CHMP’s Positive Opinion of Hympavzi (Marstacimab) to Treat Hemophilia A and B 

      Shots:    The CHMP has recommended Hympavzi (QW, SC) as a prophylactic treatment to prevent bleeding episodes in patients (≥12yrs.) with hemophilia A & B without FVIII & FIX inhibitors, respectively   The opinion was based on data of 116 subjects (12-75yrs.) from a pivotal P-III (BASIS) study treated with marstacimab (300mg loading dose followed by…
September 20, 2024

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NEWS

AbbVie Reports the CHMP’s Positive Opinion of Elahere (Mirvetuximab Soravtansine) to Treat Ovarian Cancer 

      Shots:    The CHMP has granted positive opinion to Elahere for treating FRα+, Pt-resistant & high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer in adults who have received 1 to 3 prior therapies. The decision is anticipated in Q4’24, with other reviews underway  The opinion was based on P-III (MIRASOL) study assessing Elahere…
September 20, 2024

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Viewpoints_Jacqueline Nielsen_Tahi Ahmadi
VIEWPOINTS

Unlocking Approval: Jacqueline Nielsen from AbbVie & Tahi Ahmadi from Genmab in a Riveting Conversation with PharmaShots

Shots:  Recently, the EMA’s CHMP adopted a positive opinion by recommending conditional marketing authorization for AbbVie and Genmab’s Tepkinly for the treatment of R/R Follicular Lymphoma  Today at PharmaShots, we have Jacqueline Nielsen, Head of Hematologic Oncology Affairs at AbbVie, and Tahi Ahmadi, EVP and CMO at Genmab, shedding light on this conditional marketing authorization…
September 18, 2024

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Exclusive_Ahsan Arozullah_2024
EXCLUSIVE

Advancing Urothelial Carcinoma Care: Ahsan Arozullah from Astellas Pharma in an Exclusive Interview with PharmaShots

Shots:  Recently, the CHMP of the EMA adopted a positive opinion for Astellas’ Padcev + Keytruda combination therapy as the first-line treatment of patients with unresectable or metastatic urothelial cancer  Today, in an exclusive coverage, we bring an enlightening conversation with Ahsan Arozullah from Astellas Pharma, sharing insights from the P-III EV-302 study  Astellas looks…
September 4, 2024

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