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Insights+ Key Biosimilars Events of June 2024

Insights+ Key Biosimilars Events of June 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 NMPA’s approval of Simcere Zaiming’s Enlituo for Treating metastatic colorectal…

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The EC Approves Biogen’s Tofidence (Biosimilar, Roactemra) for Treating Arthritis and COVID-19 

   Shots:  The EC has approved Tofidence (IV), a biosimilar version of Roactemra, to treat moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19  The approval was based on clinical data showing the similarity of Tofidence vs Roactemra evaluated under the P-I study among healthy participants and P-III…

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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…

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Biogen’s Qalsody (tofersen) Receives CHMP’s Positive Opinion for the Treatment of Amyotrophic Lateral Sclerosis (ALS) 

Shots:   The opinion was based on the results from the P-III (VALOR) trial evaluating the safety & efficacy of Qalsody (100mg) vs PBO in ALS patients (n=108) associated with SOD1 mutations. The 1EPs of the study include changes in ALSFRS-R total score from baseline to wk.28 & 2EPs includes change in total cerebrospinal fluid SOD1…

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VIEWPOINTS_Kathleen Somera-Molina_2023

Kathleen Somera-Molina, Head of SMA Global Medical Affairs at Biogen Shares Insights on New SPINRAZA (nusinersen) Long-Term Data in SMA

Shots: Kathleen spoke about new long-term SPINRAZA (nusinersen) data presented at the 3rd International Scientific Congress She then explained the new findings from individuals with infantile-onset SMA who were treated with SPINRAZA in the pivotal ENDEAR study followed by the long-term extension SHINE study for up to 7 years The interview also discusses Biogen’s advances…

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Kathleen Somera-Molina, Head of SMA Global Medical Affairs at Biogen Shares Insights on New Data Published about SPINRAZA

Shots: Kathleen spoke about the results of a new study published in Advances in Therapy evaluating real-world adherence to SPINRAZA (nusinersen) with its unique dosing schedule among people with spinal muscular atrophy (SMA) She also talked about the overall adherence rates to nusinersen. She highlighted that adherence was higher during the maintenance phase than the loading phase…

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VIEWPOINTS_Dr. Mourad Farouk Rezk_2023

Dr. Mourad Farouk Rezk, Head of Global Medical & Development Biogen Biosimilars Shares Insights on BLA Acceptance for BIIB800

Shots: Dr. Mourad spoke about the acceptance of aBLA for BIIB800, a Tocilizumab biosimilar candidate for several autoimmune diseases, including rheumatoid arthritis He briefed about the study design and results from the P-III trial which supported the BLA filing This interview focuses on Biogen's notable progress in addressing challenging immunologic conditions, offering potential solutions to…

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