Tags : Biosimilar

Biosimilars Regulatory

Boehringer Ingelheim’s Cyltezo (biosimilar, adalimumab) Receives the US FDA’s sBLA

Shots: The approval is based on the P-III VOLTAIRE-X trial evaluates the effects of multiple switches b/w Humira and Cyltezo in patients with multiple chronic inflammatory diseases The study showed that Cyltezo was equivalent to Humira & demonstrated that switching several times b/w Cyltezo and Humira resulted in no clinical differences in PK, efficacy, immunogenicity, […]Read More

Biosimilars

Formycon and Bioeq Report the US FDA’s Acceptance of BLA

Shots: The US FDA has accepted the BLA for FYB201, a biosimilar referencing Lucentis for review and assigned a target action date for the application for Aug’2022 Following the approval, Coherus will commercialize FYB201 in the US whereas Formycon will participate economically in US sales through its interest in royalties paid by Coherus to Bioeq […]Read More

Biosimilars Regulatory

Apobiologix’s Bambevi (biosimilar, bevacizumab) Receives Health Canada Approval for Multiple

Shots: Apobiologix expands its footprints in Canada with the approval of Bambevi + CT to treat colorectal, lung, brain and ovarian cancer The approval is coupled with well-established Apobiologix supportive care products that enable the company to transform access to affordable therapies in oncology and other indications In 2016, Apobiologix launched its first product, Grastofil […]Read More

Biosimilars Clinical Trials

Tanvex Presents Results of TX05 (biosimilar, trastuzumab) in P-III Study

Shots: The P-III study evaluates TX05 (biosimilar, trastuzumab) vs Herceptin in 809 patients with HER2-positive early-stage breast cancer The results showed that the proportions of patients that meet pCR criteria for equivalence were highly similar b/w TX05 (48.8%) and TRA (45.3%) cohorts; ORR (84.3%) & (85.0%); CR; PR and stable disease were also highly similar, […]Read More

Biosimilars Clinical Trials

Samsung Bioepis Presents Five-year Follow-up Results of Ontruzant (biosimilar, trastuzumab)

Shots: The P-III study evaluates the cardiac safety profiles & efficacy of Ontruzant vs reference trastuzumab in 367 patients with HER2 positive early or LA BC for 4yrs. after randomization Patients were randomized to receive 8 cycles of either Ontruzant or TRZ with concurrent neoadjuvant CT. After surgery, patients received 10 cycles of biosimilar trastuzumab […]Read More