Tags : Avastin

Biosimilars

Bio-Thera Solutions Reports the US FDA’s Acceptance of BLA for

Shots: The BLA submission is based on data from P-III clinical comparison study that demonstrated BAT1706 is highly similar to reference bevacizumab in clinical efficacy, safety, and immunogenicity. The anticipated BsUFA date is Nov 27, 2021 The BLA seeks approval of BAT1706 for mCC in combination with fluorouracil-based CT, 1L treatment for nsq. NSCLC, recurrent […]Read More

Top 20

Top 20 Prescription Drugs Based on 2019 Revenue

The average life expectancy span of Human Beings are increased due to better medical facilities and drugs developed by Biopharma companies. Pharmaceutical products or drugs or medicines are being produced for a wide range of medical sectors. It includes the lifesaving drugs or the major therapy area including immunology, cardiology, and neurology but are they […]Read More

Biosimilars

Biocon and Mylan Report the US FDA Acceptance of BLA

Shots: The US FDA has accepted the BLA for Mylan’s MYL-1402O, a proposed biosimilar to Avastin (bevacizumab) for review under the 351(k)pathway with its anticipated BsUFA date as Dec 27, 2020 The BLA is based on P-III study assessing proposed biosimilar bevacizumab vs Avastin along with CT for 18wks. in 671 patients with stage 4 […]Read More

Regulatory

Roche Reports Submission of sBLA to the US FDA for

Shots: The sBLA is based on P-III IMbrave150 study involve assessing of Tecentriq (1200mg, IV) + Avastin (IV, 15 mg/kg) vs Sorafenib (PO, 400mg, bid) in 501 patients in a ratio 2:1 with unresectable HCC prior not treated with systemic therapies The P-III IMbrave150 study results: 42% reduction in risk of death; 41% reduction in […]Read More