Tags : Formycon

Insights+

PharmaShots’ Key Highlights of Fourth Quarter 2020

The fourth quarter of 2020 contains multiple initiations of clinical trials, big approvals, and numerous deals. COVID-19 related news remains at the peak in this quarter Multiple companies received regulatory bodies’ EUA for their vaccines and treatments for COVID-19. Initiating with, Regeneron sought the US FDA’s EUA for REGN-COV2 Ab combination while Health Canada accelerated […]Read More

Insights+

Insights+ Key Biosimilars Events of November 2020

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 the patients. Hence, the providers are more likely to adopt biosimilars as a “reference […]Read More

Biosimilars

Formycon Reports BLA Resubmission Strategy for FYB201 (biosimilar, ranibizumab)

Shots: Formycon & Bioeq reported the BLA resubmission strategy for FYB201 (biosimilar referencing Lucentis) has been adjusted With the revised submission strategy, the companies expect a simplification of the approval procedure. The modified submission dossier is anticipated to be filed with the US FDA in H1’21 The adjustment of the regulatory strategy while optimizing the […]Read More

Insights+

Insights+ Key Biosimilars Events of August 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Mylan with its partner Lupin and Biocon launched Nepexto (biosimilar, etanercept) and Semglee (insulin glargine injection) in Germany & in the US, respectively. Additionally, Formycon and Bioeq planned to initiate P-III MAGELLAN-AMD Trial for its FYB203 (biosimilar, […]Read More

Biosimilars Regulatory

Formycon with its Partner BIOEQ Plans to Initiate P-III MAGELLAN-AMD

Shots: BIOEQ will sponsor the P-III study which will assess the FYB203 vs Eylea in patients with neovascular age-related macular degeneration (nAMD) to evaluate its efficacy, safety and immunogenicity. Additionally, the design of the study is developed in collaboration with the USFDA, EMA, PMDA The second program in ophthalmology will aim to strengthen and expand […]Read More

Biosimilars

Formycon To Update on its Biosimilar Programs

Formycon signs an agreement with Bioeq AG and manufacturing partner for resubmission of BLA for FYB201 project (biosimilar, ranibizumab). Bioeq AG is in talks with the US FDA for resubmission supporting manufacturing data in the H2’20 In Oct 2019, Formycon’s FYB202 (biosimilar, ustekinumab) has completed its P-I trial with its initiation of P-III trial in […]Read More

Insights+

Insights+ Key Biosimilars Events of October 2019

Biosimilars are key alternatives for costly Biologics therapies and saving millions of dollars of patients in multiple diseases. Hence physicians are likely to adopt biosimilars “a reference product to biologics” possessing similar therapeutic properties in terms of potency, safety, and efficacy to original biologic products. Our team at PharmaShots has summarized key events of the […]Read More