Tags : Semglee

Biosimilars

Mylan and Biocon Receive the US FDA’s Approval for Semglee

Shots: The US FDA’s approval is based on comprehensive analytical, preclinical, and clinical programs (including the INSTRIDE (1&2) studies assessing MYL-1501D (qd) vs Lantus in 558 T1DM & 560 T2DM patients for 52wks. & 24wks. respectively. The 1EPS is changed from baseline in HbA1c after 24 wks. The INSTRIDE demonstrated no difference in safety, efficacy, […]Read More

Insights+

Insights+ Key Biosimilars Events of August 2019

Biosimilars are key alternatives for costly Biologics therapies and saving million 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 biosimilar space […]Read More

Biosimilars Regulatory

 Biocon Receives EU’s GMP Certification for its Semglee (biosimilar,

Shots: Biocon has received EMA’s certificate of GMP compliance from European inspection authority, Health Products Regulatory Authority (Ireland) and expand its capacities multi-fold with the new large-scale devices facility to meet the need of patients with diabetes in EU The manufacturing facility at Malaysia was inspected in May’2019 and is Asia’s largest integrated insulins facility […]Read More