Ophthalmology

Newly Created Viatris Joins the Biosimilars Forum

November 30, 2020

Tony Hagen

Article

The merger of Pfizer's Upjohn division and Mylan has created a biosimilars powerhouse with global reach.

Henlius, Celltrion Group Report Product Development Advances

November 28, 2020

Tony Hagen

Article

A Shanghai Henlius Biotech study demonstrates equivalence for its bevacizumab candidate, and Celltrion moves forward with a trial for a SARS-CoV-2 candidate.

Bio-Thera Solutions Files for EU Bevacizumab Approval

November 25, 2020

Tony Hagen

Article

This marks the first time a Chinese company has filed application for marketing of a biosimilar outside of China. Bio-Thera of Guangzhou, China, said a US application is pending.

Alvotech Scientific Officer Describes Company's Global Biosimilars Strategy

November 25, 2020

Tony Hagen

Article

Joseph E. McClellan, PhD, MBA, discussed navigation of regulatory hurdles as the company continues its quest to line up distribution partnership deals across the globe.

Providers Exploit Minor Differences Between Innovator Drugs and Biosimilars

November 24, 2020

Skylar Jeremias

Article

Minute differences between biosimilars and reference products are not considered “clinically meaningful,” but these differences are exploitable when it comes to addressing allergies related to originator products.

FDA Accepts Ranibizumab BLA From Samsung Bioepis and Biogen

November 18, 2020

Tony Hagen

Article

The FDA's acceptance of the biologics license application (BLA) moves the companies one step closer to entering the US ophthalmology treatment sphere with a biosimilar.

Genentech Files to Block Marketing of Centus' Bevacizumab Biosimilar

November 17, 2020

Tony Hagen

Article

The reference product rights holder contends that Centus has not provided complete information about its manufacturing processes related to FKB238, the proposed biosimilar.

IGBA Launches Global Biosimilars Week

November 16, 2020

Tony Hagen

Article

The International Generic and Biosimilar Medicines Association (IGBA) hopes to build momentum for the use of biosimilars.

Samsung Bioepis’ Ranibizumab Candidate Shows Equivalence in Updated Results

November 11, 2020

Tony Hagen

Article

Results up to week 52 in the phase 3 study show that primary end points were met for best corrected visual acuity and central subfield thickness.

Formycon and Bioeq Adjust Submission Strategy for Lucentis Biosimilar

November 9, 2020

Skylar Jeremias

Article

Formycon and Bioeq say resubmission of the biologics license application for their ranibizumab candidate will not affect launch timing in US or European markets.

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