News

Streamlining of biologics license applications (BLAs) in Britain is now official, and in the United States, legislators propose a ratings system to promote biosimilars.

A Canada study of the filgrastim biosimilar Grastofil demonstrated equivalence to Neupogen in candidates for autologous stem cell transplantation (ASCT), an extrapolated use.

Here are the top 5 biosimilar articles for the week of May 10, 2021.

A second class of biosimilars that are considered "interchangeable" could set biosimilars back in terms of acceptance, according to Albert Kim, MBA.

With COVID-19 on the retreat, Coherus BioSciences sees the advantage wearing off for Amgen's pegfilgrastim injector kit.

When it comes to biologics, there is a constant push and pull over patent rights. Some believe this is part of a healthy market-driven economy. Others are skeptical.

After being sued for allegedly stealing adalimumab process information, Alvotech fires back.

Investigators ranked biologics and Janus kinase 1 inhibitors based on past findings.

During a talk at the Medicines for Europe Biosimilar Medicines Conference, US and EU regulators discuss the potential for tailored approach to bring biosimilars to market sooner with less expense and wasted effort.

This is the third and final part of our series on National Comprehensive Cancer Network/Pfizer efforts to investigate issues of importance to biosimilar stakeholders.

Intellectual property attorneys from Axinn discuss the limitations of the Purple Book patent disclosure requirements and the burden these impose on biosimilar developers.

Advances in analytical testing have improved confidence in biosimilars, according to a Medicines for Europe panel.

Here are the top 5 biosimilar articles for the week of May 3, 2021.

Maria Manley, LLM, a life sciences expert and London-based partner with Sidley Austin, provides a deep-dive look at the complexities of Brexit and how it is likely to challenge the biologics industry.

Pfizer doubles down on its pledge to fight rebates, and Organon executives discuss the growth potential of this planned Merck spinoff.

The anatomy of an interchangeability switching study.

Amgevita is now broadly available across Canada.

Biosimilar companies partnered with other companies and saw earnings increases, while reference product corporations faced sales erosion from biosimilar competition.

There are multiple contenders now in the race to bring the first aflibercept (Eylea) biosimilar to market in the United States and European Union.

Representative Carolyn B. Maloney, D-New York, questions the use of pharmaceutical profits to defend against biosimilar competition.

Biocon tests the waters with itolizumab in pandemic-ravaged India, and Celltrion announces early success with an agent for the South African variant.

There's no end in sight for Enbrel (etanercept) sales erosion, but Amgen's biosimilars are holding their own, the company reported.

Here are the top 5 biosimilar articles for the week of April 26, 2021.

The results of Voltaire-X could persuade the FDA to authorize automatic substitution of the adalimumab biosimilar Cyltezo for its reference product (Humira), investigators believe.

With 20 biosimilar launches in the United States since 2015, opinions vary as to the strength of utilization.

How much muscle did Congress invest in a pair of bills recently signed by President Biden? The answer may lie in your willingness to believe.

The savings from pegfilgrastim biosimilars rapidly add up, according to a study simulation that accounted for hospital costs associated with the on-body injector.

Investigators tapped health system data to conduct an observational, real-world comparison of bevacizumab (Mvasi) vs the reference product (Avastin).

This is the second of a 3-part series on National Comprehensive Cancer Network/Pfizer efforts to investigate issues of importance to biosimilar stakeholders.

Medicinal packaging shouldn't remind patients that they have a condition, according to Samsung Bioepis.