News

Daewon Pharmaceutical has launched Terrosa, a teriparatide biosimilar, on the Republic of Korea market, after signing a domestic sales agreement with Richter-Helm Biotec. The drug is intended for the treatment of osteoporosis.

Ruth O’Regan, of the University of Wisconsin Carbone Cancer Center, discusses improving the patient discussion on biosimilars, in an interview.

On the heels of positive clinical studies, Fresenius Kabi said the European Medicines Agency will review its product application for a pegfilgrastim biosimilar.

Here are the top 5 biosimilars articles for the week of May 18, 2020.

A study of coverage decisions by some of the nation’s largest payers indicates biosimilars get preferred status just 14% of the time.

Fresenius Kabi’s pegfilgrastim biosimilar candidate has demonstrated a similar safety and immunogenicity profile to the reference product (Neulasta).

After completing a 24-week phase 3 trial, Samsung Bioepis said its biosimilar ranibizumab (SB11) has demonstrated clinical equivalence to reference Lucentis for the treatment of neovascular age-related macular degeneration.

Taiwan-based JHL Biotech said it has initiated a phase 1 clinical trial of its denosumab biosimilar candidate for bone loss.

Biocon said a subsidiary’s manufacturing centers in Bengaluru, India, were cleared by European Union authorities for biosimilar production.

If it has strong intentions to develop the IL-23 agent brazikumab for commercialization, AstraZeneca did not show its hand when it acknowledged receipt of the agent from Allergan last week.

As it emerges from organizational restructuring, Outlook Therapeutics expresses confidence in its bevacizumab candidate for retinal diseases.

Here are the top 5 biosimilars articles for the week of May 11, 2020.

In a trio of studies, investigators were able to demonstrate equivalency of Samsung Bioepis’ trastuzumab biosimilar in various settings.

Icelandic company Alvotech said clinical trials for its adalimumab candidate have demonstrated equivalence to reference product Humira.

Although India is far ahead of other countries in terms of biosimilar approvals, its regulatory structure may hinder efforts for international sales.

India entered the biosimilar market early and has nearly 100 approved biosimilars, but experts say its regulatory system is not considered world-class, which may hinder international marketing of these products.

Celltrion is pinning its hopes on a higher-concentration formulation of adalimumab to gain elbow room among multiple competing products.

Investigators use the HERITAGE trial findings to argue for a more precise way of measuring clinical equivalence for biosimilars.

German biopharmaceutical company Formycon has postponed its annual meeting due to the coronavirus disease 2019 (COVID-19) pandemic.

Australia’s secretive drug approval system gives what some believe is an unfair advantage to rival drug companies.

With successful findings from a phase 3 trial of its bevacizumab biosimilar candidate, Iranian company AryoGen Pharmed is a step closer to commercialization of this product.

Coherus Biosciences, of Redwood City, California, sees continued profitability, thanks largely to sales of its pegfilgrastim biosimilar, Udenyca, launched in January 2019.

Here are the top 5 biosimilars articles for the week of May 4, 2020.

A retrospective study of physician surveys on biosimilars demonstrated that understanding physician attitudes toward biosimilars is crucial to improving uptake of these agents.

With 1 biosimilar launch and expanded indications for another biosimilar so far this year, Teva Pharmaceutical Industries reported higher biosimilar revenues in the first quarter of 2020.

The Federal Trade Commission was deeply divided over whether the AbbVie-Allergan $63 billion merger plan would allow for a sufficiently competitive marketplace.

Although the totality of the evidence is reassuring, the jury is still out on nonmedical switching to biosimilars, according to new study results.

Bausch + Lomb has secured the rights to commercialize a ranibizumab biosimilar in the United States and Canada.

Expanding access to biosimilar pegfilgrastim (Ziextenzo) for patients at intermediate risk of febrile neutropenia and converting patients at high risk who are on the reference product (Neulasta) could save millions in healthcare costs, according to new study results.

Interest in tocilizumab has grown lately as Roche has a clinical trial underway to evaluate efficacy in coronavirus disease 2019 (COVID-19)–related pneumonia.