News

Here are the top 5 biosimilars articles for the week of May 25, 2020.

Fresenius Kabi has tapped pharmaceuticals distribution company medac to amplify sales of its pegfilgrastim biosimilar in Germany.

Fresenius Kabi USA announced that the FDA has accepted its biologics license application for the pegfilgrastim biosimilar candidate MSB11455.

Among the briefs filed in defense of the Affordable Care Act and, with it, the Biologics Price Competition and Innovation Act (BPCIA), is one from the Association for Accessible Medicines, which argues the BPCIA is vital to biosimilars market development.

CMS announced that its Part D Senior Savings Model designed to cut insulin costs for struggling Medicare beneficiaries is attracting broad insurer participation, indicating high potential for success.

Swedish researchers analyzing more than 10 years of data found that Omnitrope (biosimilar recombinant human growth hormone) is safe and effective in treating adult and pediatric patients with growth hormone deficiencies.

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.