Rheumatology

Mylan and Lupin have received market authorization for their etanercept biosimilar (Nepexto, YLB113) in Europe for all indications of the reference product.

Clinical trials leading up to biosimilar approval may not reveal the full safety and efficacy profile of biosimilars vs reference products, and postmarketing studies may be essential to elucidate any differences, investigators said.

The rituximab biosimilar candidate ABP 798 met primary and secondary end points for safety, efficacy, and immunogenicity in a study presented at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology (ASCO).

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

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.

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).

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

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.

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

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

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

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

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

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

Although Pfizer has offered a more attractive discount for its rituximab biosimilar, Teva Pharmaceutical Industries and Celltrion Healthcare have decided not to match that discount for their own rituximab biosimilar, which is more costly.

A New Zealand study of patients with rheumatic conditions suggests that providers need to be mindful of patient attitudes toward biosimilars to prevent biased therapy choices and poor outcomes.

Posters presented at the Academy of Managed Care Pharmacy (AMCP) eLearning Days meeting this week from April 20 to 24 reveal important data on biosimilar utilization management, switching, and affordability.

A pathway model that incorporated use of biosimilars has shown great promise, according to Colin C. Edgerton, MD, executive chairman of the American Rheumatology Network.

Patients in an Australian clinic were generally open to using biosimilars but knew little about them, according to a recent study.

The Danish medical system saved 82.8% on adalimumab by switching almost all patients from the reference product to biosimilars, but such a benefit for the US healthcare system may not be possible, according to a new study.

Following close on the heels of its US approval for Ruxience (rituximab), Pfizer has gained the European Commission nod and aims to launch in coming months.

Self-insured companies could have saved $407 million to $1.4 billion in 2018 had they switched completely from reference biologics infliximab and filgrastim to biosimilars.

Mylan and Lupin have gained the necessary recommendation to begin marketing their etanercept biosimilar in Europe.

Alvotech Hf and DSH hope to get an adalimumab biosimilar approved in the United States, Europe, and selected Southeast Asia markets.

The American College of Rheumatology (ACR) has issued a list of recommendations for streamlining prior authorization to eliminate redundancy and improve access for patients.

In inflammatory rheumatic diseases, the nocebo effect may account for a portion of treatment failures among patients who were placed on biosimilars; however, discontinuations due to the nocebo effect can be difficult to diagnose due to the absence of diagnostic criteria, differences in pathologic backgrounds for each disorder, and the absence of specific neurochemical and neuroimaging studies, investigators found.

Stakeholder comments at a biosimilars forum staged by the FDA and Federal Trade Commission focused on improving the quality of information being disseminated about biosimilars and the need to make the approval process less burdensome for manufacturers.

Two regulatory experts said in an editorial that suffixes for biosimilars can support adverse event reporting and build provider and patient confidence in biosimilars.

The use of low-dose methotrexate in rheumatoid arthritis dates back more than 30 years, but despite these decades of clinical use, data on adverse effects have come mostly from observational studies rather than randomized controlled trials (RCTs), the authors say.