The Center for Biosimilars Staff

March 02, 2019

Mylan revealed in its recent fourth quarter 2018 earnings call that it had an initial advisory meeting with the FDA regarding a proposed biosimilar onabotulinumtoxinA, referencing the brand-name Botox.

February 28, 2019

On this Rare Disease Day, learn more about how biosimilars are poised to help treat patients with rare diseases.

February 27, 2019

Regulators in China have approved the country’s first ever biosimilar, a rituximab product referencing Rituxan. The product, HLX01, was developed by Henlius and will be primarily used in the treatment of non-Hodgkin lymphoma. Regulatory requirements that were applied in the analysis of the drug, say investigators who took part in its development, will set a precedent for analytical similarity assessments of biosimilars in China going forward.

February 26, 2019

A recent study aimed to evaluate patients’ and nurses’ preferences for the autoinjector for a biosimilar adalimumab marketed as Imraldi in the European Union versus autoinjectors of reference adalimumab or reference etanercept.

February 26, 2019

This month, biosimilar developer Sandoz filed suit against Amgen, asking the United States district court for the Northern District of California for a declaratory judgment of patent noninfringement and invalidity.

February 23, 2019

New psoriasis treatment guidelines released this month by the American Academy of Dermatology and the National Psoriasis Foundation outline the use of biologics in treating and managing psoriasis.

February 19, 2019

Biosimilar developer Sandoz today announced the launch of its biosimilar adalimumab, Hyrimoz, in Spain. The biosimilar, referencing Humira, was authorized for sale in the European Union in July 2018.

February 17, 2019

Originator and biosimilar anti–tumor necrosis factor (anti-TNF) therapies are widely used to treat inflammatory bowel disease (IBD) and are effective in reducing systemic inflammation and thereby reducing tissue damage. While these drugs have revolutionized the treatment of IBD, adverse events (AEs) related to these agents can cause morbidity and mortality, and gastroenterologists must be prepared to recognize and manage these AEs. A recently published review described AEs of particular concern with anti-TNFs and outlined their management.

February 15, 2019

The United Kingdom’s National Institute for Health and Care Excellence (NICE) today released a final appraisal of pertuzumab (Perjeta) together with intravenous trastuzumab and chemotherapy for the treatment of HER2-positive early breast cancer, and recommended pertuzumab for use in patients if they have lymph node–positive disease and if drug maker Roche adheres to its promised discount for the drug.

February 14, 2019

As brand-name biologics that have achieved strong sales begin to age, and as biosimilar developers grow closer to gaining approval for and launching their products, innovator biologic developers are taking on new strategies to defend their profits and market share.